Efficacy of a nicotine inhaler in smoking cessation: a double-blind, placebo-controlled trial. Efficacy of a nicotine nasal spray in smoking cessation: a placebo-controlled, double-blind trial. A double blind study of 2 mg versus 4 mg nicotine-gum in an industrial setting. [Treatment of smoking: efficacy of the use of nicotine chewing gum. Double-blind study]. Smoking cessation with nicotine replacement therapy among health care workers: randomized double-blind study. [Smoking cessation using the transdermal nicotine system]. Pre-cessation nicotine replacement therapy: pragmatic randomized trial. Comparison of nicotine patch alone versus nicotine nasal spray alone versus a combination for treating smokers: a minimal intervention, randomized multicenter trial in a nonspecialized setting. Varying nicotine patch dose and type of smoking cessation counseling. Smoking cessation in primary care. A randomized controlled trial of nicotine-bearing chewing gum. Effect of transdermal nicotine delivery as an adjunct to low-intervention smoking cessation therapy. A randomized, placebo-controlled, double-blind study. A controlled trial of sustained-release bupropion, a nicotine patch, or both for smoking cessation. Nicotine-containing chewing gum as an anti-smoking aid. Transdermal nicotine therapy and primary care. Importance of counseling, demographic, and participant selection factors on 1-year quit rates. The Nebraska Primary Practice Smoking Cessation Trial Group. Individualizing nicotine replacement therapy for the treatment of tobacco dependence: a randomized trial. Nicotine vs placebo gum in general medical practice. [Weaning of young smokers using a transdermal nicotine patch]. Nicotine patch vs. nicotine lozenge for smoking cessation: an effectiveness trial coordinated by the Community Clinical Oncology Program. Effect of cost on the self-administration and efficacy of nicotine gum: a preliminary study. Effectiveness of extended-duration transdermal nicotine therapy: a randomized trial. Controlled trial of three weeks nicotine replacement treatment in hospital patients also given advice and support. A placebo controlled randomized trial of the effects of phenylpropanolamine and nicotine gum on cessation rates and postcessation weight gain in women. Nicotine inhaler and nicotine patch as a combination therapy for smoking cessation: a randomized, double-blind, placebo-controlled trial. Cue exposure treatment for smoking relapse prevention: a controlled clinical trial. Nicotine-replacement therapy with use of a transdermal nicotine patch--a randomized double-blind placebo-controlled trial. Nicotine patch therapy for smoking cessation combined with physician advice and nurse follow-up. One-year outcome and percentage of nicotine replacement. Matching high- and low-dependence smokers to self-help treatment with or without nicotine replacement. The transdermal nicotine patch: results of a randomised placebo-controlled trial. One-year evaluation of three smoking cessation interventions administered by general practitioners. Clinical trial comparing nicotine replacement therapy (NRT) plus brief counselling, brief counselling alone, and minimal intervention on smoking cessation in hospital inpatients. Randomized, double-blind, placebo-controlled study of transdermal nicotine patch for smoking cessation. Does nurse counseling or offer of nicotine gum improve the effectiveness of physician smoking-cessation advice? [Double-blind study of the efficacy of nicotine chewing gum for smoking cessation in the primary care setting]. Smoking cessation in women concerned about weight. The effect of nicotine, silver acetate, and placebo chewing gum on the cessation of smoking. The influence of smoking type and nicotine dependence. A double-blind randomized trial of nicotine nasal spray as an aid in smoking cessation. Nicotine nasal spray with nicotine patch for smoking cessation: randomised trial with six year follow up. Nicotine gum in smoking cessation: a placebo-controlled, double-blind trial. Smoking cessation during alcohol treatment: a randomized trial of combination nicotine patch plus nicotine gum. Effects of nicotine chewing gum and follow-up appointments in physician-based smoking cessation. Nicotine chewing gum in general practice: effect of follow up appointments. Efficacy of a nicotine mouth spray in smoking cessation: a randomised, double-blind trial. A comparison of psychological and pharmacological treatment in smoking cessation. Importance of baseline cotinine plasma values in smoking cessation: results from a double-blind study with nicotine patch. A randomised 2 x 2 factorial design to evaluate different smoking cessation methods. Nicotine patches for pregnant smokers: a randomized controlled study. Effects of behavioral skills training and schedule of nicotine gum administration on smoking cessation. Smoking cessation with four nicotine replacement regimes in a lung clinic. Smoking cessation among inner-city African Americans using the nicotine transdermal patch. Nurse-conducted smoking cessation in patients with COPD using nicotine sublingual tablets and behavioral support. Quitting by gradual smoking reduction using nicotine gum: a randomized controlled trial. A randomized, controlled trial of NRT-aided gradual vs. abrupt cessation in smokers actively trying to quit. Do heavy smokers benefit from higher dose nicotine patch therapy? High-dose nicotine patch therapy for smokers with a history of alcohol dependence: 36-week outcomes. Behavior therapy and the transdermal nicotine patch: effects on cessation outcome, affect, and coping. Two studies of the clinical effectiveness of the nicotine patch with different counseling treatments. Controlled trial of nicotine polacrilex gum with supportive measures. Nicotine gum and self-help manuals in smoking cessation: an evaluation in a medical context. Nicotine patch and self-help video for cigarette smoking cessation. The nicotine inhaler in smoking cessation. Controlled trial of transdermal nicotine patch in tobacco withdrawal. Transdermal nicotine plus support in patients attending hospital with smoking-related diseases: a placebo-controlled study. Smoking cessation in hospital patients given repeated advice plus nicotine or placebo chewing gum. Efficacy of a nicotine lozenge for smoking cessation. Efficacy of nicotine patch in smokers with a history of alcoholism. The nicotine patch in smoking cessation. A randomized trial with telephone counseling. Transdermal nicotine for smoking cessation in postmenopausal women. A randomized placebo-controlled clinical trial of 5 smoking cessation pharmacotherapies. Nicotine gum for pregnant smokers: a randomized controlled trial. Effect of pre-treatment with nicotine patch on withdrawal symptoms and abstinence rates in smokers subsequently quitting with the nicotine patch: a randomized controlled trial. Combined use of nicotine patch and gum in smoking cessation: a placebo-controlled clinical trial. Higher dosage nicotine patches increase one-year smoking cessation rates: results from the European CEASE trial. Collaborative European Anti-Smoking Evaluation. European Respiratory Society. A randomized, double-blind, placebo-controlled clinical evaluation of a nicotine sublingual tablet in smoking cessation. The use of nicotine chewing gum as an aid to stopping smoking. Stopping smoking. Do nicotine chewing-gum and postal encouragement add to doctors' advice. Smoking cessation in primary care - a randomized controlled trial of bupropione, nicotine replacements, CBT and a minimal intervention. The safety of transdermal nicotine as an aid to smoking cessation in patients with cardiac disease. The effects of nicotine gum and counseling among African American light smokers: a 2 x 2 factorial design. Safety and efficacy of the nicotine patch and gum for the treatment of adolescent tobacco addiction. Combined and separate treatment effects of nicotine chewing gum and self-control method. Smoking cessation in family practice: the effects of advice and nicotine chewing gum prescription. A randomized trial of nicotine-replacement therapy patches in pregnancy. Double blind trial of repeated treatment with transdermal nicotine for relapsed smokers. Dose effects of nicotine gum. A randomized trial of smoking cessation interventions in general practice in Italy. Randomised trial of nicotine patches in general practice: results at one year. Imperial Cancer Research Fund General Practice Research Group. A controlled trial of nicotine chewing gum in a smoking withdrawal clinic. Nicotine gum and behavioral treatment in smoking cessation. Nicotine gum and behavioral treatment: a placebo controlled trial. A double-blind trial of a 16-hour transdermal nicotine patch in smoking cessation. Smoking reduction with oral nicotine inhalers: double blind, randomised clinical trial of efficacy and safety. Nicotine gum and self-help behavioral treatment for smoking relapse prevention: results from a trial using population-based recruitment. An assessment of nicotine gum as an adjunct to freedom from smoking cessation clinics. Effectiveness of the nicotine inhaler for smoking cessation in an OTC setting. Comparative effectiveness of 5 smoking cessation pharmacotherapies in primary care clinics. Helping people to stop smoking: randomised comparison of groups being treated with acupuncture and nicotine gum with control group. Nicotine gum, 2 and 4 mg, for nicotine dependence. A double-blind placebo-controlled trial within a behavior modification support program. Measures of affect and nicotine dependence predict differential response to smoking cessation treatments. Comparing smoking treatment programs for lighter smokers with and without a history of heavier smoking. Effect of nicotine chewing gum in smoking cessation. A randomized, placebo-controlled, double-blind study. Effect of nicotine chewing gum in combination with group counseling on the cessation of smoking. Precessation treatment with nicotine skin patch facilitates smoking cessation. Mood management and nicotine gum in smoking treatment: a therapeutic contact and placebo-controlled study. Nicotine-mecamylamine treatment for smoking cessation: the role of pre-cessation therapy. Nicotine gum treatment before smoking cessation: a randomized trial. Mecamylamine combined with nicotine skin patch facilitates smoking cessation beyond nicotine patch treatment alone. Evaluation of a treatment approach combining nicotine gum with self-guided behavioral treatments for smoking relapse prevention. Smoking reduction promotes smoking cessation: results from a double blind, randomized, placebo-controlled trial of nicotine gum with 2-year follow-up. Precessation treatment with nicotine patch significantly increases abstinence rates relative to conventional treatment. Smoking cessation through the use of nicotine chewing gum: a double-blind trial in Thailand. Effectiveness of a cognitive orientation program with and without nicotine replacement therapy in stopping smoking in hospitalised patients. A randomized trial of naltrexone for smoking cessation. Combination of behavioral smoking cessation with transdermal nicotine substitution. Dose effects and predictors of outcome in a randomized trial of transdermal nicotine patches in general practice. Effect of nicotine nasal spray on smoking cessation. A randomized, placebo-controlled, double-blind study. Placebo controlled trial of nicotine chewing gum in general practice. Comparison of fixed-dose transdermal nicotine, tapered-dose transdermal nicotine, and buspirone in smoking cessation. Nicotine patches in smoking cessation: a randomized trial among over-the-counter customers in Denmark. [Randomized clinical trial: effectiveness of the cognitive-behavioral approach and the use of nicotine replacement transdermal patches for smoking cessation among adults in Rio de Janeiro, Brazil]. The effects of exercise and nicotine replacement therapy on smoking rates in women. Personalized smoking cessation: interactions between nicotine dose, dependence and quit-success genotype score. Efficacy of bupropion alone and in combination with nicotine gum. Nicotine replacement and behavioral therapy for smoking cessation in pregnancy. Transdermal nicotine replacement for hospitalized patients: a randomized clinical trial. Efficacy and safety of an over-the-counter transdermal nicotine patch as an aid for smoking cessation. A comparison of a nicotine sublingual tablet and placebo for smoking cessation. High-dose nicotine patch therapy. Percentage of replacement and smoking cessation. Nicotine-containing chewing gum in smoking cessation: a double blind trial with half year follow-up. Effect of nicotine chewing gum as an adjunct to general practitioner's advice against smoking. Effect of dose on nicotine's reinforcing, withdrawal-suppression and self-reported effects. A double-blind trial of a nicotine inhaler for smoking cessation. Effects of nicotine gum dose by level of nicotine dependence. Are higher doses of nicotine replacement more effective for smoking cessation? Over-the-counter nicotine patch therapy for smoking cessation: results from randomized, double-blind, placebo-controlled, and open label trials.
A non-combustible nicotine inhaler, administered orally, has been developed for treatment of smokers. The inhaler allows weaning from nicotine while maintaining partial reinforcement of the ritual/sensory phenomena of smoking. Subjects were randomly assigned to active (n = 112) and placebo (n = 111) groups. Some behavioral intervention occurred as a function of participation. Strict abstinence (primary outcome criterion) was defined by CO < or = 8 ppm with no slips allowed at any time and cotinine values < or = 14 at 1 year. Survival analysis showed active inhaler was superior to placebo (p < 0.01). Active vs. placebo success rates were: 63% vs. 47% (day 3), 46% vs. 28% (week 1), 36% vs. 19% (week 2), 33% vs. 16% (week 3), 29% vs. 14% (week 6), 24% vs. 10% (3 months), 17% vs. 9% (6 months) and 13% vs. 8% (1 year). chi 2 analyses were significant through 3 months but not at 6 months (p < 0.08) or 1 year. Craving was relieved with active inhalers at day 3 and week 1. Subjects averaged six inhalers/day. Cotinine levels were 57-61% of smoking levels. Common side effects included throat/mouth irritation and coughing. Failure was predicted by early slips. The inhaler is clearly useful for short-term smoking cessation with potential for long-term efficacy. Extended access to the inhaler and relapse prevention training could improve success rates. Another promising approach would be to combine the inhaler with a nicotine patch. Laboratory trials have demonstrated the efficacy of nicotine replacement in smoking cessation but absolute success rates are low. For many, nicotine gum is hard to use and transdermal nicotine is slow-acting and passive. A new, faster-acting nicotine nasal spray (NNS) can provide easily self-administered relief from cigarette withdrawal. The NNS was tested for safety and efficacy in smoking cessation. Two hundred and fifty-five smokers were randomized to NNS or a piperine placebo. Drug use was limited to 8-32 doses/day for 6 months. Subjects were tested while smoking and at post-cessation daily (week 1) with follow-up at weeks 2, 3, 6 and at 3 months, 6 months and 1 year. Continuous abstinence analyses (CO < or = 8 ppm; no slips) showed that NNS significantly enhanced success rates over placebo overall (p < 0.001) and at all test intervals. Differences at key intervals between active and placebo were: 63% vs. 40% (day 5), 51% vs. 30% (week 3), 43% vs. 20% (6 weeks), 34% vs. 13% (3 months), 25% vs. 10% (6 months) and 18% vs. 8% (1 year). Side effects were common but tolerable. Cotinine measures showed that replacement of nicotine approximated 30% of smoking levels. Hazard functions revealed relapse risks peaked at day 1, day 5 and 3 weeks for strict abstinence. It is concluded NNS is safe, efficacious and a viable alternative treatment for smoking cessation. In a double blind randomised trial to aid smoking cessation a 2 mg nicotine gum (n = 101) was compared with a 4 mg gum (n = 98), in smokers of at least 15 cigarettes/day. The trial involved blue and white collar workers and took place at their working place (industrial setting). Intervention during the one year follow-up period was minimal. At 3 months 36.2% of the 2 mg nicotine gum group reported to have stopped smoking, against 44.8% in the 4 mg group (non-significant difference). At one year in the 2 and 4 mg groups respectively 22.3 and 32.2% reported smoking abstinence (non significant difference). However in a sub-group with a higher nicotine-dependence score, only 18.5% were abstainers at one year in the 2 mg nicotine gum group against 32.9% in the 4 mg nicotine gum, which is a significant difference at the p = 0.05 level. This is however a post-hoc finding and should be taken with caution. nan To assess the smoking prevalence and efficacy of nicotine replacement therapy on the quitting rate after 3 weeks of therapy and after 1- and 5-year follow-up among health care workers with a smoking habit in Split, Croatia.
                Among 311 hospital health professionals included in the study, there were 112 (36%) smokers; 44 (39%) of them were physicians and 68 (61%) nurses. In a randomized double-blind study, 112 smokers were divided in 2 groups, applying daily either a transdermal nicotine system (TNS) or placebo patch over 3 weeks. Abstinence was evaluated via questionnaire and on the basis of carbon monoxide concentration measured in the exhaled breath.
                The abstinence rates after the 3-week intervention period were 39% in the TNS group and almost 20% in the control group (chi-square test, p=0.038). After one year, these rates declined to 23% and 16%, respectively (p=0.476), and converged to 18% and 14% (p=0.797), respectively, at 5-year follow-up.
                Short-term TNS treatment is effective in smoking cessation, although the effects steadily wane over time and the relapse rate is high. Continuous, structured, and composite efforts are needed for the maintenance of the non-smoking behavior. There are a lot of methods for smoking cessation but transdermal nicotine system (TNS) is one of the most popular. On a sample of more than 300 smokers we have formerly shown that TNS achieves higher abstinence rate than placebo (38%:21%). In the present study we have tested the optimal administration of TNS. 160 smokers were subdivided in 4 groups of 40, receiving either TNS or placebo, for 3 or 6 weeks. The abstinence rate was evaluated by appropriate questionnaires and measuring CO in the exhaled air. After 3 weeks of TNS 60% of the examinees were abstaining compared to 50% after 6 weeks; the abstinence rates in the placebo groups were 17.5% and 20%, respectively (p < 0.05). Short TNS treatment (3 weeks) is at least as effective as a longer one (6 weeks), which is relevant both medically and economically. To determine the effectiveness of 2 weeks' pre-cessation nicotine patches and/or gum on smoking abstinence at 6 months.
                Pragmatic randomized controlled trial.
                New Zealand.
                Eleven hundred adult, dependent smokers who called the New Zealand Quitline between March 2006 and May 2007 for support to stop smoking were randomized to 2 weeks of nicotine patches and/or gum prior to their target quit day followed by usual care (8 weeks of patches and/or gum plus support calls from a Quitline adviser), or to usual care alone.
                The primary outcome was self-reported 7-day point prevalence smoking abstinence 6 months after quit day. Secondary outcomes included continuous abstinence, cotinine-verified abstinence, daily cigarette consumption, withdrawal symptoms and adverse events.
                Six months after quit day 125 (22.7%) participants in the pre-cessation group and 116 (21.0%) in the control group reported 7-day point prevalence abstinence (relative risk 1.08 95% CI: 0.86, 1.35, P = 0.4, risk difference 1.7%, 95% CI: -3.2%, 6.6%). However, when pooled in a meta-analysis with other pre-cessation trials a moderate benefit of about a one-quarter increase in cessation rates was evident. There was no difference in adverse events between groups.
                In this, the largest pre-cessation NRT trial to date, using NRT 2 weeks before the target quit day was safe and well tolerated but offered no benefit over usual care. However, in conjunction with previous pre-cessation trials there appears to be a moderate benefit, but not as large as that seen in most smaller trials. This multicenter, randomized, open-label clinical trial was conducted to determine whether the combined use of nicotine patch therapy and a nicotine nasal spray would improve smoking abstinence rates compared to either treatment alone, without behavioral counseling. Data were collected at 15 regional cancer control oncology centers within the North Central Cancer Treatment Group. Of the 1384 smokers randomized to the study, 20% were abstinent from smoking at 6 weeks and 8% were abstinent at 6 months. At 6 weeks, the 7-day point prevalence smoking abstinence rate for the patch alone (21.1%) was superior to the spray (13.6%) but was significantly lower than the rate for combination therapy (27.1%). At 6 months, the 7-day point prevalence abstinence rates were not significantly different among the three groups. Combination nicotine nasal spray and nicotine patches were delivered safely in a nonspecialized outpatient clinical setting and enhanced short-term smoking abstinence rates, but these rates were not sustained at 6 months. To compare the efficacy and safety of 22-mg and 44-mg doses of transdermal nicotine therapy when it is paired with minimal, individual, or group counseling to improve smoking cessation rates.
                An 8-week clinical trial (4 weeks double-blind followed by 4 weeks open label) using random assignment of participants to both dose (22 or 44 mg) and counseling (minimal, individual, or group) conditions.
                Daily cigarette smokers (> or = 15 cigarettes per day for at least 1 year) who volunteered to participate in a study of smoking cessation treatment. A total of 504 participants were enrolled at two sites.
                Four weeks of 22- or 44-mg transdermal nicotine therapy followed by 4 weeks of dosage reduction (2 weeks of 22 mg followed by 2 weeks of 11 mg). Counseling consisted of a self-help pamphlet (minimal); a self-help pamphlet, a brief physician motivational message, and three brief (< 15 minutes) follow-up visits with a nurse (individual); or the pamphlet, the motivational message, and eight weekly 1-hour group smoking cessation counseling visits (group). All participants returned weekly to turn in questionnaires and for assessment of their smoking status.
                Abstinence from smoking was based on self-report, confirmed by an expired carbon monoxide concentration lower than 10 ppm. Withdrawal severity was assessed by means of an eight-item self-report questionnaire completed daily.
                Smoking cessation rates for the two nicotine patch doses and three levels of counseling did not differ significantly at either 8 weeks or 26 weeks following the quit date. Among those receiving minimal contact, the 44-mg dose produced greater abstinence at 4 weeks than did the 22-mg dose (68% vs 45%; P < .01). Participants receiving minimal-contact adjuvant treatment were less likely to be abstinent at the end of 4 weeks than those receiving individual or group counseling (56% vs 67%; P < .05). The 44-mg dose decreased desire to smoke more than the 22-mg dose, but this effect was not related to success in quitting smoking. Transdermal nicotine therapy at doses of 44 mg produced a significantly greater frequency of nausea (28%), vomiting (10%), and erythema with edema at the patch site (30%) than did a 22-mg dose (10%, 2%, and 13%, respectively; P < .01 for each adverse effect). Three serious adverse events occurred during use of the 44-mg patch dose.
                There does not appear to be any general, sustained benefit of initiating transdermal nicotine therapy with a 44-mg patch dose or of providing intense adjuvant smoking cessation treatment. The two doses and all adjuvant treatments produced equivalent effects at the 26-week follow-up, and the higher patch dose produced more adverse effects. Higher-dose (44-mg) nicotine replacement does not appear to be indicated for general clinical populations, although it may provide short-term benefit to some smokers attempting to quit with minimal adjuvant treatment. The results are reported from a multicentered, randomized clinical trial of a physician-delivered smoking cessation intervention package. All physicians attended a four-hour training session during which the rationales for the different aspects of the intervention were discussed, including a detailed description of the proper use of nicotine-bearing chewing gum. Patients were randomized to receive an offer of a prescription of 2 mg of nicotine chewing gum in addition to the basic intervention (n = 111) or the basic intervention alone (n = 112). The basic intervention included advice, setting a date for quitting, self-help materials, and the offer of supportive follow-up visits. Receptionists were instructed to recruit the first two smokers attending the practice each day. One-year smoking cessation was validated by cotinine saliva analysis. The validated three-month sustained abstinence rates at one year were 8.1 percent and 9.8 percent in the gum and no-gum groups, respectively. The 95 percent confidence interval about this difference was -9.3 percent to 6.4 percent. There is no evidence from this study that the offer of 2 mg of nicotine-bearing gum enhances smoking cessation rates when added to a comprehensive intervention offered to all smokers in primary care. Until larger trials are completed, however, the possibility that this dose of nicotine gum may produce small beneficial effects cannot be excluded. To assess the smoking cessation efficacy of transdermal nicotine patches as an adjunct to low-intervention therapy, we conducted a double-blind, placebo-controlled trial in 158 smokers. Participants were randomly assigned to one of the following three study regimens that required daily application of two 15-cm2 patches: (1) 24-hour nicotine delivery, (2) nicotine delivery during wakeful hours only, and (3) placebo. The impact of the three regimens on smoking cessation rates and tobacco withdrawal symptoms was examined. During the last 2 weeks of the trial, 39% of the 24-hour nicotine regimen delivery group, 35% of those on wakeful hour nicotine regimens, and 13.5% of the placebo treatment group achieved abstinence. Self-reported quit rates for the two nicotine patch-wearing regimens, as compared with that for the placebo group, continued to be significantly higher at 6 months. Moreover, compared with placebo, the transdermal nicotine patches significantly reduced tobacco withdrawal symptoms during the first few weeks of quitting. The differences in quit rates and tobacco withdrawal symptoms between the two active groups were not statistically significant. The patches were well tolerated both topically and systemically. We concluded that transdermal nicotine, when used as an adjunct to low-intervention therapy, significantly reduced tobacco withdrawal symptoms and enhanced smoking cessation rates. Use of nicotine-replacement therapies and the antidepressant bupropion helps people stop smoking. We conducted a double-blind, placebo-controlled comparison of sustained-release bupropion (244 subjects), a nicotine patch (244 subjects), bupropion and a nicotine patch (245 subjects), and placebo (160 subjects) for smoking cessation. Smokers with clinical depression were excluded. Treatment consisted of nine weeks of bupropion (150 mg a day for the first three days, and then 150 mg twice daily) or placebo, as well as eight weeks of nicotine-patch therapy (21 mg per day during weeks 2 through 7, 14 mg per day during week 8, and 7 mg per day during week 9) or placebo. The target day for quitting smoking was usually day 8.
                The abstinence rates at 12 months were 15.6 percent in the placebo group, as compared with 16.4 percent in the nicotine-patch group, 30.3 percent in the bupropion group (P<0.001), and 35.5 percent in the group given bupropion and the nicotine patch (P<0.001). By week 7, subjects in the placebo group had gained an average of 2.1 kg, as compared with a gain of 1.6 kg in the nicotine-patch group, a gain of 1.7 kg in the bupropion group, and a gain of 1.1 kg in the combined-treatment group (P<0.05). Weight gain at seven weeks was significantly less in the combined-treatment group than in the bupropion group and the placebo group (P<0.05 for both comparisons). A total of 311 subjects (34.8 percent) discontinued one or both medications. Seventy-nine subjects stopped treatment because of adverse events: 6 in the placebo group (3.8 percent), 16 in the nicotine-patch group (6.6 percent), 29 in the bupropion group (11.9 percent), and 28 in the combined-treatment group (11.4 percent). The most common adverse events were insomnia and headache.
                Treatment with sustained-release bupropion alone or in combination with a nicotine patch resulted in significantly higher long-term rates of smoking cessation than use of either the nicotine patch alone or placebo. Abstinence rates were higher with combination therapy than with bupropion alone, but the difference was not statistically significant. nan To evaluate the smoking cessation efficacy of nicotine patch therapy as an adjunct to low-intensity, primary care intervention.
                Randomized, placebo-controlled, double-blind, multisite trial.
                Twenty-one primary care sites in Nebraska.
                A total of 369 smokers of 20 or more cigarettes per day.
                Two brief primary care visits for smoking intervention with 10 weeks of active or placebo-patch therapy.
                Confirmed self-reported abstinence 3, 6, and 12 months after the quit day.
                Compared with placebo control subjects, participants assigned nicotine patches had higher 3-month (23.4% vs 11.4%; P < .01) and 6-month (18.5% vs 10.3%; P < .05) abstinence rates. The 1-year abstinence rates for the active and placebo patch groups were 14.7% and 8.7%, respectively (P = .07). Of smokers aged 45 years and older, 9 (18.8%) of 48 using active patches compared with 0 of 31 using placebo patches achieved 12-month abstinence (chi 2 = 6.56; P < .05). Among those with high nicotine dependency scores (Fagerstrom score > or = 7), 1-year abstinence rates were significantly higher in the nicotine patch group (19.1%) compared with the placebo group (5.0%) (chi 2 = 10.7; P = .001). However, there was no significant difference in 1-year quit rates for participants with low Fagerstrom scores (< 7).
                Nicotine patch therapy enhanced 6 month quit rates as an adjunct to brief primary care intervention. The highest quit rates were achieved by participants who specifically contacted the site to enroll in the study or to obtain a prescription for nicotine patches. Differences in participant selection factors may account, in part, for the lower smoking cessation rates associated with primary care intervention. Duration of counseling, patient age, and Fagerstrom scores may be important factors related to the long-term smoking cessation success of nicotine patch therapy. Despite the well-documented efficacy and different pharmacokinetic and pharmacodynamic properties of different forms of nicotine replacement therapy, empirical data are insufficient to guide practitioners in selecting a particular form of treatment for individual patients with tobacco dependence.
                To evaluate the comparative efficacy of transdermal nicotine and nicotine nasal spray and identify predictors of treatment outcome.
                Randomized, open-label clinical trial with a 6-month follow-up period.
                2 university-based smoking cessation research programs.
                299 treatment-seeking smokers who were followed for 6 months after the target quit date.
                Behavioral group counseling and 8 weeks of therapy with nicotine nasal spray or transdermal nicotine.
                Demographic characteristics, smoking history, depression symptoms, and body mass index were measured at baseline. Smoking practices were biochemically verified at the end of treatment and at 6 months after the target quit date.
                Abstinence rates for the transdermal nicotine and nicotine nasal spray groups were not significantly different at 6-month follow-up (15.0% vs. 12.2%, respectively; P > 0.2). Interactions in abstinence rates for subgroups of smokers were statistically significant (P < 0.05). Smokers who had low to moderate dependence levels, were not obese, and were white achieved higher abstinence rates with transdermal nicotine, whereas smokers who were highly dependent, obese, or members of minority groups achieved higher abstinence rates with nasal spray.
                The subgroup findings need confirmation in additional large studies before they are routinely applied.
                Ethnicity, weight, and level of nicotine dependence may help identify smokers who have greater or lesser abstinence rates with either transdermal or nasal spray nicotine. Three hundred fifteen smokers who attended a family practice clinic and wished to quit smoking were assigned in a random, double-blind manner to receive either nicotine (2 mg) or placebo gum. Smokers initially received brief advice from a physician and nurse, a slide presentation and written materials (29 to 35 minutes), and a single follow-up visit (12 to 20 minutes) one week after cessation. After corrections for marital status and income, 10% of those who received nicotine gum and 7% of those who received placebo gum reported continuous abstinence for 11 months and passed observer and biochemical verification (this difference was not statistically significant). We conclude that, when used in a nonselected group of smokers along with a brief intervention in a general medical practice, the pharmacologic effects of nicotine gum to increase cessation are either small or nonexistent. To assess efficacy and tolerance of a transdermal nicotine system (TNS) as adjuvant to tobacco withdrawal, 112 young, nicotine-dependent cigarette smokers were treated for nine weeks with TNS (n = 56) or placebo (n = 56). Initial doses of nicotine (21 or 14 mg/24 h) were based on previous smoking habits and stepwise reduced to 7 mg/24 h if abstinence was achieved during medication. After treatment, 39.3% of the TNS users were abstinent versus 19.6% on placebo (p less than 0.05). The craving for cigarettes diminished steadily, but not more significantly on TNS medication. Tenseness, difficulty in concentration and feelings of hunger were consistently and in part significantly lessened in the TNS group. The other withdrawal symptoms were not influenced by TNS treatment. Nine-month follow-up cotinine-verified abstinence rates were 12.5% in the TNS and 3.6% in the placebo group (n. s.). Transient mild or moderate erythema at the application site appeared in 20% of the TNS and 6.3% of the placebo group, and 7.1% of the TNS users dropped out because of severe localized erythema. Other mild, transient, systemic side effects reported by 33.9% of the TNS and 26.8% of the placebo users (n. s.) did not lead to drop-outs. Nicotine replacement therapies are efficacious for treating nicotine dependence. However, limited data exist on benefits of different NRTs and predictors of treatment outcome. This study compared the effectiveness of transdermal nicotine vs. nicotine lozenge for smoking cessation and identified predictors of treatment response.
                A randomized, open-label effectiveness trial was conducted at 12 medical sites participating in the National Cancer Institute's Community Clinical Oncology Program. The sample consisted of 642 treatment-seeking smokers randomized to 12 weeks of transdermal nicotine or nicotine lozenge.
                Smoker characteristics were assessed at baseline, and 24-h point prevalence abstinence confirmed with breath carbon monoxide (CO) was evaluated at end of treatment (EOT) and at a 6-month follow-up. There was a trend for higher quit rates for transdermal nicotine vs. nicotine lozenge at EOT (24.3% vs. 18.7%, p=.10) and 6 months (15.6% vs. 10.9%, p=.10). A logistic regression model of EOT quit rates showed smokers who preferred transdermal nicotine, were not reactive to smoking cues, and did not use nicotine to alleviate distress or stimulate cognitive function had higher quit rates on transdermal nicotine. A logistic regression model of 6-month quit rates showed smokers who preferred transdermal nicotine had higher quit rates on transdermal nicotine, and smokers who used nicotine to alleviate distress or stimulate cognitive processes had lower quit rates on nicotine lozenge.
                Transdermal nicotine may be more effective than nicotine lozenge for smokers who prefer transdermal nicotine and do not smoke to alleviate emotional distress or stimulate cognitive function.
                Copyright 2009 Elsevier Ireland Ltd. All rights reserved. METHODS. One hundred six smokers seen in a family practice received brief physician advice and a prescription for nicotine gum. Smokers were randomly assigned to pay $20, $6, or $0/box of nicotine gum and followed for 6 months. RESULTS. Decreased cost increased the incidence of obtaining gum, the amount of gum used, and the incidence of long-term use (P less than 0.05). Decreased cost also increased cessation attempts and 1-week cessation (P less than 0.05) and appeared to increase abstinence at 6-month follow-up (19% vs 6% vs 8%, P less than 0.10). Cost-benefit estimates suggest that an insurance plan, HMO, etc., would recoup any costs in subsidizing nicotine gum and perhaps incur a net financial gain. Tobacco dependence is a chronic, relapsing condition that may require extended treatment.
                To assess whether extended-duration transdermal nicotine therapy increases abstinence from tobacco more than standard-duration therapy in adult smokers.
                Parallel randomized, placebo-controlled trial from September 2004 to February 2008. Participants and all research personnel except the database manager were blinded to randomization. (ClinicalTrials.gov registration number: NCT00364156)
                Academic center.
                568 adult smokers.
                In an unstratified small block-randomization scheme, participants were randomly assigned to standard therapy (Nicoderm CQ [GlaxoSmithKline, Research Triangle Park, North Carolina], 21 mg, for 8 weeks and placebo for 16 weeks) or extended therapy (Nicoderm CQ, 21 mg, for 24 weeks).
                The primary outcome was biochemically confirmed point-prevalence abstinence at weeks 24 and 52. Secondary outcomes were continuous and prolonged abstinence, lapse and recovery events, cost per additional quitter, and side effects and adherence.
                At week 24, extended therapy produced higher rates of point-prevalence abstinence (31.6% vs. 20.3%; odds ratio, 1.81 [95% CI, 1.23 to 2.66]; P = 0.002), prolonged abstinence (41.5% vs. 26.9%; odds ratio, 1.97 [CI, 1.38 to 2.82]; P = 0.001), and continuous abstinence (19.2% vs. 12.6%; odds ratio, 1.64 [CI, 1.04 to 2.60]; P = 0.032) versus standard therapy. Extended therapy reduced the risk for lapse (hazard ratio, 0.77 [CI, 0.63 to 0.95]; P = 0.013) and increased the chances of recovery from lapses (hazard ratio, 1.47 [CI, 1.17 to 1.84]; P = 0.001). Time to relapse was slower with extended versus standard therapy (hazard ratio, 0.50 [CI, 0.35 to 0.73]; P < 0.001). At week 52, extended therapy produced higher quit rates for prolonged abstinence only (P = 0.027). No differences in side effects and adverse events between groups were found at the extended-treatment assessment.
                The generalizability of the findings may be limited because participants were smokers without medical comorbid conditions who were seeking treatment, and differences in adherence across treatment groups were detected.
                Transdermal nicotine for 24 weeks increased biochemically confirmed point-prevalence abstinence and continuous abstinence at week 24, reduced the risk for smoking lapses, and increased the likelihood of recovery to abstinence after a lapse compared with 8 weeks of transdermal nicotine therapy.
                National Institutes of Health. Smoking is a major public health issue, estimated as causing 120 000 deaths in the UK per year. Smoking cessation is an important aspect of the treatment of many diseases. Nicotine replacement therapy (NRT) has been shown to increase cessation rates among healthy volunteers and in general practice, but it is not clear whether it has an effect in hospital patients.
                Patients referred by their hospital doctor to the smoking cessation counsellor and who agreed to participate in the study were randomised to receive either NRT given as a nicotine patch daily and a nicotine inhalator on an as needed basis plus advice and support (AS+NRT), or to receive just advice and support (AS). Claims of smoking cessation were validated at 1 week, 3 months, 6 months, and 1 year by carbon monoxide (CO) breath testing.
                A total of 245 patients were randomised, 136 AS+NRT and 109 AS. There were no significant demographic differences between the two groups at baseline. At 1 year 35 (14%) had sustained cessation confirmed by a CO breath test, 20/136 (15%) AS+NRT and 15/109 (14%) AS, p=0.857. One hundred and ten patients gave up smoking for at least 1 week, 54% AS+NRT and 33% AS (p<0.001). By 6 months there was no significant difference between the two groups (22/136 (16%) AS+NRT and 15/109 (14%) AS).
                In hospital patients NRT, given as regular daily patches plus an inhalator to be used as needed, did not add to the smoking cessation rate achieved at 1 year by regular advice and support, despite significantly increasing the cessation rate at 1 week. With smoking prevalence rates beginning to decline, studies designed to promote cessation in more challenging populations, like weight-concerned smokers, warrant attention. This study assessed the efficacy of two forms of pharmacotherapy [nicotine and phenylpropanolamine (PPA) gums] in addition to a 13-week cognitive behavioral smoking cessation program targeted for women. Participants were 439 females who met rigorous screening criteria and were randomized to one of the three treatment intervention groups (PPA gum, nicotine gum, or placebo gum). All participants attended a 13-week cognitive behavioral smoking cessation program and were given specific instructions on gum chewing. At posttest (13 weeks), and 6- and 12-month follow-ups, body weight and point prevalence abstinence were assessed. Analyses to determine potential differences between treatment groups on weight change and cessation rates were performed. Results indicated that neither change in body weight nor cessation rates significantly differed between groups. Attendance to sessions did appear to consistently increase the likelihood of quitting smoking at posttest and at each of the follow-ups. These results suggest that although the pharmacological interventions had no effect on cessation rates and postcessation weight gain, the behavioral component of the intervention was effective in increasing the odds of quitting smoking in weight-concerned women. Future efforts should focus on increasing adherence to behavioral program components, particularly session attendance. Nicotine replacement therapy is an effective treatment for nicotine-dependent smokers. However, cessation rates are modest, and preliminary studies suggest that combination therapy may be superior. We compared the efficacy of the nicotine inhaler plus nicotine patch vs nicotine inhaler plus placebo patch for smoking cessation.
                A double-blind, randomized, placebo-controlled trial was conducted in 400 subjects who had smoked 10 or more cigarettes per day for 3 years or longer. Group 1 (n = 200) received the nicotine inhaler plus nicotine patch (delivering 15 mg of nicotine per 16 hours) for 6 weeks, then inhaler plus placebo patch for 6 weeks, then inhaler alone for 14 weeks. Group 2 (n = 200) received the nicotine inhaler plus placebo patch for 12 weeks, then inhaler for 14 weeks. Inhaler was used at a rate of 6 to 12 cartridges per day ad libitum for 3 months and then tapered off. Main outcome measures were complete abstinence (self-reported) and expired carbon dioxide concentration less than 10 ppm.
                Group 1 vs group 2 complete abstinence rates were 60.5% and 47.5% at 6 weeks (P =.009), 42.0% and 31.0% at 12 weeks (P =.02), 25.0% and 22.5% at 6 months (P =.56), and 19.5% and 14.0% at 12 months (P =. 14). One-year survival analysis showed a significant association between abstinence and treatment with nicotine inhaler plus nicotine patch (P =.04). Mean nicotine substitution at week 6 was 60.1% (group 1) and 24.6% (group 2) (P<.001). At 12 months, the frequency of respiratory symptoms in abstinent subjects fell significantly and lung function showed a trend toward improvement. The most common adverse events were throat irritation (inhaler) and itching (patch).
                Treatment with the nicotine inhaler plus nicotine patch resulted in significantly higher cessation rates than inhaler plus placebo patch. In an additive design, test the efficacy of cue exposure treatment for smoking relapse prevention as an adjunct to current standard cognitive behavioral and pharmacological treatments.
                Randomized, controlled clinical trial.
                Outpatient behavioral medicine clinic.
                One hundred and twenty-nine cigarette smokers recruited through newspaper advertisements.
                After receiving an initial counseling session for cessation and setting a quit day, 129 smokers were randomly assigned to one of four relapse prevention treatment conditions: (1) brief cognitive behavioral; (2) cognitive behavioral and nicorette gum; (3) cognitive behavioral and cue exposure; and (4) cognitive behavioral and cue exposure with nicorette gum. All smokers met individually with their counselor for six RP sessions.
                Seven-day, point-prevalence abstinence rates (CO verified) taken at 1, 3, 6 and 12-months post-treatment and time to first slip.
                All manipulation checks and process measures suggested that the treatments were delivered as intended. There were no significant differences between conditions in point-prevalence abstinence rates or in time to first slip.
                These results call into question the utility of cue exposure treatment for smoking relapse prevention. The rate of smoking was significantly reduced in volunteer subjects by providing effective nicotine replacement, self-help material, and weekly visits with a nurse for 6 weeks. Nicotine-replacement therapy with a transdermal nicotine patch (Nicolan) almost doubled the 6-week smoking-cessation rate in comparison with that in a placebo group (77% versus 39%; P = 0.002) among subjects who were smoking at least 20 cigarettes per day at baseline. Although most subjects who used the active nicotine patches had skin reactions, the reactions were primarily mild. For use of both active and placebo patches, the level of patient compliance was high. Among subjects who continued to smoke, the use of cigarettes was decreased to less than 50% of the baseline smoking level in 7 of 7 with active nicotine patches and in 15 of 19 with placebo patches. Outcomes beyond 6 weeks showed a substantial relapse rate in both groups. Thus, when nicotine-replacement therapy is provided, a need exists for concurrent behavioral intervention and training for prevention of a relapse, neither of which was part of this protocol. To determine the efficacy of a 22-mg nicotine patch combined with the National Cancer Institute program for physician advice and nurse follow-up in providing withdrawal symptom relief, 1-year smoking cessation outcome, and percentage of nicotine replacement.
                Randomized, double-blind, placebo-controlled trial.
                Two-hundred forty healthy volunteers who were smoking at least 20 cigarettes per day.
                Based on the National Cancer Institute program, subjects received smoking cessation advice from a physician. Follow-up and relapse prevention were provided by a study nurse during individual counseling sessions. Subjects were randomly assigned to 8 weeks of a 22-mg nicotine or placebo patch.
                Abstinence from smoking was verified by expired air carbon monoxide levels. Withdrawal symptoms were recorded during patch therapy, and the percentage of nicotine replacement was calculated by dividing serum nicotine and cotinine levels at week 8 of patch therapy by levels obtained while smoking.
                Higher smoking cessation rates were observed in the active nicotine patch group at 8 weeks (46.7% vs 20%) (P < .001) and at 1 year (27.5% vs 14.2%) (P = .011). Higher smoking cessation rates were also observed in subjects assigned to the active patch who had lower serum levels of nicotine and cotinine at baseline, and withdrawal symptom relief was better in the active patch group compared with placebo.
                Clinically significant smoking cessation can be achieved using nicotine patch therapy combined with physician intervention, nurse counseling, follow-up, and relapse prevention. Smokers with lower baseline nicotine and cotinine levels had better cessation rates, which provides indirect evidence that they had more adequate nicotine replacement with this fixed dose of transdermal nicotine than those smokers with higher baseline levels. This study investigated the effect of matching smokers to nicotine replacement therapy (nicotine gum) on the basis of the pretreatment level of nicotine dependence.
                One hundred seventy-three smokers, classified as high or low on nicotine dependence using the Fagerstrom Tolerance Questionnaire, were assigned at random to receive nicotine gum (2 mg), chewed ad libitum, or to not receive nicotine gum. All smokers participated concurrently in a 5-week treatment program consisting of four brief counseling sessions combined with a self-help manual provided by the American Lung Association.
                Results showed that smokers with high levels of nicotine dependence were significantly more likely to quit smoking during treatment if they received nicotine gum (31.9%) than high-dependence smokers who did not receive the gum (12.2%). There was a tendency for smokers with low levels of nicotine dependence to do worse during treatment if they received gum (13.5% quit) than they did when they received no gum (20% quit), although this difference was not statistically significant. The relative differences in outcomes persisted after 1 year of follow-up, but the high overall rate of relapse (92.5%) rendered the absolute size of the differences statistically insignificant.
                The results of the study are discussed in terms of strategies that might improve the success of treatment-matching approaches with newer forms of nicotine replacement therapies. To evaluate the efficacy of the transdermal nicotine patch as an aid to smoking cessation when used as an adjunct to a cognitive-behavioural group intervention and to assess the effectiveness of the patch in ameliorating withdrawal symptoms.
                Double-blind placebo-controlled randomised trial with six months' follow-up of those who returned to the hospital-based outpatients smoking cessation clinic.
                Three hundred and thirteen smokers recruited from the local community. Mean age was 42 years, 48% were male, mean cigarette consumption was 29 per day and mean duration of smoking was 24 years.
                Cognitive-behavioural intervention delivered in a group context, two hours once a week over five weeks, self-help manual, and 24-hour daily nicotine patch treatment for 10 weeks.
                Point prevalence abstinence at three and six months, and sustained cessation from end of treatment to six months, with biochemical validation (expired carbon monoxide). We examined the effectiveness of the nicotine patch in ameliorating specific withdrawal symptoms by self-report of degree of severity.
                The active nicotine patch resulted in significantly higher biochemically confirmed abstinence rates when compared with placebo at three months (48% v. 21%) and at six months (33% v. 14%). Six-months' continuous abstinence rates were also significantly higher among the active nicotine group (25%) compared with placebo (12%). The most common adverse events among active patch users were sleep disturbance and local skin irritation. The nicotine patch reduced the severity of some withdrawal symptoms. A low level of dependence was the strongest predictor of three and six months' abstinence.
                The transdermal nicotine patch is effective when used as an adjunct to a group cognitive-behavioural intervention and it provides relief from withdrawal symptoms associated with nicotine dependence. Three smoking cessation interventions designed for use by general practitioners (GPs) within the routine consultation were evaluated in a field setting using 26 GPs throughout metropolitan Sydney. A total of 450 smoking patients were allocated to either Structured Behavioral Change with nicotine gum (Group SBCN), Structured Behavioral Change without nicotine gum (Group SBC), or GP advice with nicotine gum (Group AN). Although significant differences in the percentage of abstainers were observed between Groups SBCN and SBC three weeks after treatment (39% vs. 26%), the point prevalence abstinence rate for patients at 12 months declined to 19, 18, and 12% for Groups SBCN, SBC, and AN, respectively. Continuous abstinence to the end of the 12-month period was 9% for Groups SBCN and SBC, and 6% for Group AN. Forty-eight percent of the 450 patients made an attempt to stop smoking, and 89% reduced their cigarette consumption at some point during the study. Examination of 132 self-selecting patients who fully participated in the three interventions and attended all scheduled visits, revealed significantly larger proportions of abstainers within Groups SBCN (34%) and SBC (33%) than in Group AN (15%) at the 12-month follow-up. Guidelines recommend that smoking cessation interventions are offered in all clinical settings to all smokers willing to make a quit attempt. Since the effectiveness of routine provision of behavioural counselling and nicotine replacement therapy (NRT) to smokers admitted to hospital has not been established, a randomised controlled trial of these interventions given together compared with counselling alone or minimal intervention was performed in hospital inpatients.
                Medical and surgical inpatients who were current smokers at the time of admission were randomised to receive either usual care (no additional advice at admission), counselling alone (20 minute intervention with written materials), or NRT plus counselling (counselling intervention with a 6 week course of NRT). Continuous and point prevalence abstinence from smoking (validated by exhaled carbon monoxide <10 ppm) was measured at discharge from hospital and at 3 and 12 months, and self-reported reduction in cigarette consumption in smokers was assessed at 3 and 12 months.
                274 inpatient smokers were enrolled. Abstinence was higher in the NRT plus counselling group (n=91) than in the counselling alone (n=91) or usual care (n=92) groups. The difference between the groups was significant for validated point prevalence abstinence at discharge (55%, 43%, 37% respectively, p=0.045) and at 12 months (17%, 6%, 8%, p=0.03). The respective differences in continuous validated abstinence at 12 months were 11%, 4%, 8% (p=0.25). There was no significant difference between counselling alone and usual care, or in reduction in cigarette consumption between the treatment groups.
                NRT given with brief counselling to hospital inpatients is an effective routine smoking cessation intervention. Smoking cessation is an arduous process because nicotine withdrawal syndrome, which occurs following sudden interruption of nicotine use in long-term smokers, frequently prevents them from giving up the habit. Nicotine supplement systems may relieve smokers' nicotine withdrawal symptoms and, thus, help in the process of abstinence from smoking. The purpose of the present study was to investigate the effectiveness and safety of a 30-mg transdermal nicotine patch in a smoking cessation program for Chinese smokers. In this randomized, double-blind, placebo-controlled study, 30 heavy smokers, who had smoked more than 20 cigarettes per day for more than a year, were treated with 30-mg transdermal nicotine patches, and 32 heavy smokers were given placebo patches during a 6-week smoking cessation program. The clinical characteristics of the two groups were similar. After 6 weeks, the use of the transdermal nicotine patch was associated with markedly reduced nicotine dependence and severity of withdrawal symptoms. Nineteen (63%, 95% confidence interval, CI, 46%-80%) of the smokers treated with the transdermal nicotine patch had successfully quit smoking at the end of the program (6 weeks) and nine (30%, 95% CI 14%-46%) remained abstinent 1 year later. In contrast, only 11 (34%, 95% CI 18%-50%) of the smokers in the placebo group had successfully stopped smoking after 6 weeks, and three remained abstinent 1 year later (9%, 95% CI 0%-19%). However, there was no statistically significant difference between the two groups of smokers after 1 year of follow-up (p = 0.08). Side-effects were minimal and did not affect the efficacy of the skin patch. The results indicate that the transdermal nicotine patch is an effective aid in smoking cessation programs. Medical advice and use of nicotine gum have recently received increased attention as effective tools to encourage smokers to quit, yet the relative value of nurse vs physician counseling has not been explored in depth. In this study, 425 smokers attending three urban primary care centers in Barcelona were systematically allocated to one of three groups: group A patients received a brief counseling session to quit from their family physician; group B patients were given the same brief counseling along with a free supply of nicotine gum; group C received a brief health-education session from the primary care nurse. Three hundred forty-nine patients (82%) could be reached by telephone at the two-month follow up. By that time, after correcting for the estimated validity of the phone report of smoking status, the proportion declaring themselves to be nonsmokers was 10.9%, 11.1%, and 10.8%, respectively, without significant differences between them. At one-year follow up the proportions were 4.4%, 5.3%, and 6.0%. In the logistic regression analysis, only the expected difficulty of quitting was predictive of one-year abstention, OR = 3.1 (95% CI: 1.3-7.3). The present study shows no difference between physician versus nurse counseling and no improvement in the proportion of quitters with the addition of nicotine gum in the physician-counseled group. The results after 6 months of the treatment of three intervention groups with nicotine chewing gum to evaluate its effectiveness for the treatment of smoking addiction in primary care are reported. After random allocation, 106 individuals out of the 200 recruited in three health centers started the treatment. The active group (n = 37), treated with group sessions and nicotine chewing gum, was compared with a placebo group (n = 38) with an identical intervention. The success rate was 35.1 in the first group and 13.2 in the second (p less than 0.03), thus confirming the effectiveness of nicotine chewing gum. A third group, called consulting room group, (n = 31) was treated with nicotine chewing gum and follow up in the programmed usual consulting room. The rate of success in this group was 25.8%, without statistically significant difference with the first group. Weight gain after smoking cessation is often cited by women smokers as a primary reason for not attempting to quit smoking or for relapsing after a cessation attempt.
                A randomized trial of 417 women smokers was conducted to test the addition of two weight control strategies to a smoking cessation program. Participants received the standard smoking cessation program, the program plus nicotine gum, the program plus behavioral weight control, or the program plus both nicotine gum and behavioral weight control. Weight and smoking status were measured at the end of treatment and at 6 and 12 months posttreatment.
                Smoking cessation rates were highest in the group receiving the smoking cessation program plus nicotine gum. Weight gain did not vary by treatment condition, so its effect on relapse could not be examined by group. There was no significant relationship between weight gained and relapse in individuals.
                The added behavioral weight control program was attractive to the participants and did not reduce smoking cessation rates. However, it did not produce the expected effect on weight, thereby restricting our ability to examine the effect of weight control on smoking cessation and relapse. The effects of nicotine (NI), silver acetate (SA), and ordinary (PL) chewing gum on the cessation of smoking were compared through ratings on six smoking types and physiological nicotine dependence (F-score) in a placebo-controlled and randomized study that included 496 smokers in a group-support setting. Results were evaluated after 26 weeks. Ratings on smoking types 1, 3, 4, 5, and 6 and F-score were related to success rates. The effect of NI was superior to SA in smokers with high type 1 ratings, the effects of NI and SA were almost equal and superior to PL in smokers with high type 4 and 6 ratings, and the effect was independent of the F-score. Treatment of smokers with NI and SA should be restricted to smoking types in which an effect superior to PL is documented, and research should be performed to find support for smoking types where SA and NI have a clear effect. The objective of the study was to evaluate the therapeutic efficacy of nicotine nasal solution (NNS) for smoking cessation from the stopping day up to 3 months. We also followed the participants for 2 yrs after ceasing smoking to assess what happens after stopping using NNS. In a placebo-controlled, double-blind, 2 yr prospective study, 157 smokers were given either NNS, one dose containing 1 mg of nicotine per 100 microL (n=79), or placebo (n=78). Treatment was continued for up to 1 yr. One day after quitting smoking, the average number of daily doses was 11 in the group assigned NNS and 14 in the group assigned the placebo, and after 6 weeks, 14 and 6 doses, respectively, among abstinent participants still using spray. After 3 months, 65% of the abstainers in the nicotine group were still using the NNS. The abstinence rates were 51, 39 and 29% after 6 weeks, 3 and 6 months, respectively, as compared to 24, 19 and 18% in the placebo group (p=0.0003; p=0.003; p=0.050). The proportion abstinent at the 1 yr (25 vs 17%) and 2 yr follow-ups (19 vs 14%) was higher among those assigned to the nicotine than to the placebo group, but not significantly so for the numbers used in the study. In conclusion, the use of nicotine nasal spray significantly increased the abstinence rate during the first 6 months following the quitting day. To evaluate the efficacy of using a nicotine patch for 5 months with a nicotine nasal spray for 1 year.
                Placebo controlled, double blind trial.
                Reykjavik health centre.
                237 smokers aged 22-66 years living in or around Reykjavik.
                Nicotine patch for 5 months with nicotine nasal spray for 1 year (n=118) or nicotine patch with placebo spray (n=119). Treatment with patches included 15 mg of nicotine for 3 months, 10 mg for the fourth month, and 5 mg for the fifth month, whereas nicotine in the nasal spray was available for up to 1 year. Both groups received supportive treatment.
                Sustained abstinence from smoking.
                Sustained abstinence rates for the patch and nasal spray group and patch only group were 51% v 35% after 6 weeks (odds ratio 1.97, 95% confidence interval 1.17% to 3.32; P=0.011(chi2), 37% v 25% after 3 months (1.76, 1.01 to 3.08; P=0.045), 31% v 16% after 6 months (2.40, 1.27 to 4.50; P=0.005), 27% v 11% after 12 months (3.03, 1.50 to 6.14; P=0.001), and 16% v 9% after 6 years (2.09, 0.93 to 4.72; P=0.08) [corrected].
                Short and long term abstinence rates show that the combination of using a nicotine patch for 5 months with a nicotine nasal spray for 1 year is a more effective method of stopping smoking than using a patch only. The low percentage of participants using the nasal spray at 1 year, and the few relapses during the second year, suggest that it is not cost effective to use a nasal spray for longer than 7 months after stopping a patch. Sixty subjects were run in a study comparing the use of nicotine gum with placebo gum during cessation from smoking. Subjects were given clinic support and chewed the gum ad libitum. A survival analysis showed the two groups differed significantly in successful abstinence over time (p less than .03). Differences between groups appeared early (within weeks) and, at six months, a 28% superiority of nicotine over placebo gum was demonstrated with mean success rates of 48% and 20%, respectively. Between six months and one year, relapse in the nicotine group accounted for the 30% vs. 20% success rates for nicotine and placebo observed at one year. In a pilot study ("dispensary") testing the efficacy of the two gums when intervention was minimal, subjects in both groups resumed smoking within the first two weeks. The enhanced short-term success rates with nicotine gum in the clinic study are attributed to an effective interaction between use of the active preparation and clinic support. Long-term cessation may require extended maintenance procedures and/or an identification of optimal gum use. The primary aim was to compare the efficacy of smoking cessation treatment using a combination of active nicotine patch plus active nicotine gum versus therapy consisting of active nicotine patch plus placebo gum in a sample of alcohol-dependent tobacco smokers in an early phase of out-patient alcohol treatment. A secondary aim was to determine whether or not there were any carry-over effects of combination nicotine replacement on drinking outcomes.
                Small-scale randomized double-blind placebo-controlled clinical trial with 1-year smoking and drinking outcome assessment.
                Two out-patient substance abuse clinics provided a treatment platform of behavioral alcohol and smoking treatment delivered in 3 months of weekly sessions followed by three monthly booster sessions.
                Participants were 96 men and women with a diagnosis of alcohol abuse or dependence and smoking 15 or more cigarettes per day.
                All participants received open-label transdermal nicotine patches and were randomized to receive either 2 mg nicotine gum or placebo gum under double-blind conditions.
                Analysis of 1-year follow-up data revealed that patients receiving nicotine patch plus active gum had better smoking outcomes than those receiving patch plus placebo gum on measures of time to smoking relapse and prolonged abstinence at 12 months. Alcohol outcomes were not significantly different across medication conditions.
                Results of this study were consistent with results of larger trials of smokers without alcohol problems, showing that combination therapy (nicotine patch plus gum) is more effective than monotherapy (nicotine patch) for smoking cessation. The effect of different follow-up programs reinforced or not reinforced with the nicotine chewing gum Nicorette was tested by 13 physicians working in the open health care system. A total of 151 patients were advised to stop smoking, and were asked to participate in the program if judged sufficiently motivated by the physicians. After inclusion they were randomized into short or long follow-up, and nicotine gum vs no gum. The physicians conducted the follow-up therapy in their own personal way. Short follow-up was comprised of one appointment 14 days after cessation, while long follow-up consisted of a telephone call (1 week), an appointment (2 weeks), a second appointment (1 month), and a letter (3 months). The results at 12 months were that long follow-up showed a trend (P less than 0.12 toward being better than short follow-up, while nicotine gum was significantly better than no gum (P less than 0.05) in maintaining abstinence. The group with the best outcome was the one receiving long follow-up and nicotine gum, which yielded an expired air carbon monoxide-controlled, 12-month abstinence rate of 27%. The abstinence outcomes at 12 months for the other groups were short follow-up and nicotine gum, 22%; long follow-up and no gum, 15%; and short follow-up and no gum, 3%. The physicians' reactions to the smoking cessation treatment were largely positive. The nicotine gum seems to be a relatively simple, cost-effective, and practical tool for physicians to enhance and reinforce their antismoking advice. With a longer active follow-up period than was used here (1 month), even better results may be possible. Two hundred smokers who were judged by their general practitioner to be motivated to stop smoking were allocated to one of two groups. All were offered an initial appointment at which they were advised to stop smoking and offered nicotine gum. One group then received no further appointments. The other was offered four further appointments over three months. Both groups were followed up at six and 12 months. At one year follow up 15.5% overall had stopped smoking, 14% in the low and 17% in the high contact group. This is better than most results so far reported for nicotine chewing gum in general practice, suggesting that general practitioners can use it to good effect. We compare this result with others achieved in general practice. A nicotine mouth spray has advantages over other acute forms of nicotine replacement therapy, such as a faster uptake of nicotine and faster relief of craving. This multicentre, randomised (2:1), double-blind, placebo-controlled efficacy and safety study evaluated self-reported, carbon monoxide-verified continuous abstinence from smoking from week 2 until weeks 6, 24, and 52 in 479 smokers (≥ 1 cigarette per day) who were treated with either active (n=318) or placebo (n=161) spray for 12 weeks and low-intensity counselling at three smoking cessation clinics in Denmark and Germany. Active treatment yielded significantly higher continuous abstinence rates than placebo from week 2 until week 6 (26.1% versus 16.1%; relative success rate (RR) 1.62, 95% CI 1.09-2.41), week 24 (15.7% versus 6.8%; RR 2.30, 95% CI 1.23-4.30), and week 52 (13.8% versus 5.6%; RR 2.48, 95% CI 1.24-4.94). Most adverse events were mild to moderate, and 9.1% of subjects on active spray withdrew due to adverse events, compared to 7.5% on placebo. The overall rate of treatment-related adverse events was 87.4% with active spray versus 71.4% with placebo spray. Nicotine mouth spray delivered significantly higher 6-, 24- and 52-week continuous abstinence rates than placebo. A double-blind trial of a smoking-withdrawal chewing gum containing 2 mg nicotine was conducted with 100 consecutive patients in a smoking cessation clinic. All patients received the usual psychological treatment given at the clinic. In addition, the patients were randomly assigned to a nicotine gum (the experimental group) or a placebo chewing gum (control group). The abstinence rates for the experimental group at 1, 3, and 6 months after quitting were 90, 76, and 63%, respectively. The comparable abstinence rates for the control group were 60, 52, and 45%. The differences were significant at the 5% level at all three follow-up periods. When nicotine dependence, as measured by a standard questionnaire, was taken into consideration, it was found that 71% of the high-nicotine-dependent smokers in the experimental group were abstinent after 6 months, as compared to 39% in the placebo group. In contrast, low-nicotine-dependent patients achieved 75 and 65%, respectively, for the same time interval. The gum was well accepted by patients and gave no serious side effects. Nicotine replacement by transdermal patches is more effective than placebo in smoking cessation, but has a low success rate after one year (9-18%). We tested whether this was attributed to insufficient nicotine replacement. We conducted a randomized trial to investigate the effect on outcome of different doses of transdermal nicotine replacement after stratification according to baseline plasma cotinine values. Two hundred and ninety seven adult smokers were enrolled. Those with baseline cotinine < or = 250 ng.ml-1 (low cotinine) were randomly assigned to placebo (LC-P) or to 15 mg 16 h nicotine patches (LC-15), and those with baseline cotinine > 250 ng.mL-1 (high cotinine) were randomly assigned to 15 mg (HC-15) or 25 mg (HC-25) 16 h nicotine patches. Plasma nicotine and cotinine values, expired carbon monoxide and withdrawal symptoms were measured at scheduled intervals during treatment. Smokers in the LC-15 group had a significantly higher success rate than placebo (28 vs 9%). Smokers with high baseline cotinine had lower success rates, and a high dose of nicotine did not increase success rate (HC-25 9% vs HC-15 11%). Subjects in the HC-15 group had the lowest percentage of nicotine replacement and a higher prevalence of withdrawal symptoms than the HC-25 group. Replacement was similar in groups LC-15 and HC-25, but the success rate was significantly lower in HC-25 group, despite similar levels of withdrawal symptoms. We conclude that a higher success rate was obtained after one year in smokers with low baseline plasma cotinine values. Determination of plasma cotinine values may be, thus, helpful in identifying smokers who could benefit from transdermal nicotine replacement. A study with a 2 x 2 factorial design was performed to evaluate the effectiveness of acupuncture, of nicotine gum and the effect of the association on smoking cessation. After a one-year follow-up period, the success rates were in the same order of magnitude for nicotine gum (active treatment: 10%, placebo: 8%) group and for acupuncture (active treatment: 8%, placebo: 10%) group. To assess the effect of nicotine patches on continine-validated smoking cessation in pregnant women and the effect of nicotine on birth weight and preterm delivery.
                Pregnant women who smoked ten or more cigarettes after the first trimester (N = 250) were randomly assigned to receive nicotine patches (n = 124) or placebo patches (n = 126). Women randomized to nicotine were treated with 15-mg patches (16 hours/day) for 8 weeks, and 10-mg patches (16 hours/day) for 3 weeks.
                Overall, 26% stopped smoking and 14% were nonsmokers 1 year after delivery. There was no difference between nicotine and placebo groups. At the end of the intervention, the mean value of cotinine in saliva in women assigned to nicotine was 120 ng/mL and placebo 153 ng/mL (mean difference -33; 95% CI -72, 6 ng/mL). Mean birth weight difference was 186 g (95% CI 35, 336 g) higher in the nicotine than placebo group, and there was an insignificantly lower rate of low birth weight (under 2500 g) in the former group. There was no difference in the rate of preterm delivery between the two groups.
                Nicotine patches had no influence on smoking cessation during pregnancy, although they might increase birth weight in comparison with placebo. Eighty-nine smokers were randomly assigned to four nicotine gum treatments for smoking cessation: behavioral treatment plus a fixed schedule of nicotine gum, behavioral treatment plus an ad lib schedule, education plus a fixed schedule, and education plus an ad lib schedule. The four treatment conditions produced similar rates of abstinence (40.9% to 58.3%) at the end of 11 weeks of treatment. However, at 6-month follow-up, the subjects who had received behavioral treatment had a significantly better abstinence rate (36.7%) than those receiving education (17.5%). Nicotine gum schedule had no effect on treatment outcome. Smoking cessation is a key intervention for prevention of several lung diseases. The aim of the present study was to compare the effect of smoking cessation with nicotine replacement in a lung clinic in a low resource set-up suitable for implementation in other lung clinics. This was an open, randomized trial with 4 different nicotine replacement regimes combined with minimal behavioural support in daily routine. A total of 446 smokers (>9 cigarettes x day(-1)) were allocated to a nurse-conducted smoking cessation programme with 4 treatment arms: a 5-mg nicotine patch ("placebo"), a 15-mg nicotine patch, nicotine inhaler, and a 15-mg nicotine patch plus nicotine inhaler. Recommended use of the nicotine products were 3 months with the possibility of continuing use up to 9 months on an individual basis. Individual follow-up studies were scheduled after 2 and 6 weeks, 3, 6, 9 and 12 months. The 12-month point prevalence was 6% (5-mg patch (placebo)), 16% (15-mg patch) (p<0.05), 9% (inhaler) and 11% (15-mg patch plus inhaler), respectively. To conclude, the set-up investigated in this study which included minimal behavioural support with nicotine patches should be evaluated in other lung clinics, as it doubled success rate when compared to a placebo with a 1-yr point prevalence of 16% and also the resources used are limited. To determine the efficacy of the transdermal nicotine patch for smoking cessation in inner-city African Americans.
                Double-blind, placebo-controlled, randomized trial.
                Outpatient in an inner-city hospital.
                A computer-generated random numbers table with a block size set at 20 was used to randomize 410 patients to one of two study arms.
                The transdermal nicotine patch for 10 weeks as an adjunct to brief counseling.
                Of the 410 patients randomized, mean age was 48 years, 65% were female, 41% had less than a high school education, 51% had an annual household income of less than $8,000, and the average number of cigarettes smoked per day was 20. Quit rates at 10 weeks were 21.5% (44/205) with the nicotine patch, and 13.7% (28/205) with the placebo patch (p = .03). At 6 months, quit rates were 17.1% (35/205) with the nicotine patch, and 11.7% (24/205) with the placebo patch (p = .08). After adjusting for baseline differences in age and educational attainment, differences remained significant at 10 weeks (p = .04), but were not significant at 6 months (p = .14). Compliance rates for return visits were 83%, 78%, 55%, and 52%, at 1, 2, 6, and 10 weeks, respectively.
                The nicotine patch significantly improves short-term quit rates in inner-city African Americans who are interested in trying to quit smoking. Efforts should be made to reach underserved populations through smoking cessation programs, and to assist in maintaining abstinence. Few studies have examined the effect of nicotine replacement therapy (NRT) in COPD patients.
                To evaluate the efficacy of nicotine sublingual tablets and two levels of support for smoking cessation in COPD patients.
                Double-blind, multicenter, placebo-controlled smoking cessation trial.
                Pulmonary outpatient clinics.
                Three hundred seventy COPD patients who smoked a mean of 19.6 cigarettes per day (mean, 42.7 pack-years; mean FEV(1), 56% of predicted).
                Nicotine sublingual tablet or placebo for 12 weeks combined with either low support (four visits plus six telephone calls) or high support (seven visits plus five telephone calls) provided by nurses.
                Carbon monoxide-verified abstinence rates and St. George Respiratory Questionnaire (SGRQ) assessed at 6 months and 12 months.
                Two hundred eighty-eight of 370 patients were evaluable for the final study end points. Smoking cessation rates were statistically significantly superior with sublingual nicotine vs placebo for all measures of abstinence: 6-month point prevalence, 23% vs 10%; 12-month point prevalence, 17% vs 10%. There was no significant difference in effect between low vs high behavioral support. The SGRQ score improved significantly in abstainers vs nonabstainers; the changes in mean scores were -10.9 vs - 2.9 for total score, and - 28.6 vs - 2.3 for symptom score, respectively.
                This trial demonstrated the long-term efficacy of NRT for cessation for the general population of COPD smokers, regardless of daily cigarette consumption. Cessation success rates were in the same range as in healthy smokers, and abstinence improved SGRQ scores. NRT should be used to aid cessation in all smokers with COPD, regardless of disease severity and number of cigarettes smoked. Many smokers express a desire to quit smoking by gradually reducing the number of cigarettes they smoke until they stop completely. This study tested the efficacy of nicotine gum in facilitating cessation through gradual reduction.
                This was a multi-center, placebo-controlled, double-blind RCT of 2- and 4-mg nicotine gum versus placebo.
                3297 smokers who were interested in quitting gradually.
                Subjects were instructed to gradually reduce their smoking while increasing their gum use over the course of up to 8 weeks. Once they had achieved initial abstinence (no smoking for 24 hours), gum was to be used in accordance with the current FDA-approved directions for cessation. The study was conducted under over-the-counter conditions, with no counseling provided. Continuous abstinence was assessed after 28 days and 6 months. Secondary measures of smoking reduction were also assessed. Analyses were conducted in 1999-2000 and 2007-2008.
                Smokers on active gum were significantly more likely to achieve initial cessation (2 mg: OR=1.42; 4 mg: OR=1.90); 28-day continuous abstinence (2 mg: OR=2.01; 4 mg: OR=4.66); and continuous abstinence at 6 months (2 mg: OR=1.80; 4 mg: OR=5.96). During the reduction phase, active gum aided smoking reduction, and participants who reduced their smoking were more likely to achieve abstinence.
                These findings demonstrate that smokers who wish to quit smoking by gradual reduction can increase their success by using nicotine gum to facilitate reduction and cessation. Most smoking cessation programs advise abrupt rather than gradual cessation. We conducted a randomized, controlled trial of gradual cessation (n=297) vs. abrupt cessation (n=299) vs. minimal treatment (n=150) among smokers who wanted to quit now and preferred to quit gradually. Participants were recruited via newspaper and radio advertisements. The gradual and abrupt conditions received five phone calls (total=90 min) and the minimal treatment condition received two calls (25 min total). The gradual condition received nicotine lozenge (via mail) to reduce smoking prior to their quit date. After the quit day, all participants received lozenge. The primary outcome was prolonged abstinence from 2 weeks post-quit day through 6 months. Prior to the quit day, the gradual condition decreased cigarettes/day by 54%, whereas the other two conditions decreased by 1% and 5%. Prolonged abstinence rates (CO<10 ppm) did not differ among gradual, abrupt and minimal treatment conditions (4%, 7% and 5%), nor did 7-day point prevalence rates (7%, 11% and 11%). Fewer smokers in the gradual condition (48%) made a quit attempt than in the abrupt (64%) or minimal (60%) conditions (p<.001). In the gradual condition, every week delay to the quit date increased the probability of lapsing by 19% (p<.001). We conclude that among smokers who want to stop gradually in the near future, gradual cessation with nicotine pre-treatment does not produce higher quit rates than abrupt cessation. One liability of gradual reduction may be that it allows smokers to delay their quit date.
                Copyright 2010 Elsevier Ireland Ltd. All rights reserved. Heavy smokers (N = 408, smoking more than 25 cigarettes/day) were randomized to receive high-dose (25 mg) or standard-dose (15 mg) nicotine patch therapy delivered during the daytime only (16 hr) for a period of 6 weeks. Treatment effects of each dose were similar. The percentages of participants not smoking at 2-, 6-, and 12-month follow-ups were 26 versus 20, 14 versus 16, and 14 versus 14 for the 15-mg and 25-mg doses, respectively. The higher dose was well tolerated, and adverse event profiles for both treatment doses were very similar. Stepwise Cox proportional hazards analyses indicated that initial postrandomization craving and baseline scores on the Center for Epidemiological Studies Depression Instrument predicted time-to-relapse during treatment; only initial craving predicted relapse over the entire study interval (12 months). The results of this trial do not support the routine use of higher dose nicotine patch therapy in the treatment of nicotine dependence. This study reports findings from an investigation of the efficacy of high-dose nicotine patch (NP) therapy for heavy smokers with a history of alcohol dependence. One hundred thirty participants were randomly assigned to 42 or 21 mg of transdermal nicotine. Follow-up assessments were conducted at 4, 12, 24, and 36 weeks. Differences between dose conditions were nonsignificant, although, unexpectedly, outcomes favored participants in the 21-mg NP condition. Nicotine abstinence rates in the 21- and 42-mg NP conditions on Week 36 follow-up were 16.9% and 9.2%, respectively. Patch condition did not interact with severity of nicotine dependence. However, nicotine abstinence at follow-up was related to a longer length of alcohol abstinence. No evidence was found for better outcomes as a function of the percentage of baseline cotinine replaced by NPs. Future research should focus primarily on investigating ways to improve smoking quit rates for smokers in early alcohol recovery. The process and outcome of a smoking cessation program using behavior therapy alone (BT) or behavior therapy plus the nicotine patch (BTP) was studied in 64 participants. Participants quit smoking on a target date after a period of ad libitum smoking, cognitive-behavior therapy preparing them for cessation, and behavioral rehearsal for high-risk situations, including stress management, and coping with negative affect. Abstinence was significantly higher for the BTP group versus the BT group from the end of behavioral treatment (79% vs. 63%) through the 3-month follow-up (p < .01), with the effects weakening at the 6- (p = .06) and 12-month marks (p = 38% vs. 22%). More general distress was observed among BT versus BTP participants (i.e., increased withdrawal, tension, fatigue, and coping frequency with decreased coping effort; coping-to-urge ratio). The coping behavior of the BTP group may have been more effective than that of the BT group, as indicated by their significantly higher level of self-efficacy. To assess the effectiveness of transdermal nicotine therapy for smoking cessation and suppression of withdrawal severity in conjunction with two different adjuvant counseling treatments.
                Two independent randomized placebo-controlled double-blind trials.
                Smoking cessation clinic.
                Eighty-eight (study 1) and 112 (study 2) adult volunteers motivated to quit smoking.
                Eight weeks of 22-mg transdermal nicotine therapy with group counseling (study 1); 4 weeks of 22 mg followed by 2 weeks of 11-mg transdermal nicotine therapy with brief individual counseling (study 2).
                Modified point prevalence (7 consecutive days of nonsmoking) at the end of patch treatment and 6 months after treatment initiation was assessed by self-report and biochemically confirmed; survival analyses were also conducted for both studies to compare treatment efficacy. Also, we examined the impact of the nicotine patch on specific withdrawal symptoms (anger, anxiety, awakening, difficulty concentrating, depression, hunger, impatience, and craving).
                Transdermal nicotine treatment produced higher cessation rates at the end of treatment than did placebo with both adjuvant counseling interventions: 59 percent vs 40 percent (p < 0.05 in study 1) and 37 percent vs 20 percent (p < 0.05 in study 2), respectively. Smoking cessation efficacy was maintained 6 months after initiation of treatment: 34 percent vs 21 percent (p = 0.08 in study 1) and 18 percent vs 7 percent (p = 0.05 in study 2). Survival analyses also revealed significant group differences in efficacy in both studies. Nicotine patches also suppressed a variety of withdrawal symptoms, including craving in the first weeks after patients quit smoking.
                Transdermal nicotine effectively augments smoking cessation rates with two different types of counseling treatment. Overall, the nicotine patch approximately doubles the sustained rate of smoking cessation. Additionally, the nicotine patch provides relief from some tobacco withdrawal symptoms. In a placebo-controlled, double-blind, 2-year prospective study, 182 smokers were given either nicotine polacrilex gum containing 4 mg of nicotine (n = 92) or a placebo (n = 90). The number of participants abstinent at 2-year follow-up was 41 (44.6%) of 92 in the nicotine group vs 28 (31.1%) of 90 in the placebo group. Abstinence rates for daily nicotine gum users (n = 64) at 12 months and again at 24 months remained 48.4%, as compared with 26.1% and 31.9% for the daily placebo gum users (n = 69). Of participants with a high nicotine-dependence score, those allotted to the nicotine group rather than to the placebo group were 13 times more likely to be abstaining at the 2-year follow-up. Use of nicotine polacrilex gum, therefore, can substantially aid in stopping smoking, particularly among highly dependent smokers. This study evaluated the effectiveness of nicotine chewing gum in smoking cessation, when incorporated into a behaviorally oriented self-help program. One hundred ninety-seven patients were randomly assigned to nicotine gum with a self-help manual, a self-help manual without gum, or a control condition, but received no further treatment from the prescribing physician. At six weeks, the nicotine gum group was superior to both the self-help and control conditions. By one year, many gum patients had relapsed, and the treatment effect was no longer significant. Patients who were able to quit initially were most likely to remain ex-smokers in the self-help condition. The clinical importance of these findings is discussed. A total of 424 smokers were randomized in a 2 x 2 factorial experiment. A pharmacologic factor contained 2 levels: transdermal nicotine path (TNP; 21 mg) and placebo. A self-help behavioral treatment factor contained 2 levels: video-enhanced self-help treatment manual and self-help treatment manual only. At 2 months, TNP produced a higher level of abstinence (36%) than placebo (20%), p < .001. No other comparison was significant. In secondary analyses, (at 2 months) and compliance with patch treatment regimen (at 2, 6, and 12 months) were associated with less relapse. Although nicotine replacement therapy has improved our ability to produce smoking cessation, the production of sustained, longer term abstinence remains an elusive goal. Nicotine replacement therapy has been shown to improve success rates in smoking cessation treatment. However, the available products cause adverse effects, which prevent some smokers from using them. A new method of delivering nicotine via inhaler supplies nicotine orally through inhalation from a plastic tube. This mode of delivering nicotine resembles smoking, as it includes handling and active inhalation.
                To assess the efficacy and safety of the nicotine inhaler as an aid in smoking cessation.
                A 1-year, randomized, double-blind, placebo-controlled study was conducted in a smoking cessation clinic. Two hundred forty-seven smokers who smoked at least 10 cigarettes per day and who had previously made a serious attempt to stop smoking using nicotine chewing gum were recruited through advertisements. Randomization to treatment or control conditions were made at the first group session, with 123 participants receiving nicotine inhalers and 124 receiving placebo inhalers. The inhalers were distributed at the second session and participants were allowed to use the inhalers for 6 months.
                Biochemically verified continuous abstinence from smoking after 2 and 6 weeks and at 3, 6, and 12 months.
                Significantly more participants who had used the nicotine inhalers were continuously abstinent compared with those who had used the placebo inhalers. The respective success rates after 12 months were 28% and 18% (P = .046). At 6 months, 20 participants (16%) in the nicotine group were still using the inhaler, compared with 4 (3%) in the control group (P < .001).
                The nicotine inhaler was an effective smoking cessation aid that produced a few mild and transient adverse effects. A transdermal nicotine patch, which delivers 0.7 mg/cm2 per 24 h and is available in sizes of 10, 20, and 30 cm2 was tested in subjects from 21 general medical practices in a 3-month, placebo-controlled randomised double-blind study. The nicotine group (n = 100) and the placebo group (n = 99) were similar at entry. Participants who smoked more than 20 cigarettes a day were treated with the 30 cm2 patch and the others with the 20 cm2 patch. When abstinence, defined as smoking 0-3 cigarettes per week and verified by CO measurement, was achieved, the next smallest patch was applied. After 1, 2, and 3 months of treatment 41, 36, and 36%, respectively, in the nicotine group were abstinent. The corresponding figures in the placebo group were 19, 20, and 23%. The differences were significant for all 3 months. Body weight did not increase in the nicotine group, but in the placebo group the mean increase was 4.4 kg. Craving and withdrawal symptoms decreased more with nicotine substitution for cigarettes. The patches were generally well tolerated, although 25% of subjects in the nicotine group and 13% in the placebo group had transient local erythema after application of the patch; 5 members of the nicotine group withdrew because of poor cutaneous tolerance. Cessation rates in smokers attending special clinics or their General Practitioners can be increased by transdermal nicotine (TNS). This study assesses the efficacy of TNS as an adjunct to advice and support in helping patients attending hospital with smoking-related diseases to stop smoking.
                In a double-blind, placebo-controlled, randomized manner, 234 inpatients and outpatients with smoking-related respiratory or cardiovascular disease, aged 18-75 years, who were willing to try to stop smoking, were advised by their hospital doctor to stop smoking. This was reinforced by repeated advice and encouragement from the Smoking Cessation Counsellor initially and at 2, 4, 8 and 12 weeks, supplemented by a 24 h patch in adjusted doses over that period. Those not smoking at 12 weeks were followed up at 26 and 52 weeks. Self-reported complete abstinence from 12 to 52 weeks was validated by expired air carbon monoxide measurement at 12, 26 and 52 weeks.
                Twenty-four (21%) of 115 TNS patients were verified as non-smokers at 12, 26 and 52 weeks and claimed continued abstinence, compared with 17 (14%) of 119 in the placebo (P) group (P = 0 center dot 15) -5% confidence limits for odds ratio of abstinence on TNS compared to P: 0 center dot 83, 3 center dot 37. Cessation was related to increasing age (P = 0 center dot 02) and lower Fagerstrom score (P = 0 center dot 05). Minor skin reactions were more frequent in the TNS group (47% TNS; 34% P), as was nausea (12% TNS; 3% P). Severe skin reactions were rare (5% TNS; 4% P).
                The suggestion that TNS produces an increase of 50% in relative terms (7% absolute increase) in smoking cessation over placebo in this population of hospital patients is sufficiently strong to warrant a further study large enough to answer whether or not this result was due to chance. nan Since nicotine gum was introduced in the 1980s, nicotine replacement therapy has become the most widely used pharmacological smoking cessation treatment. Some smokers prefer acute oral forms, but many smokers reject chewing gum. We tested the safety and efficacy of a new nicotine polacrilex lozenge for smoking cessation.
                Double-blind, placebo-controlled, randomized clinical trial with parallel arms testing 2- and 4-mg nicotine lozenges. Smokers (n = 1818) were assigned to a lozenge dose on the basis of nicotine dependence, assessed by time to the first cigarette of the day. Low-dependence smokers were randomized to receive the 2-mg nicotine (n = 459) or placebo (n = 458) lozenge; high-dependence smokers, the 4-mg nicotine (n = 450) or placebo (n = 451) lozenge. We assessed abstinence at 6, 12, 24, and 52 weeks and analyzed craving and withdrawal symptoms.
                Treatment with the nicotine lozenge resulted in significantly greater 28-day abstinence at 6 weeks, for the 2-mg (46.0% vs. 29.7%; odds ratio [OR], 2.10; 95% confidence interval [CI], 1.59-2.79; P<.001) and the 4-mg (48.7% vs. 20.8%; OR, 3.69; 95% CI, 2.74-4.96; P<.001) lozenges, compared with placebo. Significant treatment effects were maintained for a full year. Smokers who used more lozenges achieved significantly better treatment effects. Use of the active lozenge also resulted in reduced craving and withdrawal. Most adverse events were moderate and resembled those seen with nicotine gum.
                The nicotine lozenge is a safe and effective new treatment for smoking cessation in low- and high-dependence smokers. Smokers with a history of alcohol dependence may have more difficulty quitting, might relapse to alcohol use, and might especially benefit from nicotine replacement therapy for smoking cessation.
                One hundred fifteen smokers with a history of alcohol dependence (median of 5 years previously) were randomly assigned to either a 21-mg nicotine patch or placebo in a trial designed to be as similar as possible to a prior study that examined smokers with no history of alcoholism. Both studies were of heavy smokers with similar levels of nicotine dependence; thus, any differences in trials would be due to a history of alcohol problems per se.
                In the current trial, adjusted prolonged smoking abstinence in those with a history of alcohol dependence was higher in the active than the placebo group at end-of-treatment (28% vs. 11%; odds ratio, 3.2; p = 0.04) and at 6-month follow-up (24% vs. 6%; odds ratio, 4.9; p = 0.02). Among subjects not lost to follow-up, none reported drinking problems or increases in craving for alcohol. Smoking abstinence was not lower and the odds ratio for nicotine patch therapy was not greater in smokers with a history of alcohol dependence than in smokers with no such history.
                Heavy smokers with a history of alcoholism benefit from nicotine patch treatment. A history of alcohol problems after a period of stable sobriety does not appear to influence smoking outcomes or response to nicotine replacement. Although no smokers relapsed to alcohol use, a trial that follows up all subjects is needed to verify this. This study was conducted to determine the efficacy of the nicotine patch in smoking cessation when combined with self-help materials, three brief visits, and telephone counseling.
                One hundred fifty-nine healthy volunteers who smoked at least one pack of cigarettes per day and desired to quit smoking were enrolled in a double-blind trial with 6-week treatment and 6-month follow-up periods. After review of self-help materials, subjects were randomly assigned to regimens of nicotine or placebo patches. Subjects wore two patches per day for 4 weeks (25 mg of nicotine per 24 hours), then one patch per day for 2 weeks. Return visits were at the ends of weeks 4 and 6. Telephone counseling was given during weeks 1, 2, 3, and 5. Abstinence at 6 weeks was defined as zero cigarettes smoked for the previous 28 days, verified by exhaled carbon monoxide less than 8 ppm at 4 weeks and 6 weeks. Abstinence at 3 and 6 months was defined as self-report of zero cigarettes since the previous contact, verified by carbon monoxide value at 6 months.
                Abstinence rates at 6 weeks, 3 months, and 6 months were 29.5%, 21.8%, and 20.5% in the active group, and 8.8%, 3.8%, and 2.5% in the placebo group (P < or = .001 for each comparison), respectively. Skin irritation was the main side effect, causing 1.3% to drop out.
                The nicotine patch is efficacious in smoking cessation over a 6-month period, when combined with only self-help materials, three brief visits, and telephone counseling. This study examined the efficacy of transdermal nicotine in postmenopausal smokers, and whether a history of depression or hormone replacement therapy (HRT) moderated smoking cessation outcomes. Postmenopausal smokers (N=152) received intensive smoking cessation counseling and were randomly assigned to use either a 21-mg nicotine patch for 3 months, with a 1-month taper, or a placebo patch. The primary outcome was biochemically validated 7-day point prevalence smoking abstinence during treatment (i.e., 1, 2, 6, and 12 weeks after the quit date) and 1 year after study medication was discontinued. Subjects who received transdermal nicotine were significantly more likely than placebo-treated subjects to remain abstinent from smoking during treatment, but not at the 1-year follow-up. The majority of subjects (>50%) in both groups accurately identified their treatment assignment. History of depression was associated with a decreased likelihood to abstain from smoking throughout the study. HRT did not moderate smoking outcomes. These data indicate that transdermal nicotine may provide short-term benefits for smoking cessation in postmenopausal women. However, efforts are needed to improve long-term abstinence rates and smoking outcomes among women with a history of depression. Little direct evidence exists on the relative efficacies of different smoking cessation pharmacotherapies, yet such evidence is needed to make informed decisions about their clinical use.
                To assess the relative efficacies of 5 smoking cessation pharmacotherapy interventions using placebo-controlled, head-to-head comparisons.
                A randomized, double-blind, placebo-controlled clinical trial.
                Two urban research sites.
                One thousand five hundred four adults who smoked at least 10 cigarettes per day during the past 6 months and reported being motivated to quit smoking. Participants were excluded if they reported using any form of tobacco other than cigarettes; current use of bupropion; having a current psychosis or schizophrenia diagnosis; or having medical contraindications for any of the study medications.
                Participants were randomized to 1 of 6 treatment conditions: nicotine lozenge, nicotine patch, sustained-release bupropion, nicotine patch plus nicotine lozenge, bupropion plus nicotine lozenge, or placebo. In addition, all participants received 6 individual counseling sessions.
                Biochemically confirmed 7-day point-prevalence abstinence assessed at 1 week after the quit date (postquit), end of treatment (8 weeks postquit), and 6 months postquit. Other outcomes were initial cessation, number of days to lapse, number of days to relapse, and latency to relapse after the first lapse.
                All pharmacotherapies differed from placebo when examined without protection for multiple comparisons (odds ratios, 1.63-2.34). With such protection, only the nicotine patch plus nicotine lozenge (odds ratio, 2.34, P < .001) produced significantly higher abstinence rates at 6-month postquit than did placebo.
                While the nicotine lozenge, bupropion, and bupropion plus lozenge produced effects that were comparable with those reported in previous research, the nicotine patch plus lozenge produced the greatest benefit relative to placebo for smoking cessation. To estimate the safety and efficacy of treatment with 2-mg nicotine gum for smoking cessation during pregnancy.
                Pregnant women who smoked daily received individualized behavioral counseling and random assignment to a 6-week treatment with 2-mg nicotine gum or placebo followed by a 6-week taper period. Women who did not quit smoking were instructed to reduce the number of cigarettes smoked by substituting with gum. Measures of tobacco exposure were obtained throughout the study.
                Participants in the nicotine (n = 100) and placebo (n = 94) groups were comparable in age, race/ethnicity, and smoking history. Biochemically validated smoking-cessation rates were not significantly higher with nicotine gum compared with placebo (after 6 weeks of treatment: 13% compared with 9.6%, P=.45; at 32-34 weeks of gestation: 18% compared with 14.9%, P=.56). Using a completer analysis, nicotine gum significantly reduced the number of cigarettes smoked per day (nicotine gum: -5.7 [standard deviation (SD)=6.0]; placebo: -3.5 [SD=5.7], P=.035), and cotinine concentration (nicotine gum: -249 ng/mL [SD=397]; placebo: -112 ng/mL [SD=333]; P=.04). Birth weights were significantly greater with nicotine gum compared with placebo (3,287 g [SD=566] and 2,950 g [SD=653], respectively, P<.001). Gestational age was also greater with nicotine-replacement therapy than with placebo (38.9 weeks [SD=1.7] and 38.0 weeks [SD=3.3], respectively; P=.014).
                Although nicotine gum did not increase quit rates, use of nicotine gum increased birth weight and gestational age, two key parameters in predicting neonatal wellbeing. To determine whether 2-week pre-treatment with transdermal nicotine influences withdrawal symptoms or success rate of subsequent smoking cessation using nicotine patches.
                Randomized controlled trial.
                Smoking cessation clinic.
                Healthy smokers (n = 200, 45% female) were allocated randomly to either active nicotine-patch (AP, 15 mg daily, n = 100) or placebo-patch (PP, n = 100) pre-treatment. Baseline characteristics were well balanced except for daily cigarette consumption: mean (+/- SD) 23.1 (8) and 26.4 (11) for AP and PP groups, respectively (P = 0.021).
                At the screening visit (-2 weeks) subjects were counselled and started pre-treatment with daily patches (AP or PP). From the quit date (week 0) onwards all subjects received active nicotine patches for 12 weeks (15 mg daily for 8 weeks, 10 and 5 mg daily for 2 weeks each) and counselling.
                Follow-up visits included measurement of exhaled carbon monoxide at the quit date, 2, 6, 10 and 26 weeks. Subjects documented daily cigarette consumption and severity of withdrawal symptoms (Wisconsin scale) from -2 weeks to week 2. Outcome measures were withdrawal symptoms composite score and abstinence rates.
                There was no significant difference in withdrawal symptoms, but more subjects in the AP group were smoke-free during the 6-month study period. Overall sustained abstinence was documented in 17% of subjects at 6 months; 22% and 12% for AP and PP, respectively (P = 0.03). Retrospective subgroup analysis showed for subjects smoking >16 cigarettes/day sustained cessation rates were 22% and 9% for AP and PP, respectively (P = 0.01). No difference in adverse event rates was observed.
                Nicotine patch pre-treatment before cessation did not reduce early withdrawal symptoms but increased sustained abstinence rates at 6 months. The nicotine pre-treatment was equally effective in light and heavy smokers. Smoking is considered as an addiction to nicotine for most subjects consuming 10 cigarettes or more per day. Hence, nicotine replacement therapy by way of gum, patch, or spray has been advocated. The rationale of this study is to evaluate the possible beneficial effects of adding nicotine gum to the routine of subjects using the nicotine patch. The effect of the nicotine patch against the placebo, both groups receiving placebo nicotine gum, has also been assessed.
                Healthy subjects (374) were randomized at their work-setting in a 1-year double-blind placebo-controlled trial: 149 subjects to active nicotine patch + active gum (group 1), 150 to active nicotine patch + placebo gum (group 2), and 75 to placebo patch + gum (group 3). Treatment duration was 12 weeks with a 16-hr transdermal patch of 15 mg, followed by a 6 + 6-weeks weaning period on respectively 10 and 5 mg patches. Gum use was not restricted during the first 6 months, with recommendations to use at least four pieces a day. A strict definition of smoking abstinence was used in this study, which did not allow smoking any cigarette after Week 1. Nonsmoking status at each visit, as reported by the subjects, was verified by CO below 10 ppm in expired air.
                Abstinence rates in group 1 against group 2 were 34.2 and 22.7% (P = 0.027) at 12 weeks, 27.5 and 15.3% (P = 0.010) at 24 weeks, and 18.1 and 12.7% (P = 0.191) at 52 weeks. In group 3, abstinence rates were 17.3, 14.7, and 13.3% respectively at 12, 24, and 52 weeks. Using logistic regression with adjustment for six baseline covariates, odds ratios for abstinence (with 95% CI) were computed. For group 1/group 2, OR at 12, 24, and 52 weeks were 1.72 (1.03-2.94) (P = 0.039), 2.04 (1.14-3.57) (P = 0.018), and 1.47 (0.76-2.76) (P = 0.125). No significant differences in OR were observed when comparing groups 2 and 3. Time to relapse is significantly longer in group 1 as compared to that of group 2 (P = 0.041), whereas no significant differences between groups 2 and 3 were observed. No significant differences between the three groups in systemic and local adverse drug events were observed.
                Adding active gum use to active patch use in subjects smoking 10 cigarettes or more a day increased abstinence rates, which are statistically significant up to 24 weeks. The Collaborative European Anti-Smoking Evaluation (CEASE) was a European multicentre, randomized, double-blind placebo controlled smoking cessation study. The objectives were to determine whether higher dosage and longer duration of nicotine patch therapy would increase the success rate. Thirty-six chest clinics enrolled a total of 3,575 smokers. Subjects were allocated to one of five treatment arms: placebo and either standard or higher dose nicotine patches (15 mg and 25 mg daily) each given for 8 or 22 weeks with adjunctive moderately intensive support. The 12 month sustained success rates were: 25 mg patch for 22 weeks (L-25), 15.4%; 25 mg patch for 8 weeks (S-25), 15.9%; 15 mg patch for 22 weeks (L-15), 13.7%; 15 mg patch for 8 weeks (S-15), 11.7%; and placebo (P-0) 9.9% (placebo versus 15 mg, p<0.05; 25 mg versus 15 mg, p<0.03; 25 mg versus placebo, p<0.001, Chi-squared test). There was no significant difference in success rate between the two active treatment durations. Of the first week abstainers (n=1,698), 25.1% achieved success at 12 months as opposed to first week smokers, 2.7% of 1,877 subjects (p< 0.001). In summary, a higher than standard dose of nicotine patch was associated with an increase in the long-term success in smoking cessation but continuation of treatment beyond 8-12 weeks did not increase the success rates. Evaluation of the clinical efficacy and safety of a nicotine 2-mg sublingual tablet in smoking cessation.
                A randomized, double-blind, placebo-controlled study of smokers using the 2-mg tablet for 3-6 months with follow-up to 12 months. Dosing was established according to baseline nicotine dependence, scored on the Fagerström Tolerance Questionnaire (FTQ): FTQ > or = 7, two tablets/hour (maximum 40/day); FTQ < 7, one tablet/hour (maximum 20/day).
                Smoking cessation programme in a department of oral and maxillofacial surgery.
                A total of 247 adult smokers, smoking > or = 10 cigarettes/day for > or = 3 years, of whom 123 received active and 124 placebo treatment. The study was powered to detect difference at 6 months.
                Efficacy and safety were evaluated at 6 weeks and 3, 6 and 12 months. Self-reported abstinence was verified by exhaled CO < 10 p.p.m.
                Success rates for complete abstinence (no slips after 2 weeks) for active vs. placebo were 50% vs. 29% at 6 weeks, 42% vs. 23% at 3 months, 33% vs. 18% at 6 months and 23% vs. 15% at 12 months (p < 0.001, 0.001, 0.005 and p = 0.14), respectively. Craving during the first 8 days was significantly reduced among highly dependent smokers on active treatment compared to placebo. Baseline mucosal lesions among abstinent subjects were reduced during the treatment period and at the non-treatment follow-up. Adverse events were mild and tolerable, the most common being irritation and soreness in the mouth and throat.
                The nicotine sublingual tablet increased the smoking cessation rate compared to placebo, reduced craving in highly dependent smokers and was well tolerated. Two hundred and ten subjects entered a trial to test the use of a chewing gum containing nicotine as an aid to stopping smoking. They were divided into three groups: nicotine chewing gum, placebo chewing gum, and control. The trial was double blind between the two chewing gum groups. After 1 month the percentage of confirmed non-smokers in the nicotine gum group was 34%, in placebo chewing gum group 37% and the control group 24%. By 6 months most of the non-smokers had relapsed, but the nicotine gum group (23%) was more successful than the placebo (5% or the control group (14%). nan Smoking cessation has been shown to be effective in randomized controlled trials. It is unclear though, whether interventions also work in routine primary care.
                In 167 primary care settings we conducted a randomized four-armed smoking cessation trial to examine the efficacy of a minimal intervention (MI; n = 81), cognitive-behavioral therapy (CBT; n = 175), bupropion (BUP; n = 108) and nicotine replacements (NRT; n = 103). Overall, 467 current smokers were enrolled. Abstinence rates at the end of treatment (12 weeks) were 32.8% for MI patients, 34.8% for CBT, 35.3% for NRT, and 46.5% for BUP patients (ITT, intention to treat) (no differential effects). Retention rates were highest in the BUP group (59.3%) and lowest in the NRT group (50.5%). Completer findings were: MI, 56.4%; CBT, 64%; BUP, 79.3%; NRT, 69.2% (LOCF, lost to follow-up). No serious adverse events occurred during or after the medication phase. At 12-month follow-up continuous abstinence rates were: BUP, 29.0%; CBT, 20.9%; NRT, 29.6%; MI, 29.6%.
                Our findings suggest that established smoking cessation treatments are effective when applied by non-specialist primary care physicians. Our data supports a structured, multimodal treatment structure as core ingredient of successful smoking cessation in primary care.
                Copyright © 2011 John Wiley & Sons, Ltd. Transdermal nicotine therapy is widely used to aid smoking cessation, but there is uncertainty about its safety in patients with cardiac disease.
                In a randomized, double-blind, placebo-controlled trial at 10 Veterans Affairs medical centers, we randomly assigned 584 outpatients (of whom 576 were men) with at least one diagnosis of cardiovascular disease to a 10-week course of transdermal nicotine or placebo as an aid to smoking cessation. The subjects were monitored for a total of 14 weeks for the primary end points of the study (death, myocardial infarction, cardiac arrest, and admission to the hospital due to increased severity of angina, arrhythmia, or congestive heart failure); the secondary end points (admission to the hospital for other reasons and outpatient visits necessitated by increased severity of heart disease); any side effects of therapy; and abstinence from smoking.
                There were 48 primary and 78 secondary end points noted in a total of 95 subjects. At least one of the primary end points was reached by 5.4 percent of the subjects in the nicotine group and 7.9 percent of the subjects in the placebo group (difference, 2.5 percent; 95 percent confidence interval, -1.6 to 6.5 percent; P=0.23). In the nicotine group, 11.9 percent of the subjects had at least one of the secondary end points, as compared with 9.7 percent in the placebo group (difference, 2.2 percent; 95 percent confidence interval, -2.2 to 7.4 percent; P= 0.37). After 14 weeks the rate of abstinence from smoking was 21 percent in the nicotine group, as compared with 9 percent in the placebo group (P=0.001), but after 24 weeks the abstinence rates were not significantly different (14 percent vs. 11 percent, P= 0.67).
                Transdermal nicotine does not cause a significant increase in cardiovascular events in high-risk outpatients with cardiac disease. However, the efficacy of transdermal nicotine as an aid to smoking cessation in such patients is limited and may not be sustained over time. Approximately 50% of African American smokers are light smokers (smoke < or = 10 cigarettes a day). The prevalence of light smoking in the United States is increasing, yet there has not been a single smoking cessation clinical trial targeting light smokers. The purpose of this 2 x 2 factorial, randomized clinical trial was to evaluate the efficacy of nicotine gum (2 mg versus placebo) and counseling (motivational interviewing versus health education) for African American light smokers.
                Participants were assigned randomly to one of four study arms: 2 mg nicotine gum plus health education (HE); 2 mg nicotine gum plus motivational interviewing (MI); placebo gum plus HE; and placebo gum plus MI.
                A total of 755 African American light smokers (66% female, mean age = 45) were enrolled at a community health center over a 16-month period.
                Participants received an 8-week supply of nicotine gum and six counseling sessions during the course of the 26-week study. Biochemical measures included expired carbon monoxide (CO) and serum and salivary cotinine.
                Seven-day quit rates for nicotine gum were no better than for the placebo group (14.2% versus 11.1%, P = 0.232) at 6 months. However, a counseling effect emerged, with HE performing significantly better than MI (16.7% versus 8.5%, P < 0.001). These results were consistent across outcome time-points (weeks 1, 8, and 26).
                Results highlight the potential positive impact of directive information and advice-oriented counseling on smoking cessation. Studies are needed to assess other interventions that may further improve quit rates among African American light smokers who are motivated to quit. To determine the safety and efficacy of the nicotine patch and gum for adolescents who want to quit smoking.
                Double-blind, double-dummy, randomized, 3-arm trial with a nicotine patch (21 mg), nicotine gum (2 and 4 mg), or a placebo patch and gum; all participants received cognitive-behavioral group therapy.
                Inner-city, outpatient clinic on the East Coast. Subjects. Thirteen- to 17-year-old adolescents who smoked > or =10 cigarettes per day (CPD), scored > or =5 on the Fagerstrom Test of Nicotine Dependence, and were motivated to quit smoking. Intervention. Twelve weeks of nicotine patch or gum therapy with cognitive-behavioral therapy, with a follow-up visit at 6 months (3 months after the end of treatment).
                Safety assessed on the basis of adverse event reports for all 3 groups, prolonged abstinence, assessed through self-report and verified with exhaled carbon monoxide (CO) levels of < or =6 ppm, in intent-to-treat analyses, and smoking reduction (CPD and thiocyanate concentrations) among trial completers.
                A total of 120 participants were randomized (72% white, 70% female; age: 15.2 +/- 1.33 years; smoking: 18.8 +/- 8.56 CPD; Fagerstrom Test of Nicotine Dependence score: 7.04 +/- 1.29) from 1999 to 2003. Participants started smoking at 11.2 +/- 1.98 years of age and had been smoking daily for 2.66 +/- 1.56 years; 75% had at least 1 current psychiatric diagnosis. Mean compliance across groups was higher for the patch (mean: 78.4-82.8%) than for the gum (mean: 38.5-50.7%). Both the patch and gum were well tolerated, and adverse events were similar to those reported in adult trials. Changes in mean saliva cotinine concentrations throughout treatment were not statistically significant. Intent-to-treat analyses of all randomized participants showed CO-confirmed prolonged abstinence rates of 18% for the active-patch group, 6.5% for the active-gum group, and 2.5% for the placebo group; the difference between the active-patch and placebo arms was statistically significant. There was no significant effect of patch versus gum or gum versus placebo on cessation outcomes. Abstinence rates at the 3-month follow-up assessment were sustained but were not significantly associated with treatment group. Mean smoking rates, but not CO or thiocyanate concentrations, decreased significantly in all 3 arms but not as a function of treatment group.
                Nicotine patch therapy combined with cognitive-behavioral intervention was effective, compared with placebo, for treatment of tobacco dependence among adolescent smokers. Decreases in the numbers of cigarettes smoked appeared to be offset by compensatory smoking. Additional study of nicotine gum, with enhanced instructional support, is needed to assess its efficacy among adolescent smokers. nan The efficacy of physician anti-smoking intervention with 289 patients in a family practice setting was assessed. The design included two treatment conditions, physician advice and physician advice plus the offer of nicotine chewing gum (NCG) prescription. A no-advice group permitted assessment of the effects of repeated testing. The NCG group had higher rates of abstinence at all follow-up points, but the difference approached statistical significance at 3 months only (p less than .10). Comparison of those who actually used NCG to all other groups revealed significantly more users were abstinent at 1- and 3-month follow-up. A similar pattern occurred for proportion attempting cessation and smoking reduction. A dose-response relationship of gum use to outcome was identified. Long-term users (greater than 20 days) had 86% abstinence at 3 months versus 18% for short-term users. Thus, NCG does appear to have a role in family practice for promoting short-term cessation. Nicotine-replacement therapy is effective for smoking cessation outside pregnancy and its use is widely recommended during pregnancy. We investigated the efficacy and safety of nicotine patches during pregnancy.
                We recruited participants from seven hospitals in England who were 16 to 50 years of age with pregnancies of 12 to 24 weeks' gestation and who smoked five or more cigarettes per day. Participants received behavioral cessation support and were randomly assigned to 8 weeks of treatment with active nicotine patches (15 mg per 16 hours) or matched placebo patches. The primary outcome was abstinence from the date of smoking cessation until delivery, as validated by measurement of exhaled carbon monoxide or salivary cotinine. Safety was assessed by monitoring for adverse pregnancy and birth outcomes.
                Of 1050 participants, 521 were randomly assigned to nicotine-replacement therapy and 529 to placebo. There was no significant difference in the rate of abstinence from the quit date until delivery between the nicotine-replacement and placebo groups (9.4% and 7.6%, respectively; unadjusted odds ratio with nicotine-replacement therapy, 1.26; 95% confidence interval, 0.82 to 1.96), although the rate was higher at 1 month in the nicotine-replacement group than in the placebo group (21.3% vs. 11.7%). Compliance was low; only 7.2% of women assigned to nicotine-replacement therapy and 2.8% assigned to placebo used patches for more than 1 month. Rates of adverse pregnancy and birth outcomes were similar in the two groups.
                Adding a nicotine patch (15 mg per 16 hours) to behavioral cessation support for women who smoked during pregnancy did not significantly increase the rate of abstinence from smoking until delivery or the risk of adverse pregnancy or birth outcomes. However, low compliance rates substantially limited the assessment of safety. (Funded by the National Institute for Health Research Health Technology Assessment Programme; Current Controlled Trials number, ISRCTN07249128.). To assess the efficacy and safety of a repeat course of treatment with transdermal nicotine for cessation of smoking in a brief intervention setting.
                Randomised, double blind, placebo controlled trial with follow up for 26 weeks.
                629 smokers who had unsuccessfully attempted to stop smoking by using active transdermal nicotine and brief behavioural counselling. Smokers were motivated to quit smoking for a second time and smoked > or = 15 cigarettes a day.
                Twelve weeks' treatment with active transdermal nicotine patches or placebo and brief counselling at monthly visits.
                Sustained smoking cessation for the 28 days before the visit at week 12 verified by expired carbon monoxide concentrations.
                At 12 weeks 21/315 (6.7%) subjects allocated to active treatment had stopped smoking compared with 6/314 (1.9%) allocated to placebo (absolute difference 4.7%; 95% confidence interval 1.6% to 7.9%; P = 0.003). At 26 weeks the rates were 20/315 (6.4%) and 8/314 (2.6%) (3.8%; 0.6% to 7.0%; P = 0.021). Difficulty in sleeping was reported by 43/179 (24.0%) on active treatment and 19/143 (13.3%) on placebo (P = 0.015). Severe reactions at the site of application were rare (6/322; 1.9%).
                Repeated treatment with transdermal nicotine together with brief counselling can improve the low success rates of smoking cessation in recently relapsed, moderate to heavy smokers. Questions remain about whether more intensive interventions or higher doses of nicotine could be more effective. The likelihood of severe reactions at the site of application with repeated treatment is low. Nicotine gum has been shown to be effective in improving abstinence rates, and in reducing post-cessation withdrawal distress and weight gain. However, the dose effects of nicotine gum on these outcomes is not known. In the present study, we varied the amount of 2 mg nicotine gum prescribed to motivated quitters to explore the hypotheses (a) that motivated quitters would use more pieces of gum when coached and counseled to do so and (b) that there would be a dose-related effect of gum use on abstinence, withdrawal symptoms, and weight gain. One hundred seventy-seven volunteers were assigned to chew either 0, 7, 15, or 30, pieces per day of 2 mg nicotine gum. Biological verification of gum use and smoking abstinence were assessed in community volunteers who attended an intensive behavioral counseling program for smoking cessation while using nicotine gum for 3 months. In the survival analysis at 12 weeks, gum-group assignment was not related to successful abstinence. In the subset of 42 abstinent subjects, there was a strong positive relationship between pieces per day of nicotine gum used and saliva cotinine. However, there was substantial variability in groups of subjects reporting similar amounts of gum use. Withdrawal symptom reporting was not related to either gum use or cotinine levels. Weight gain was significantly related in a dose-dependent manner to salivary cotinine levels, but not to gum group assignment, with high and low cotinine subjects gaining on average, 4.0 and 6.6 pounds, respectively. Discussion of the use of high levels of nicotine gum is addressed. Consistent with earlier work, the study provided further support for the relationship between nicotine replacement level and post-cessation weight gain. The purpose of this study was to examine the effectiveness of different practice-based approaches to assist patients of primary care physicians to quit smoking and sustain cessation. Forty-four nonsmoking general practitioners volunteered for the study. After a period of training, they randomized 923 smoking clients, unselected for motivation toward quitting, to four different intervention groups: (i) minimal intervention, consisting of one single counselling session and a brief handout on quitting techniques; (ii) repeated counselling including reinforcing sessions at Months 1, 3, 6, and 9; (iii) repeated counselling and use of nicotine gum; and (iv) repeated counselling and spirometry. Biochemically validated smoking status was assessed at six and 12 months after recruitment. The proportion of verified quitters at 12 months was 4.8 percent among subjects randomized to the minimal intervention group, compared to 5.5 percent, 7.5 percent, and 6.5 percent among those randomized to the three repeated-counselling groups. In no treatment group was the outcome significantly different from that for one-time counselling at the (P less than 0.05) level. Lack of power, contamination, and low attendance at reinforcing sessions should be taken into account in interpreting the results. nan nan nan nan The use of nicotine chewing gum combined with psychological support improves the success rate in quitting smoking. We studied the safety and efficacy of a transdermal nicotine patch in smoking cessation.
                We conducted a double-blind randomized study comparing the effects of a 16-hour nicotine patch (15 +/- 3.5 mg of nicotine in 16 hours) with those of a placebo patch. Of the 289 smokers (207 women and 82 men) enrolled in the study, 145 were treated with nicotine patches and 144 with placebo patches for 16 weeks.
                Rates of sustained abstinence were significantly better with active treatment than with placebo: 53, 41, 24, and 17 percent of those in the nicotine-patch group were abstinent after 6, 12, 26, and 52 weeks, respectively, as compared with 17, 10, 5, and 4 percent of those in the placebo-patch group (P less than 0.0001). Only two subjects with the nicotine patch and one with the placebo patch had to withdraw from the study because of side effects.
                The nicotine skin patch proved to be safe and effective, as demonstrated by a higher rate of abstinence than with placebo. However, the absolute rate of abstinence after one year was only 17 percent, which is lower than the rate in studies that have combined the use of nicotine chewing gum with behavioral therapy. To determine whether use of an oral nicotine inhaler can result in long term reduction in smoking and whether concomitant use of nicotine replacement and smoking is safe.
                Double blind, randomised, placebo controlled trial. Four month trial with a two year follow up.
                Two university hospital pulmonary clinics in Switzerland.
                400 healthy volunteers, recruited through newspaper advertisements, willing to reduce their smoking but unable or unwilling to stop smoking immediately.
                Active or placebo inhaler as needed for up to 18 months, with participants encouraged to limit their smoking as much as possible.
                Number of cigarettes smoked per day from week six to end point. Decrease verified by a measurement of exhaled carbon monoxide at each time point compared with measurement at baseline.
                At four months sustained reduction of smoking was achieved in 52 (26%) participants in the active group and 18 (9%) in the placebo group (P<0.001; Fisher's test). Corresponding figures after two years were 19 (9.5%) and 6 (3.0%) (P=0.012).
                Nicotine inhalers effectively and safely achieved sustained reduction in smoking over 24 months. Reduction with or without nicotine substitution may be a feasible first step towards smoking cessation in people not able or not willing to stop abruptly. Smokers aged 18 to 65 years (N = 1,044) who were able to quit for 24 hr were randomized using a 2 x 2 factorial design to compare nicotine gum to no gum use and self-help materials to no use of materials. All participants were offered a $100 incentive to quit and stay quit for 6 months. Six-month abstinence was 27% in the gum groups, compared with 19% in the no-gum group (p = .002). Compared with the no-gum group, relapse occurred at a significantly lower rate in the gum group for the entire 12 months of follow-up (odds of relapse in the gum group was 0.72, 95% confidence interval, 0.62 to 0.83). There was no significant main effect for the self-help materials, no interaction between gum and materials, and no evidence that the effectiveness of gum differed between the sexes or between heavy and light smokers. Nicotine gum is an effective adjunct to minimal-contact smoking cessation materials plus monetary incentive in a population-based sample of smokers. The Freedom from Smoking clinic programs offered by the American Lung Association are in widespread use. These programs were developed in the 1970s prior to the availability of nicotine gum in the United States. It was hypothesized that the addition of nicotine gum to these clinics (thereby including both behavioral and pharmacologic intervention) would boost abstinence outcome significantly. Two-hundred and seventy-three persons were randomly assigned to Freedom from Smoking clinics with or without prescription of nicotine gum. Abstinence outcomes at one week favored the nicotine gum conditions (86.3% of nicotine gum subjects were abstinent as opposed to 70.9% of comparison subjects, chi 2(1) = 9.79, p = .002). Effects for gum were no longer significant at later follow-ups, however, Overall duration and level of nicotine gum use were considerably less than optimal. In the absence of a placebo gum control group, expectancy cannot be eliminated as a possible explanation of the short-term results. To evaluate the effectiveness of the Nicotrol nicotine inhaler as an aid to smoking cessation in over-the-counter (OTC) versus health-care-provider (HCP) conditions.
                Five hundred twenty healthy smokers were randomized to the treatment conditions and followed for a year.
                At most follow-up visits, abstinence rates for the HCP group were 2 to 3 times those observed in the OTC group. Abstinence at 1 year was.77% in the OTC condition versus 3.08% in the HCP condition [P<.01]. Inhaler use was low.
                OTC nicotine inhaler appears to be ineffective, though quit rates are improved with HCP assistance. Randomized efficacy clinical trials conducted in research settings may not accurately reflect the benefits of tobacco dependence treatments when used in real-world clinical settings. Effectiveness trials (eg, in primary care settings) are needed to estimate the benefits of cessation treatments in real-world use.
                A total of 1346 primary care patients attending routine appointments were recruited by medical assistants in 12 primary care clinics. Patients were randomly assigned to 5 active pharmacotherapies: 3 monotherapies (nicotine patch, nicotine lozenge, and bupropion hydrochloride sustained release [SR]) and 2 combination therapies (patch + lozenge and bupropion SR + lozenge). Patients were referred to a telephone quit line for cessation counseling. Primary outcomes included 7-day point prevalence abstinence at 1 week, 8 weeks, and 6 months after quitting and number of days to relapse.
                Among 7128 eligible smokers (> or =10 cigarettes per day) attending routine primary care appointments, 1346 (18.9%) were enrolled in the study. Six-month abstinence rates for the 5 active pharmacotherapies were the following: bupropion SR, 16.8%; lozenge, 19.9%; patch, 17.7%; patch + lozenge, 26.9%; and bupropion SR + lozenge, 29.9%. Bupropion SR + lozenge was superior to all of the monotherapies (odds ratio, 0.46-0.56); patch + lozenge was superior to patch and bupropion monotherapies (odds ratio, 0.56 and 0.54, respectively).
                One in 5 smokers attending a routine primary care appointment was willing to make a serious quit attempt that included evidence-based counseling and medication. In this comparative effectiveness study of 5 tobacco dependence treatments, combination pharmacotherapy significantly increased abstinence compared with monotherapies. Provision of free cessation medications plus quit line counseling arranged in the primary care setting holds promise for assisting large numbers of smokers to quit. Trial Registration clinicaltrials.gov Identifier: NCT00296647. nan The effectiveness of nicotine gum in combination with a behavior modification program was studied. The nicotine dependence of participating smokers (N = 322) was assessed. One hundred sixty-eight smokers were labeled as high nicotine dependent and 154 as moderate to low dependent. In a randomized double-blind procedure, the high-dependent smokers were given gum containing 4 mg of nicotine (87) or 2 mg of nicotine (81) and the smokers with medium or low dependence were given gum containing 2 mg (76) or a placebo gum (78). The smokers were also randomized to familiarizing themselves with the medication a week before quit day (112) or to regular use, that is starting gum use on the quit day (122). In the high-dependent group, sustained and chemically verified nonsmoking rates at 6 weeks, 1 year, and 2 years were, respectively, 60%, 39%, and 34% in the subjects given the 4-mg dose compared with 41%, 16%, and 16% for those using the 2-mg dose. In the group with medium or low dependence, the success rates at the same time periods were 70%, 49%, and 39% for the subjects given the 2-mg dose and 38%, 22%, and 17% for those given placebo gum. The differences in success rates were significant at least at the p < 0.02% level for all comparisons. Familiarizing with the gum as compared with regular use gave fewer reports of side effects, 15% vs 34%, p < 0.001. A trend toward better success rates at 6 weeks, although not statistically significant, was observed for the familiarization group, 61% vs 52%. The study shows that high nicotine-dependent smokers need higher doses of nicotine replacement, in this case the 4-mg dose rather than the 2-mg dose, whereas 2 mg is superior to placebo among less dependent smokers. These results compare favorably with those reported from the more recent nicotine patch therapy. Smokers (N = 126) were randomly assigned to 6-session smoking cessation treatments consisting of 1 of 2 counseling strategies (skills training or support) and 1 of 2 nicotine exposure strategies (nicotine gum or rapid smoking). Counseling and nicotine strategies were completely crossed; all four combinations resulted in equivalent 1-year abstinence rates. Skills training produced higher initial cessation and more coping responses posttreatment than did support. Rapid smoking, but not nicotine gum, produced tachycardia to the taste of cigarettes posttreatment, consistent with cigarette aversion. The treatments were differentially effective among subpopulations of smokers: Subjects high in pretreatment negative affect responded best to support counseling; those low in pretreatment negative affect responded best to skills training. Self-reports of pretreatment craving predicted response to the nicotine exposure treatments. The study examined the impact of counseling intensity (high vs. low) combined with either bupropion or the nicotine patch. Two hundred sixty participants smoking 6 to 15 cigarettes per day (cpd) were enrolled in a year-long study to examine the effects of treatment. Four groups of smokers under medication-blinded conditions were compared for treatment completion and abstinence at three follow-up points from the initiation of treatment (Weeks 12, 26, and 52). Both counseling groups had similar treatment completion rates (i.e., defined by a combination of counseling attendance and medication adherence levels). There was a main treatment effect for abstinence favoring the high counseling condition in early follow-up (Week 12) and for continuous abstinence. Participants with a history of heavier smoking (> or =20 cpd) and African American smokers were least likely to be smoke free at the end of the study. The study has implications for identifying the treatment needs of lighter smokers. The effect of 2-mg nicotine chewing gum as an adjunct to group therapy for smoking cessation was studied in a placebo-controlled, double-blind, randomized trial. After one year, 29% of the 106 subjects treated with nicotine chewing gum had remained abstinent throughout the year compared with 16% of the 99 subjects treated with placebo. The results were confirmed by measurement of levels of expired CO. More subjects in the nicotine group (70/94 v 45/93) reported that the gum reduced the craving for smoking. The adverse effects were few and not serious. In the nicotine group, 3% were still using the nicotine gum after two years. No subjects in the placebo group used the chewing gum beyond six months. Nicotine chewing gum is effective in improving the success rates in smoking cessation based on group therapy. We studied the effectiveness of chewing gum containing nicotine, in combination with group counseling, for subjects who were attempting to stop smoking. We used the Horn-Russell scale, based on a smoking questionnaire, to measure dependence on cigarettes; 173 smokers were grouped as highly dependent on nicotine or as having medium to low degrees of dependence. In a randomized double-blind study, the 60 highly dependent smokers were given gum containing 4 mg of nicotine (n = 27) or 2 mg of nicotine (n = 33), and the 113 smokers with medium or low dependence were given gum containing 2 mg of nicotine (n = 60) or a placebo gum (n = 53). All smokers took part in group counseling. In the highly dependent group, abstinence from cigarettes was chemically verified after six weeks, one year, and two years; 81.5 percent, 44.4 percent, and 33.3 percent of the subjects given gum containing 4 mg of nicotine were abstinent after those follow-up periods; the rates of abstinence were 54.5 percent, 12.1 percent, and 6.1 percent, respectively, for the subjects given gum containing 2 mg of nicotine. In the group with medium or low dependence, the rates of abstinence after the same periods were 73.3 percent, 38.3 percent, and 28.3 percent for the subjects given gum containing 2 mg of nicotine and 41.5 percent, 22.6 percent, and 9.4 percent for those given placebo gum. The differences in outcomes were significant at the 5 percent level for all comparisons, with the exception of the 2-mg nicotine gum versus the placebo gum at one year. This study indicates that the effectiveness of nicotine gum is not due to a placebo effect and that it is related to dose. The use of nicotine gum in appropriate doses should be helpful to persons who are attempting to stop smoking. Nicotine replacement therapy (NRT) is a well-established treatment to aid smoking cessation, and current products recommend using NRT only after quitting smoking. However, theoretical arguments and previous data support the hypothesis that precessation use of NRT might be useful in reducing dependence on inhaled nicotine and serve as a helpful prelude to smoking cessation. The present study explored the use of NRT for 2 weeks before a target quit-smoking date, during which subjects continued to smoke ad libitum. Three experimental conditions varied the nicotine delivery of the cigarettes smoked during these 2 weeks so that we could examine the effects of concurrent nicotine administration on compensatory smoking of low tar and nicotine cigarettes. Subjects smoked (a) their usual brands of cigarettes, (b) conventional low tar and nicotine cigarettes, or (c) denicotinized cigarettes. After the quit date, subjects received pharmacotherapy consisting of various doses of NRT (0, 21, or 42 mg/24-hr) in combination with the nicotinic antagonist mecamylamine (10 mg/day). Results showed that precessation nicotine patch treatment was associated with a significantly higher rate of continuous smoking abstinence at 4 weeks, regardless of cigarette condition. Ad libitum smoking before the target quit date was modulated by nicotine patch treatment, and compensatory increases in smoking low tar and nicotine cigarettes were prevented by concurrent use of nicotine patches. These results suggest that use of NRT before a target quit-smoking date deserves further evaluation as a possible smoking cessation treatment. Moreover, while nicotine patches were well tolerated when subjects smoked nicotine-containing cigarettes, the use of nicotine skin patches with reduced-nicotine cigarettes potentially offers the advantage of increased efficacy without introducing concern about toxic effects of excessive nicotine intake. Earlier research indicated that a 10-session mood management (MM) intervention was more effective than a 5-session standard intervention for smokers with a history of major depressive disorder (MDD). In a 2 x 2 factorial design, the present study compared MM intervention to a contact-equivalent health education intervention (HE) and 2 mg to 0 mg of nicotine gum for smokers with a history of MDD. Participants were 201 smokers, 22% with a history of MDD. Contrary to the earlier findings, the MM and HE interventions produced similar abstinence rates: 2 mg gum was no more effective than placebo. History-positive participants had a greater increase in mood disturbance after the quit attempt. Independent of depression diagnosis, increases in negative mood immediately after quitting predicted smoking. No treatment differences were found in trends over time for measures of mood, withdrawal symptoms, pleasant activities and events, self-efficacy, and optimism and pessimism. History-positive smokers may be best treated by interventions providing additional support and contact, independent of therapeutic content. The nicotinic antagonist mecamylamine was evaluated in a randomized smoking cessation trial. Four groups of participants (n = 20 per group) received nicotine plus mecamylamine, nicotine alone, mecamylamine alone, or no drug for 4 weeks before cessation. After the quit-smoking date, all subjects received nicotine plus mecamylamine treatment for 6 weeks. Nicotine skin patches (21 mg/24 hr) and mecamylamine capsules (2.5-5.0 mg twice per day) were used. Precessation mecamylamine significantly prolonged the duration of continuous smoking abstinence; abstinence rates at the end of treatment were 47.5% with mecamylamine and 27.5% without mecamylamine. Nicotine + mecamylamine reduced ad lib smoking, smoking satisfaction, and craving more than either drug alone. Moreover, the orthostatic decrease in blood pressure caused by mecamylamine was offset by nicotine. Mecamylamine before smoking cessation may be an effective adjunct to nicotine patch therapy. New ways of improving the efficacy of nicotine therapy need to be explored. We tested whether starting nicotine polacrilex gum treatment 4 weeks before the quit date improved smoking abstinence rates compared with starting treatment on the quit date.
                An open randomized trial of 314 daily smokers (mean, 23.7 cigarettes/d) enrolled through the Internet and by physicians in Switzerland from November 2005 to January 2007. In the precessation treatment group, participants received nicotine polacrilex gum (4 mg, unflavored) by mail for 4 weeks before and 8 weeks after their target quit date, and they were instructed to decrease their cigarette consumption by half before quitting. In the usual care group, participants received the same nicotine gum for 8 weeks after their quit date and were instructed to quit abruptly. Instructions were limited to a booklet sent by mail and access to a smoking cessation Web site. Results are expressed as self-reported abstinence rates at the end of treatment and as biochemically verified smoking abstinence (cotinine plus carbon monoxide) after 12 months.
                Eight weeks after the target quit date, self-reported 4-week abstinence rates were 41.6% in the precessation treatment group and 44.4% in the usual care group (P = .61). One year after the target quit date, biochemically verified 4-week smoking abstinence rates were 20.8% in the precessation treatment group and 19.4% in the usual care group (P = .76).
                Starting nicotine gum treatment 4 weeks before the target quit date was no more effective than starting treatment on the quit date. To evaluate concurrent administration of mecamylamine (nicotine antagonist) with nicotine skin patch treatment for smoking cessation.
                This was a randomized, double-blind, placebo-controlled trial. Forty-eight healthy smokers who smoked at least one pack per day were studied at an outpatient smoking cessation research clinic. The subjects ranged in age from 20 to 40 years. Intervention with the nicotine skin patch (6 to 8 weeks) plus oral mecamylamine (2.5 to 5 mg twice a day for 5 weeks) was compared to nicotine patch plus placebo. Mecamylamine treatment began 2 weeks before smoking cessation. The primary outcome was continuous abstinence through 7 weeks after cessation (1 week after treatment), confirmed by expired air carbon monoxide measurements. Secondary measures included point abstinence at 7 weeks, continuous abstinence at 6- and 12-month follow-up, and self-reported withdrawal symptoms.
                The continuous abstinence rate at 7 weeks was three times higher in the mecamylamine condition: 50% versus 16.7%, p = 0.015. Point abstinence at 7 weeks was 58% for mecamylamine versus 29% for placebo, p = 0.044. At follow-up, continuous abstinence remained higher for mecamylamine: 37.5% versus 12.5% at 6 months (p = 0.046) and 37.5% versus 4.2% at 12 months (p = 0.004). Mecamylamine also significantly reduced craving for cigarettes, negative affect, and appetite.
                Agonist-antagonist therapy, consisting of the nicotine patch with oral mecamylamine, may substantially improve current smoking cessation treatment. 1,218 smokers able to quit smoking for 48 hr were randomly assigned to one of 12 cells in a 4 x 3 fully crossed factorial experiment. A pharmacologic factor contained four levels: nicotine polacrilex (gum) delivered ad lib or on a fixed regimen, placebo gum, and no gum. A self-guided behavioral treatment factor contained three levels: self-selected relapse prevention modules, randomly administered modules, and no modules. Those receiving nicotine gum were more likely to be abstinent at the 2- and 6-month follow-ups. The fixed regimen accounted for most of the effect for gum. There was no effect for the relapse prevention module factor. Men and women showed a differential treatment response. Men who received nicotine gum were more likely to be abstinent at each follow-up (2, 6, and 12 months). No treatment was significantly better among women. We conclude that research on different gum chewing regimens is warranted and that further examination of possible gender differences in response to replacement therapy is needed. To test the effect of nicotine gum and placebo in smokers not motivated or not able to quit smoking with regard to smoking reduction and smoking cessation.
                This randomized study evaluated nicotine gum versus placebo for up to 1 year in 411 healthy smokers highly motivated to reduce cigarette use. Smoking reduction was defined as self-reported daily smoking less than 50% of baseline and any decrease (1 p.p.m. or more) in carbon monoxide.
                Pulmonary department, Copenhagen, Denmark.
                The overall success rate for sustained smoking reduction was significantly higher at all time-points for active versus placebo gum (6.3% versus 0.5% after 24 months). Nicotine gum achieved significantly higher point prevalence cessation rates than placebo at 12 and 24 months [11.2% versus 3.9% (odds ratio = 3.1; 95% CI, 1.4-7.2 and 9.3% versus 3.4% (odds ratio = 2.9; 95% CI, 1.2-7.1), respectively]. There was a linear relationship between decrease in number of daily cigarettes and decrease in plasma cotinine, exhaled carbon monoxide and plasma thiocyanate, with significantly greater reduction in the nicotine gum group after 4 and 12 months (maximum treatment duration) but not after 24 months. The decrease in toxin intake was smaller than the decline in daily cigarette consumption, suggesting that compensatory smoking occurred.
                Nicotine gum promoted cessation in this population of smokers unwilling to quit. Among reducers, the toxin intake correlated with reduced cigarette consumption although some compensatory smoking occurred. Previous studies have reported that smoking abstinence rates are increased when nicotine skin patch treatment is initiated prior to the target quit smoking date, as compared with conventional treatment beginning on the quit date. We hypothesized that smoking in the presence of continuous levels of nicotine would attenuate the reinforcing effects of cigarette smoking and lead to a decline in dependence on inhaled nicotine, thus facilitating cessation.
                This study involved four groups of smokers (n = 100 per group) who received either nicotine patch (21 mg/24 hr) or placebo patch treatment for 2 weeks before the quit smoking date, and during this period, smoked their usual brands of cigarettes or switched to low-tar and nicotine cigarettes: a 2 (nicotine patch) x 2 (cigarette type) factorial design. From the quit date on, all groups received standard nicotine patch treatment, consisting of 6 weeks of 21 mg/24 hr, 2 weeks of 14 mg/24 hr, and 2 weeks of 7 mg/24 hr. Abstinence was defined as self-report of no smoking from the quit date on, confirmed by expired-air carbon monoxide.
                Continuous abstinence rates were approximately doubled by precessation nicotine patch treatment. The treatment mainly benefited smokers with lower levels of dependence, based on Fagerström Test for Nicotine Dependence score. All treatments were well tolerated.
                In view of these findings and similar results from previous studies, current labeling of the nicotine patch, which recommends using nicotine replacement therapy only after the quit date, should be reexamined. Two hundred cigarette smokers in Thailand were randomly assigned to receive a chewing gum containing nicotine or placebo. After six months, significantly more of the group receiving the active gum than those receiving the placebo had given up smoking. The results suggested that this treatment was more effective in highly dependent smokers than in those who were less dependent. Few side effects were reported. We analysed the effectiveness of a high intensity behavioural-cognitive intervention compared to minimal intervention started during a hospital stay, to see if the combination of nicotine replacement therapy (NRT) can increase the quitting rate at 12 months of follow up.
                A total of 2560 active smokers were studied during their hospital stay. Of these, 717 smokers refused to enter the study and after a minimal intervention they were asked if we could telephone them after one year to ask if they still smoked. The remaining 1843 smokers who received high intensity cognitive therapy were randomised to receive or not receive NRT. The follow up after discharge was carried out by outpatient visits or with telephone sessions.
                At one year of follow up, 7% of those who declined to enter the study had stopped smoking compared to 27% of those who entered the study (p<0.001). There were significant differences between the group that only had behavioural therapy (21% stopped) compared to the group that also had NRT (33% stopped; p=0.002). In this latter group there were significant differences (p=0.03) between those who had follow up in clinics (39% stopped) compared to those who were followed up telephone sessions (30%). In the multivariate analysis, the predictors of quitting at 12 months were: to have used NRT (OR 12.2; 95% CI, 5.2-32; p=0.002) and a higher score in the Richmond Test (OR 10.1; 95% CI, 3.9-24.2; p=0.01).
                A cognitive type intervention started on smokers when admitted to hospital increases quitting rates at 12 months, compared to a minimal intervention, and these rates increase even more significantly if NRT is added.
                Copyright © 2010 SEPAR. Published by Elsevier Espana. All rights reserved. To evaluate the efficacy and safety of orally administered naltrexone, alone or in combination with nicotine patches, as a treatment for cigarette smoking.
                Randomized, partially-blinded, 2 x 2 factorial trial using naltrexone (active vs. placebo) and nicotine patches (active vs. none).
                One hundred cigarette smokers.
                Twelve weeks of either placebo-only, naltrexone-only, placebo with nicotine patches or naltrexone with nicotine patches. The naltrexone dose was 50 mg taken once daily, and the nicotine patch dose was 21 mg/24-hour for the first 8 weeks and 14 mg/24-hour for the remaining 4 weeks. Brief behavioral intervention was provided at each visit.
                One-week point-prevalence smoking abstinence rates confirmed by an expired air carbon monoxide level of 8 parts per million (ppm) or less, daily cigarette smoking and cigarette craving.
                At the end of treatment, there was no effect of naltrexone on smoking abstinence. The smoking abstinence rates were 19% and 22% for the placebo only and naltrexone only treatment groups, respectively, and 48% and 46% for the placebo with nicotine patch and naltrexone with nicotine patch groups, respectively. However, the effect of the nicotine patch at this time was significant (p = 0.006), but not at the 6-month follow-up. No significant effect of naltrexone was observed on daily cigarette smoking on cigarette craving during the study.
                The opioid antagonist naltrexone was not found to be effective for smoking cessation and had no significant effect on daily cigarette consumption or craving. The results of the present study provide no support for the use of naltrexone, alone or in combination with nicotine patches, as a therapeutic treatment for smoking cessation. Effects of a transdermal nicotine substitution on psychological smoking cessation were investigated in a double-blind prospective study. 131 smokers were randomly assigned to three treatment conditions: All smokers underwent nine weeks of self-controlled smoking cessation. During six weeks one group was additionally treated with nicotine patches continuously releasing nicotine through the skin into the blood circuit. The second group received placebo patches; while the third group was treated with behavioral training alone. Treatment effects were measured by daily cigarette consumption. Nicotine-treated subjects reached significantly higher abstinence rates during and at the end of treatment than both placebo- and control-subjects: 69% in the nicotine condition, 51.2% and 44.4% under placebo and control conditions respectively. Effects are influenced by initial cigarette consumption, with the light smokers benefitting most from the nicotine patch. Self-assessments suggest an aversive effect of transdermal nicotine on cigarette taste. Our results, although not yet verified by long-term observations, demonstrate that transdermal nicotine substitution significantly enhances the effectiveness of behavioral smoking cessation methods. The transdermal nicotine patch has proved an effective aid to smoking cessation. The ease of securing good compliance gives it a potential advantage over nicotine gum as an adjunct to brief advice and support in primary care settings where the major public health impact is obtained. In a preliminary report of half the sample of a randomized placebo controlled trial, we showed the patch to be effective in a general practice setting. We report here the definitive results of the full sample, including dose effects, predictors of outcome and other issues of theoretical and practical interest. A total of 1200 heavy smokers (> or = 15 per day), attending 30 general practices in 15 English counties received brief GP advice, a booklet and 16 hours per day patch treatment for 18 weeks. Dose increase and abrupt vs. gradual reduction of patch dosage were also randomized and follow-ups conducted at 1, 3, 6, 12, 26 and 52 weeks. Outcome was measured by self-reported complete abstinence from week 3 to 52 with biochemical validation at all follow-up points. Nicotine patch treatment doubled the rate of continuous abstinence up to 1 year (nicotine 9.6%, placebo 4.8%, p < 0.01); it most likely worked by reducing withdrawal symptoms. It enhanced cessation during the first week and reduced relapse during the second week. The dose increase after week 1 produced no sustained increase in cessation. Gradual reduction was no better at preventing relapse than abrupt withdrawal of patches after week 12. Whether relapse would have increased by ending treatment at some point between weeks 3 and 12 was not tested. Although pre-treatment dependence on cigarettes was prognostic of failure, the patches were equally helpful to both highly and less dependent smokers. Patches were particularly helpful to smokers with pre-treatment subclinical dysthymic symptoms. All but one of the 96 subjects eventually achieving long-term abstinence in the study quit during the first week of cessation. Nicotine replacement therapies have proved to be of value in smoking cessation. However, not all smokers can use the nicotine gum or nicotine patch owing to side effects. In addition, the absorption of nicotine from these formulas is slow compared with smoking. A nicotine nasal spray delivers nicotine more rapidly. The objective of this study was to evaluate the efficacy and safety of the nicotine nasal spray for smoking cessation.
                Subjects were recruited through advertisements in newspapers and among patients referred to the smoking cessation clinic at Sahlgren's Hospital, Göteborg, Sweden. Two hundred forty-eight smokers were treated in small groups with eight counseling sessions over 6 weeks. At their first group session, subjects were randomized to a group receiving nicotine spray (n = 125), 0.5 mg of nicotine per single spray, or to a placebo group (n = 123). The procedure was double blind. Success rates were measured up to 12 months. The nonsmoking status was verified by expired carbon monoxide less than 10 ppm.
                Significantly more subjects in the nicotine group were continuously abstinent for 12 months than in the placebo group (27% vs 15%; odds ratio, 2.16; 95% confidence interval, 1.15 to 4.12). Ten of the 34 abstinent subjects in the nicotine group used the spray for 1 year. Mild or moderate side effects were rather frequent for both sprays, but they were significantly more for the nicotine spray. Subjects with high scores (> 7) on Fagerström's tolerance questionnaire had a significantly lower success rate with placebo than with the nicotine spray. For subjects with low scores, there was no difference.
                Nicotine nasal spray in combination with group treatment is an effective aid to smoking cessation. Of 2110 adult cigarette smokers originally recruited to a study of the effect of antismoking advice in general practice, 429 who reported at follow up after one year that they had tried unsuccessfully to stop smoking were offered "a special antismoking chewing gum," either nicotine gum or a placebo gum, in a double blind study. Of 200 who were willing to try the gum, 101 were randomly allocated to the nicotine gum and 99 to the placebo gum. They were followed up at six months by an unannounced home visit, at which they were interviewed and asked to provide a breath sample for analysis of carbon monoxide. Twenty five claimed that they had stopped smoking, but, of them, seven exhaled levels of carbon monoxide indicative of continued smoking. Of the 18 in whom giving up smoking was validated, 10 had received active gum and eight placebo gum, a difference which was not significant (odds in favour of nicotine gum = 1.25, 95% confidence limits 0.47-3.31). The value of nicotine chewing gum, if any, can be quite small when it is used in general practice. The authors compared the outcome of 208 smokers treated with fixed-dose transdermal nicotine (n = 69), tapered-dose transdermal nicotine (n = 71), or buspirone (n = 68). At baseline, there were no significant differences among the three treatment groups with regard to age, gender, educational level, duration of smoking, number of cigarettes smoked per day, concomitant disease states or drug use, or Fagerstrom score. All smokers participated in a behavior modification program. Fixed-dose transdermal nicotine was given at a dose of 21 or 22 mg/day for 6 weeks. Tapered-dose transdermal nicotine was given at a dose of 21 or 22 mg/day for 4 weeks, 14 mg/day for 4 weeks and 7 mg/day for 4 weeks. Both transdermal nicotine regimens were initiated on the evening before the attempted quit date. Buspirone was started 21 days before the quit attempt and continued for 7 days after the quit attempt. Buspirone was initiated at 5 mg TID for 7 days and then 10 mg TID for 21 days. Smoking cessation was assessed by patient diaries and random plasma thiocyanate determinations. Dropouts for any reason were considered treatment failures. Quit rates were as shown in the Table I. Discontinuation of treatment for perceived side effects and dropouts for all reasons were not significantly different among the treatment groups. The authors conclude that fixed-dose transdermal nicotine, tapered-dose transdermal nicotine, and buspirone are associated with similar efficacy and safety when combined with behavior modification in smoking cessation. The authors examined the effect of 24-hour nicotine patches in smoking cessation among over-the-counter customers in Denmark, based on a randomized double-blind placebo-controlled trial. Participants were consecutive customers to whom nicotine patches were offered as the only treatment. Forty-two pharmacies in the areas of Aarhus and Copenhagen in Denmark participated in the trial, and 522 customers who smoked 10 or more cigarettes per day were randomized to either nicotine patches or placebo from January to March 1994. Customers with chronic diseases and pregnant or breastfeeding women were excluded from the trial. Twenty-four-hour patches were offered free of charge during a 3-month period. Those smoking 20 or more cigarettes per day started on a dose of 21-mg/day patches. Customers who smoked less started on patches of 14 mg/day; and for all of the participants, the dose was gradually reduced to 7-mg/day patches during the study period. Smoking behavior and compliance were recorded by means of self-administered questionnaires and telephone interviews. Smoking status was recorded in intervals of 4 weeks, which was fixed to be a treatment period, and 26 weeks after inclusion. There was a significant increase in smoking cessation rates after 8 weeks of follow-up but only among smokers who started on 21-mg/day patches. There was a marked placebo effect at each time of contact during the trial, especially in those smoking fewer than 20 cigarettes per day. Although the noncompliance rate was high overall due to discontinuation in the use of patches by relapsed smokers, noncompliance among successful quitters was low. More side effects were seen in the nicotine group than in the placebo group, but none of the reported side effects were serious. It appears that regular healthy smokers who were customers of nonprescribed nicotine patches and who received 21-mg/day nicotine patches benefited from the active treatment (44.1% stopped smoking after 4 weeks), but almost as many stopped smoking in the placebo group (37.3% after 4 weeks). No significant differences in smoking cessation rates were seen among smokers who started with the low-dose nicotine or placebo patches. Randomized clinical trial carried out to investigate the effectiveness of the cognitive-behavioral approach and nicotine replacement therapy with nicotine patches for smoking cessation. Participated 1,199 adults, volunteers, in Rio de Janeiro, Brazil, randomly assigned to 10 different groups: intensive brief counseling group (GB), with 1 or 2 sessions (G1-G2), and with 3 or 4 sessions (G3-G4), with/without nicotine replacement therapy (NRT). Abstinence proportions were estimated during 12 months. These proportions among participants not assigned to NRT were 20% (GB), 17% (G1-G2), and 23% (G3-G4); and among assigned NRT groups were 30% (GBA), 34% (G1A-G2A), and 33% (G3A-G4A). After multiple adjustments, the abstinence proportions ratios seemed to follow a "dose-response" pattern: compared to GB, the ratios were 0.85 (G1-G2), 1.13 (G3-G4), 1.51 (GBA), 1.66 (G1A-G2A), and 1.75 (G3A-G4A). The results suggest that use of NRT increases the abstinence proportion for cessation. The "dose-response" pattern suggests that cognitive-behavioral could be the reasonable option in the smoking cessation therapy. To examine the individual effects of supervised and intensive exercise as well as the combined effects of exercise and nicotine replacement therapy (NRT) on (a) smoking cessation and reduction rates and (b) psychological and physiological processes during withdrawal.
                One-hundred and forty-two inactive female smokers were randomised into the following four groups: exercise+nicotine patch; exercise+no nicotine patch; cognitive behavior therapy (CBT)+nicotine patch and CBT+no nicotine patch. Smoking abstinence (verified by saliva cotinine and expired carbon monoxide), cessation self-efficacy, and physical fitness and body weight were assessed at baseline (week 1), quit date (week 6), program termination (week 12), and 3- and 12-month follow-up.
                There were significant differences in a 7-day point prevalence but not continuous abstinence rates between treatment groups across targeted end points. Consistently higher cessation rates were seen when NRT was added to both treatment programs. Compared with CBT participants, exercise participants had significantly increased functional exercise capacity and had gained significantly less weight during program end points but these differences did not hold at a 12-month follow-up. Compared with exercise participants, CBT participants felt greater cessation efficacy and reported greater knowledge, coping and support resources across all end points.
                Exercise combined with NRT facilitates smoking cessation, improves functional exercise capacity, and delays weight gain in women smokers. We recommend that physicians and health care professionals recommend exercise and NRT together for highly motivated women interested in quitting smoking. Improving and targeting nicotine replacement therapy (NRT) are cost-effective strategies for reducing adverse health consequences for smokers. Treatment studies document the efficacy of precessation NRT and support important roles for level of nicotine dependence and precessation smoking reduction in successful quitting. However, prior work has not identified the optimal precessation dose or means for personalizing NRT. Genome-wide association has identified groups of genomic markers associated with successful quitting, allowing us to develop a v1.0 "quit-success" genotype score. We now report influences of v1.0 quit-success genotype score, level of dependence and precessation smoking reduction in a smoking cessation trial that examined effects of 21 versus 42 mg/24 h precessation NRT. Four hundred seventy-nine smokers were randomized to 21 or 42 mg NRT, initiated 2 wks prior to target quit dates. We monitored self-reported abstinence and end-expired air carbon monoxide (CO). Genotyping used Affymetrix arrays (Santa Clara, CA, USA). The primary outcome was 10-wk continuous smoking abstinence. NRT dose, level of nicotine dependence and genotype scores displayed significant interactive effects on successful quitting. Successful abstinence also was predicted by CO reductions during precessation NRT. These results document ways in which smoking cessation strategies can be personalized based on levels of nicotine dependence, genotype scores and CO monitoring. These assessments, taken together, can help match most smokers with optimal NRT doses and help rapidly identify some who may be better treated using other methods. In this double-blind, placebo-controlled smoking cessation treatment study, 608 participants were randomly assigned to receive active bupropion and active 4-mg gum (AA, n = 228), active bupropion and placebo gum (AP, n = 224), or placebo bupropion and placebo gum (PP, n = 156). Relative to the PP group, the AA and AP groups were each significantly more likely to be abstinent at 1 week, end of treatment, and 6 months but not at 12 months postquit. After the first week postquit there were no differences in abstinence rates between the AA and AP groups. We found no significant individual difference variables that moderated outcome beyond 1 week postquit. This study examines whether adding nicotine replacement therapy (NRT) to cognitive-behavioral therapy (CBT) for pregnant smokers increases rates of smoking cessation.
                An open-label randomized trial (Baby Steps, n=181) of CBT-only versus CBT+NRT (choice of patch, gum, or lozenge; 1:2 randomization) was used. Data were collected from 2003 through 2005; analyses were conducted in 2006 and 2007. Outcomes were biochemically validated self-reported smoking status at 7 weeks post-randomization, 38 weeks gestation, and 3 months postpartum.
                Women in the CBT+NRT arm were almost three times more likely than women in the CBT-only arm to have biochemically validated cessation at both pregnancy time points (after 7 weeks: 24% vs 8%, p=0.02; at 38 weeks gestation: 18% vs 7%, p=0.04), but not at 3 months postpartum (20% vs 14%, p=0.55). Recruitment was suspended early by an Independent Data and Safety Monitoring Board when an interim analysis found a higher rate of negative birth outcomes in the CBT+NRT arm than in the CBT-only arm. In the final analysis, the difference between the arms in rate of negative birth outcomes was 0.09 (p=0.26), when adjusted for previous history of preterm birth.
                The addition of NRT to CBT promoted smoking cessation in pregnant women. This effect did not persist postpartum. More data are needed to determine safety parameters and to confirm the efficacy of NRT use during pregnancy. This study was undertaken to assess the safety and efficacy of a treatment involving brief counseling and the nicotine patch among hospital inpatients and to identify variables associated with long-term smoking cessation following hospitalization.
                One hundred eighty-five patients were randomly assigned to one of three smoking cessation interventions: (1) A Minimal Care (MC) condition, consisting of a brief physician-delivered motivational message to stop smoking, (2) a Counseling + Active Nicotine Patch (CAP) condition in which patients received the motivational message, a 6-week supply of nicotine patches, and extended bedside and telephone counseling, and (3) a Counseling + Placebo Patch (CPP) condition identical to the CAP condition except the supplied patches contained no nicotine.
                At 6-month follow-up, abstinence rates for the three treatments were 4.9, 6.5, and 9.7% for the MC, CPP, and CAP treatments, respectively. These differences were not statistically significant. Patients admitted for respiratory disease were more likely to quit than patients with any other diagnosis. The nicotine patch was well tolerated by hospital inpatients.
                The initiation of nicotine patch therapy during hospitalization appears to be safe when used among patients carrying a wide range of diagnoses. Our study provided no evidence of the superiority of nicotine patches versus placebo, but this does not preclude the possibility that future research using larger samples might detect differences between patch groups. Hospital interventions for smoking cessation may be most effective among patients hospitalized for a smoking-related illness such as respiratory disease. To evaluate the efficacy and safety of a transdermal nicotine patch as an aid for smoking cessation in an over-the-counter setting.
                Multicenter, double-blind, randomized, placebo-controlled trial of 6-week duration with 18 weeks of follow-up.
                Four shopping mall precincts.
                The randomized sample consisted of 802 adults (mean age, 39 years) and was 89% white and 54% female. A smoking history of at least 20 cigarettes per day for 1 year and a score of 5 (on a 10-point scale) on a motivational assessment questionnaire were required for enrollment. Poststudy follow-up was limited to those who had quit smoking at the end of 6 weeks.
                Nicotine patches were provided at the shopping mall. Guidance consisted only of package instructions and a smoking cessation self-help booklet.
                Quit rates were defined as total abstinence from smoking for 4 consecutive weeks (treatment weeks 3-6), point prevalence smoking status at week 6, or nonsmoker at week 6 and week 24 (6-month postquit date). Smoking status was assessed by diaries, and verification for the first 2 quit rates was obtained by confirmation of carbon monoxide of 8 ppm or less in expired breath. Safety was evaluated by self-reported adverse events.
                Quit rate was 12% for the active treatment group and 5.5% for the placebo group, based on total abstinence for 4 consecutive weeks (P = .001) compared with quit rates of 19.5% and 7.5% for active treatment and placebo groups, respectively, based on point prevalence data at week 6. At 24 weeks, 8.2% of nonsmokers in the active treatment group and 4.0% in the placebo group remained nonsmokers. At least 1 adverse event was reported by 57% receiving the nicotine patch and 39% receiving placebo (P<.001).
                When the nicotine patch was used in an over-the-counter setting, quit rates were comparable to those reported for medical settings. A 2:1 quit rate advantage was achieved at week 6 and was maintained at 24 weeks. This study assessed the efficacy and safety of a nicotine sublingual tablet in smoking cessation in a randomized, double-blind, placebo-controlled outpatient trial conducted between January 1996 and May 1997. Two hundred and forty-one adult smokers (> or = 10 cigarettes/day for at least 3 years) used nicotine 2-mg sublingual tablet (n = 120) or placebo (n = 121) for up to 6 months (a 3-month treatment period followed by a 3-month tapering period). Subjects who scored <7 on the Fagerström Tolerance Questionnaire used 1 tablet/h (up to maximum of 20/day), whereas subjects who scored (7 used 2 tablets/h (up to maximum of 40/day). Brief counseling was provided at baseline and at all visits. Self-reported abstinence was measured from week 2 onwards, confirmed by expired carbon monoxide (CO) levels <10 ppm at each visit (1, 2, 3 and 6 weeks and 3, 6 and 12 months). After 6 weeks of treatment, CO-validated abstinence rates were 48% in the active group and 23% in the placebo group (p < 0.0001). At the 3-, 6- and 12-month visits, abstinence rates (active vs. placebo) were 33% vs. 17% (p = 0.0046), 21% vs. 11% (p = 0.0304) and 18% vs. 10% (p = 0.0606). Adverse events were mild and transient and reflected those reported with existing nicotine replacement formulations. We concluded that the nicotine 2-mg sublingual tablet was effective as a smoking cessation aid. To assess the level of nicotine replacement, evidence of nicotine toxicity, and withdrawal symptom relief with placebo and 11-, 22-, and 44-mg/d doses of transdermal nicotine. A secondary objective was to assess short- and long-term smoking cessation rates.
                Randomized, double-blind, placebo-controlled inpatient/outpatient trial.
                Seventy-one cigarette smokers stratified according to light (n = 23), moderate (n = 24), and heavy (n = 24) smoking rates.
                After baseline measures were obtained, subjects were randomly assigned to placebo or an 11-, 22-, or 44-mg/d dose of transdermal nicotine and admitted to a special hospital unit for intensive inpatient treatment of nicotine dependence. During the 6-day inpatient stay, daily nicotine and cotinine levels were determined from trough and peak blood samples. Outpatient patch therapy continued for 7 weeks following the hospital stay, and those initially assigned to placebo were randomly assigned to 11 or 22 mg/d. At week 4, the dosage of those initially assigned to 44 mg/d was reduced to 22 mg/d.
                Percentage of replacement of cotinine was calculated by dividing the steady-state levels attained during patch therapy by the corresponding baseline levels. Abstinence from smoking was verified by expired air carbon monoxide. Withdrawal symptoms and nicotine toxicity were assessed daily through questionnaires during the inpatient stay. Follow-up visits were at 3, 6, 9, and 12 months.
                There was a statistically significant relationship between baseline smoking rate and baseline trough and peak blood cotinine levels (rs = 0.39, rs = 0.45; P < .001 in both instances). A dose-response relationship was observed with higher patch doses, which produced a higher percentage of cotinine replacement and better withdrawal symptom relief. Only one subject (a light smoker assigned to the 44-mg dose) developed signs of nicotine toxicity. There was a positive association between the week 2 patch dose and the biochemically confirmed abstinence at the end of patch therapy (P = .007) but not for subsequent follow-up times. A higher percentage of cotinine replacement was associated with the higher 8-week smoking abstinence rate (P = .03), an association not found at long-term follow-up.
                A 44-mg/d dose of nicotine patch therapy appears to be safe for use in heavy smokers. Cigarette smoking rates can be used to estimate the initial nicotine patch dose. Monitoring blood cotinine levels at baseline and steady state can be used for assessing the adequacy of nicotine replacement. Withdrawal symptom relief can be improved with more complete nicotine replacement. Achieving a greater percentage of nicotine replacement may increase the efficacy of nicotine patch therapy. nan This study was designed to see whether the offer and prescription of nicotine chewing gum would enhance the efficacy of general practitioners' advice to stop smoking. A sample of 1938 cigarette smokers who attended the surgeries of 34 general practitioners in six group practices were assigned by week of attendance (in a balanced design) to one of three groups: (a) non-intervention controls, (b) advice plus booklet, and (c) advice plus booklet plus the offer of nicotine gum. Follow up was done after four months and one year. The results show a clear advantage for those offered the nicotine gum (p less than 0.001). After correction for those who refused or failed chemical validation and those who switched from cigarettes to a pipe or cigars, the proportions who were abstinent at four months and still abstinent at one year were 3.9%, 4.1%, and 8.8% in the three groups, respectively. These percentages are based on all cigarette smokers who attended the surgeries including those who did not wish to stop and those in the gum group who did not try the gum (47%). The effect of the offer and prescription of gum was to motivate more smokers to try to stop, to increase the success rate among those who tried, and to reduce the relapse rate of those who stopped. The self selected subgroup of 8% who used more than one box of 105 pieces of gum achieved a success rate of 24%. It would be feasible and effective for general practitioners to include the offer of nicotine gum and brief instructions on its use as part of a minimal intervention routine with all cigarette smokers. A general practitioner who adopts such a routine with similar success could expect to achieve about 35-40 long term ex-smokers a year and so save the lives of about 10 of them. If replicated by all general practitioners throughout the country the yield of ex-smokers would be about one million a year. Seventy-eight smokers trying to quit were randomly assigned to 0-, 0.5-, 2- and 4-mg doses of nicotine gum and tracked for 9 months. In the 1st week of abstinence, self-administration of gum did not differ by dose (4 mg = 2 mg = 0.5 mg = 0 mg). Higher doses did not more effectively suppress withdrawal than lower doses nor induce more accurate nicotine identification (4 mg = 2 mg = 0.5 mg greater than 0 mg). Higher doses slightly increased ratings of adverse effects in the 1st week (4 mg greater than 2 mg greater than 0.5 mg greater than 0 mg). Over the next 6 months, the two higher doses appeared to support more gum self-administration than the two lower doses (4 mg = 2 mg greater than 0.5 mg = 0 mg) in the subsample of long-term quitters (n = 20). Our results suggest the dose-response curves differ for nicotine gum's reinforcing, withdrawal-suppression and self-reported effects. To evaluate the efficacy of a new nicotine inhaler system for smoking cessation.
                A 1-year, randomized, double-blind, placebo-controlled study.
                Medical outpatient clinic with physicians experienced in smoking cessation assistance.
                A total of 286 volunteers who smoked at least 10 cigarettes daily recruited through a local newspaper.
                Subjects were randomly allocated to nicotine inhalers (n = 145) or placebo (n = 141) to be used for 3 months followed by tapering for 3 months in the context of minimal levels of advice and support.
                Continuous smoking abstinence at weeks 6, 12, 24, and 52, verified by measurements of carbon monoxide in expired air.
                Continuous smoking abstinence was significantly higher for the active nicotine inhaler group compared with the placebo inhaler group. The respective success rates were 28% and 12% after 6 weeks, 21% and 9% after 12 weeks, 17% and 8% after 6 months, and 15% and 5% after 1 year (P = .02 to .001). The mean nicotine substitution based on cotinine determinations after 2 weeks was 43% (SD, 45%) of smoking levels. The treatment was well tolerated, and no serious adverse events were reported.
                In this setting the nicotine inhaler appeared safe to use and increased success rates of smoking cessation attempts. We used the Heaviness of Smoking Index, a subset of the Fagerstrom Test for Nicotine Dependence, to classify 608 cigarette smokers planning a cessation attempt as low or high in nicotine dependence. Subjects within each level of dependence were then randomly assigned to placebo, 2-mg, or 4-mg nicotine gum treatment. Subjects were also provided brief (5-10 min per visit) behavioral counseling during a 1-year period of follow-up. At 1 year post-cessation, quit rates were 11.2, 19.5, and 18.4% for low-dependence smokers receiving placebo, 2-mg, and 4-mg gum, respectively (plinear trend = 0.20). For high-dependence smokers, quit rates at 1 year were 6.1, 15.7, and 20.7% for the placebo, 2-mg, and 4-mg gum conditions, respectively (plinear trend = 0.002). The interaction of nicotine-gum dose and dependence group was not significant (p = 0.42), nor did the 2-mg and 4-mg doses differ significantly in effectiveness, though both 2-mg and 4-mg gum were significantly more effective than placebo gum. We also found a significant dose-related effect for nicotine gum to moderate post-cessation heart-rate decline. Other variables related to abstinence at 1 year post-cessation were a longer period of abstinence on a prior quit attempt, being married, higher education level, and having a non-smoking spouse or significant other. Results indicate that nicotine gum is a significant aid to smoking cessation, more than doubling the odds of successful cessation compared to the odds for placebo-gum users. The 4-mg dose provided a non-significant increase in cessation rates for high-dependence smokers. Smoking history and demographic variables also have a significant impact on the outcome of a quit-smoking attempt. This study determined whether higher dose nicotine patches are more efficacious than lower dose patches among heavy smokers. A randomized double-blind study compared 0, 21, 35, and 42 mg/day of a 24-h patch in 1039 smokers (> or = 30 cigarettes/day) at 12 clinical sites in the USA and one in Australia. Daily patches were used for 6 weeks followed by tapering over the next 10 weeks. Weekly group therapy occurred. Biochemically validated self-reported quit rates at 6, 12, 26, and 52 weeks post-cessation were measured. Quit rates were dose-related at all follow-ups (p < 0.01). Continuous, biochemically verified abstinence rates for the 0, 21, 35, and 42 mg doses at the end of treatment (12 weeks) were 16, 24, 30, and 39%. At 6 months, the rates were 13, 20, 20, and 26%. Among the 11 sites with 12 month follow-up (n = 879), the quit rates were 7, 13, 9, and 19%. In post-hoc tests, none of the active doses were significantly different from each other at any follow-up. The rates of dropouts due to adverse events for 0, 21, 35, and 42 mg were 3, 1, 3, and 6% (p = n.s.). Our results are similar to most prior smaller studies; i.e., in heavy smokers higher doses increase quit rates slightly. Longer durations of treatment may be necessary to show greater advantages from higher doses. The purpose of this study was to determine the efficacy and safety of the nicotine patch for smoking cessation in an over-the-counter environment. The years of study were 1994 to 1995.
                Parallel 6-week trials were conducted: a placebo-controlled trial of no-cost 22-mg, 24-hour nicotine patch therapy and an open label trial of the same therapy with patches purchased by subjects. Participants (n = 958) were 18 years or older, had smoked at least 15 cigarettes daily for at least 6 months, and were enrolled at 3 study sites. The main outcome measure was self-reported smoking abstinence confirmed by expired carbon monoxide measurements.
                Smoking cessation rates in the placebo-controlled trial were 16.8% and 9.6% at week 6 and 8.7% and 4.3% at week 24 for the active patch and placebo groups, respectively. Smoking cessation rates in the open label-pay trial were 19.0% and 10.8% at weeks 6 and 24, respectively. A slight increase in adverse cardiovascular events was noted only in the open label-pay group in comparison with the placebo group.
                In an over-the-counter environment, the 22-mg, 24-hour nicotine patch is effective and safe for smoking cessation treatment.