Behavioral counseling and varenicline treatment for smoking cessation. A smoking cessation intervention for the methadone-maintained. Weekly versus basic smoking cessation support in primary care: a randomised controlled trial. Short- and long-term smoking cessation for three levels of intensity of behavioral treatment. A randomized controlled clinical trial of bupropion SR and individual smoking cessation counseling. Varying nicotine patch dose and type of smoking cessation counseling. Integrating smoking cessation treatment into primary care: an effectiveness study. Cognitive-behavioral intervention increases abstinence rates for depressive-history smokers. Comparison of two intensities of tobacco dependence counseling in schizophrenia and schizoaffective disorder. Smoking cessation in military personnel. Nortriptyline and cognitive-behavioral therapy in the treatment of cigarette smoking. Is telephone counselling a useful addition to physician advice and nicotine replacement therapy in helping patients to stop smoking? A randomized controlled trial. The effect of a minimal intervention strategy in addition to nicotine replacement therapy to support smoking cessation in cardiovascular outpatients: a randomized clinical trial. Effectiveness of pharmacotherapy and behavioral interventions for smoking cessation in actual clinical practice. Comparing smoking treatment programs for lighter smokers with and without a history of heavier smoking. Extended cognitive behavior therapy for cigarette smoking cessation. Effect of varying levels of disease management on smoking cessation: a randomized trial. Telephone support as an adjunct to transdermal nicotine in smoking cessation. Nurse-conducted smoking cessation in patients with COPD using nicotine sublingual tablets and behavioral support. Proactive recruitment of health plan smokers into telephone counseling. The effectiveness and cost effectiveness of telephone counselling and the nicotine patch in a state tobacco quitline. Effectiveness of bupropion sustained release for smoking cessation in a health care setting: a randomized trial. [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]. Nicotine gum and behavioral treatment in smoking cessation. Nicotine gum and behavioral treatment: a placebo controlled trial. The effect of a culturally tailored smoking cessation for Chinese American smokers. Telephone counselling as an adjunct to nicotine patches in smoking cessation: a randomised controlled trial. Psychological intervention and antidepressant treatment in smoking cessation. Intensive smoking cessation counseling versus minimal counseling among hospitalized smokers treated with transdermal nicotine replacement: a randomized trial. Free nicotine patches plus proactive telephone peer support to help low-income women stop smoking. Motivation and patch treatment for HIV+ smokers: a randomized controlled trial. Does extended proactive telephone support increase smoking cessation among low-income women using nicotine patches? Extended treatment of older cigarette smokers. Strike while the iron is hot: can stepped-care treatments resurrect relapsing smokers? Results of two levels of adjunctive treatment used with the nicotine patch. Partner support, psychological treatment, and nicotine gum in smoking treatment: an incremental study.
Smoking remains the primary preventable cause of death and illness in the U.S. Effective, convenient treatment programs are needed to reduce smoking prevalence.
                This study compared the effectiveness of three modalities of a behavioral smoking-cessation program in smokers using varenicline.
                Current treatment-seeking smokers (n=1202) were recruited from a large healthcare organization between October 2006 and October 2007. Eligible participants were randomized to one of three smoking-cessation interventions: web-based counseling (n=401); proactive telephone-based counseling (PTC; n=402); or combined PTC and web counseling (n=399). All participants received a standard 12-week FDA-approved course of varenicline. Self-report determined the primary outcomes (7-day point prevalent abstinence at 3- and 6-month follow-ups); the number of days varenicline was taken; and treatment-related symptoms. Behavioral measures determined utilization of both the web- and Phone-based counseling.
                Intent-to-treat analyses revealed relatively high percentages of abstinence at 3 months (38.9%, 48.5%, 43.4%) and at 6 months (30.7%, 34.3%, 33.8%) for the web, PTC, and PTC-web groups, respectively. The PTC group had a significantly higher percentage of abstinence than the web group at 3 months (OR=1.48, 95% CI=1.12, 1.96), but no between-group differences in abstinence outcomes were seen at 6 months.
                Phone counseling had greater treatment advantage for early cessation and appeared to increase medication adherence, but the absence of differences at 6 months suggests that any of the interventions hold promise when used in conjunction with varenicline.
                2010 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved. To test, in combination with the nicotine patch, the incremental efficacy of a maximal, tailored behavioral treatment over a minimal treatment for smoking cessation.
                Randomized clinical trial with 6-month follow-up.
                Five methadone maintenance treatment centers in Rhode Island.
                Three hundred and eighty-three methadone-maintained smokers.
                Participants were assigned randomly to nicotine patch (8-12 weeks) plus either (1) a baseline tailored brief motivational intervention, a quit date behavioral skills counseling session and a relapse prevention follow-up session (Max) or (2) brief advice using the National Cancer Institute's 4 As model (Min). An intent-to-treat analysis with those lost to follow-up assumed to smoke was used.
                Carbon monoxide (CO)-confirmed 7-day point smoking cessation prevalence at 3 and 6 months, and self-reported numbers of cigarettes smoked per day.
                Participants had a mean age of 40 years, were 53% male, 78% Caucasian, smoked 26.7 (+/- 12.2) cigarettes/day and had a mean methadone dose of 95.5 mg. At 3 months, 317 (83%) were re-interviewed; at 6 months, 312 (82%) were re-interviewed. The intent-to-treat, 7-day point prevalence estimate of cessation was 5.2% in the Max group and 4.7% in the Min group (P=0.81) at 6 months. In logistic models with treatment condition, age, gender, race, Fagerström Test for Nicotine Dependence and cigarettes per day as covariates, males were more likely to be abstinent at 3 months (OR 4.67; P=0.003) and 6 months (OR 4.01; P=0.015).
                A tailored behavioral intervention did not increase quit rates over patch and minimal treatment. Smoking cessation rates in methadone-maintained smokers are low, with men having greater success. There is insufficient and conflicting evidence about whether more intensive behavioural support is more effective than basic behavioural support for smoking cessation and whether primary care nurses can deliver effective behavioural support.
                A randomised controlled trial was performed in 26 UK general practices. 925 smokers of >or=10 cigarettes per day were randomly allocated to basic or weekly support. All participants were seen before quitting, telephoned around quit day, and seen 1 and 4 weeks after the initial appointment (basic support). Participants receiving weekly support had an additional telephone call at 10 days and 3 weeks after the initial appointment and an additional visit at 2 weeks to motivate adherence to nicotine replacement and renew quit attempts. 15 mg/16 h nicotine patches were given to all participants. The outcome was assessed by intention to treat analyses of the percentage confirmed sustained abstinence at 4, 12, 26 and 52 weeks after quit day.
                Of the 469 and 456 participants in the basic and weekly arms, the numbers (%) who quit and the percentage difference were 105 (22.4%) vs 102 (22.4%), 0.1% (95% CI -5.3% to 5.5%) at 4 weeks, 66 (14.1%) vs 52 (11.4%), -2.6% (95% CI -6.9% to 1.7%) at 12 weeks, 50 (10.7%) vs 40 (8.8%), -1.9% (95% CI -5.7% to 2.0%) at 26 weeks and 36 (7.7%) vs 30 (6.6%), -1.1% (95% CI -4.4% to 2.3%) at 52 weeks.
                The absolute quit rates achieved are those expected from nicotine replacement alone, implying that neither basic nor weekly support were effective. Primary care smoking cessation treatment should provide pharmacotherapy with sufficient support only to ensure it is used appropriately, and those in need of support should be referred to specialists. Efficacy and costs of 3 levels of medical-behavioral treatment intensity in conjunction with nicotine replacement therapy (NRT) were compared in 240 one-pack-a-day smokers: (a) a low-intensity (LI) group that received 8 weeks of NRT (n = 80) and 1 advice and education (A&E) session with a nurse practitioner (NP); (b) a moderate-intensity (MI) group that was provided NRT and 4 A&E sessions with an NP (n = 80); and (c) a high-intensity (HI) group that received treatment combining NRT, 4 A&E sessions, and 12 weeks of individualized cognitive-behavioral therapy (n = 80). Biochemically confirmed abstinence rates at 9, 26, and 52 weeks posttreatment initiation were highest for the HI (45%, 37%, 35%) group, followed by the LI (35%, 30%, and 27%) and MI (27%, 12%, 12%) groups. Group differences approached statistical significance at 9 weeks and were statistically significant at both 26 and 52 weeks. The cost of LI treatment was $308, that of MI was $338, and the HI treatment cost was $582. Efficacy of bupropion SR and individual counseling as smoking cessation treatments was assessed in a randomized, placebo-controlled clinical trial among adult daily smokers. Bupropion SR treatment and counseling were fully crossed in this factorial design so that the efficacy of each treatment and the combination could be estimated, relative to a placebo medication and assessment control condition. Intent-to-treat analyses indicated that bupropion SR increased abstinence rates at the end of treatment, relative to the placebo medication conditions, for both biochemically confirmed 7-day point-prevalence abstinence (OR = 1.97, 95% CI 1.04-3.72) and self-reported prolonged abstinence (OR = 2.90, 95% CI 1.66-5.06). Bupropion SR treatment also improved latency to lapse and relapse and improved the latency between lapse and relapse in survival analyses. Medication effects were more modest for both 12-month point-prevalence abstinence (OR = 1.47, 95% CI 0.74-2.92) and prolonged abstinence (OR = 1.34, 95% CI 0.66-2.72). Counseling was not associated with increases in the likelihood of abstinence at any time point (odds ratios ranged from 0.80 to 1.16 across abstinence outcomes in the full intent-to-treat sample). Counseling and medication did not significantly interact at any time point, and adding counseling did not improve end-of-treatment point-prevalence abstinence (OR = 1.17, 95% CI 0.68-2.03) or prolonged abstinence (OR = 1.26, 95% CI 0.75-2.12) substantially when offered in conjunction with active medication. 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. Lack of interest has been cited as a reason not to offer cessation assistance to smokers, but research suggests that smokers accept treatments offered proactively. This study assessed acceptability, utilization, and effectiveness of free smoking cessation treatment among diverse primary care patients.
                Medical assistants invited 4174 adult smokers to participate. Enrollees (1869) self-selected or were assigned to receive free nicotine patch therapy alone or in combination with the Committed Quitters(R) program, and for some, individual counseling.
                In nearly 68% of cases, patients accepted a treatment invitation; 77% of eligible smokers enrolled; 85% of these picked up free patches. Given a choice of treatments, 75% of participants elected a psychosocial treatment in addition to patch therapy. Thirteen percent of treatment initiators achieved biochemically confirmed 7-day point-prevalence abstinence at 1 year, with no significant treatment effects. Minority patients showed greater initial interest but less utilization did than White patients.
                Free, readily accessible smoking cessation treatment offered in primary care settings was accepted and used by the majority of unselected smokers of diverse racial/ethnic origins. Psychosocial treatment components did not significantly increase abstinence rates. Barriers, rather than lack of interest, may keep minority smokers from using cessation treatments. This article describes the test of the hypothesis that a cognitive-behavioral mood management intervention would be effective for smokers with a history of major depressive disorder (MDD). The method was randomized trial; the assessments occurred at Weeks 0, 8, 12, 26, and 52. Ss were 149 smokers; 31% had a history of MDD. All received 2 mg of nicotine gum. Mood management was provided in 10 group sessions over 8 weeks. Standard treatment was provided in 5 group sessions over 8 weeks. Outcome was continuous abstinence. History-positive Ss were more likely to be abstinent when treated with mood management. Treatment condition differences were not significant for history-negative Ss. For history-positive Ss, less anger at baseline predicted abstinence. For history-negative Ss, more years smoked and higher baseline carbon monoxide (CO) predicted abstinence. Cognitive-behavioral therapy did not affect mood after quitting. Abstinence predictors differed as a function of baseline diagnosis. Compared to the general population, smokers with schizophrenia (SCZ) have reduced success in quitting smoking with usual approaches. This study tested two manualized behavioral counseling approaches-Treatment of Addiction to Nicotine in Schizophrenia (TANS) or Medication Management (MM)-for smokers who were motivated to quit. Individual counseling sessions were provided by mental health clinicians in mental health settings, along with nicotine patch. The two treatments varied in intensity and frequency of sessions. Eighty-seven subjects were randomized and attended at least one treatment session. Twenty-one percent (n = 18) of participants had continuous abstinence at 12 weeks after the target quit date, which was not significantly different between conditions (15.6% TANS vs. 26.2% MM, chi(2) = 1.50, p = .221). Smokers in both groups significantly reduced smoking as measured by cigarettes per day and expired carbon monoxide. Findings support that mental health clinicians can be trained to effectively help smokers with SCZ maintain tobacco abstinence.
                Copyright 2010 Elsevier Inc. All rights reserved. Tobacco use is the single most important preventable cause of death in military personnel. The purpose of this randomized clinical trial was to evaluate the effectiveness of two behavioral interventions when added to nicotine-replacement therapy on smoking cessation. The sample of 512 included 52% active duty military, 29% family, 11% retirees, and 8% Department of Defense civilians. There was a main effect of compliance at the end of the program (EOP); 69% of those who attended 75% of the classes were abstinent from tobacco; regression analysis found the more intensive program to be twice as effective at EOP and at 3 months, an outcome not continued at 6 months. The longer, more intensive Vanderbilt University Medical Center program was significantly more effective at helping the civilian portion of the population (85% versus 60% in the American Cancer Society program) but not the active duty participants. A history of major depressive disorder (MDD) predicts failure to quit smoking. We determined the effect of nortriptyline hydrochloride and cognitive-behavioral therapy on smoking treatment outcome in smokers with a history of MDD. The study also addressed the effects of diagnosis and treatment condition on dysphoria after quitting smoking and the effects of dysphoria on abstinence.
                This was a 2 (nortriptyline vs placebo) x 2 (cognitive-behavioral therapy vs control) x 2 (history of MDD vs no history) randomized trial. The participants were 199 cigarette smokers. The outcome measures were biologically verified abstinence from cigarettes at weeks 12, 24, 38, and 64. Mood, withdrawal, and depression were measured at 3, 5, and 8 days after the smoking quit date.
                Nortriptyline produced higher abstinence rates than placebo, independent of depression history. Cognitive-behavioral therapy was more effective for participants with a history of depression. Nortriptyline alleviated a negative affect occurring after smoking cessation. Increases in the level of negative affect from baseline to 3 days after the smoking quit date predicted abstinence at later assessments for MDD history-negative smokers. There was also a sex-by-depression history interaction; MDD history-positive women were less likely to be abstinent than MDD history-negative women, but depression history did not predict abstinence for men.
                Nortriptyline is a promising adjunct for smoking cessation. Smokers with a history of depression are aided by more intensive psychosocial treatments. Mood and diagnosis interact to predict relapse. Increases in negative affect after quitting smoking are attenuated by nortriptyline. The authors evaluated the incremental efficacy of telephone counselling by a nurse in addition to physician advice and nicotine replacement therapy in helping patients to stop smoking.
                The trial was conducted at the University of Ottawa Heart Institute. A total of 396 volunteers who smoked 15 or more cigarettes daily were randomly assigned to either of 2 groups: usual care (control group) and usual care plus telephone counselling (intervention group); the groups were stratified by sex and degree of nicotine dependence. Usual care involved the receipt of physician advice on 3 occasions, self-help materials and 12 weeks of nicotine replacement therapy. Telephone counselling was provided by a nurse at 2, 6 and 13 weeks after the target quit date. Point-prevalent quit rates were determined at 52 weeks after the target quit date.
                The point-prevalent quit rates at 52 weeks did not differ significantly between the control and intervention groups (24.1% v. 23.4% respectively). The quit rates did not differ significantly at the secondary measurement points of 4, 12 and 26 weeks.
                Brief physician assistance, along with nicotine replacement therapy, can help well-motivated smokers to quit. Three additional sessions of telephone counselling by a nurse were ineffective in increasing quit rates. This form of assistance may be useful in the absence of physician advice or when self-selected by patients. Smoking is an important risk factor for recurrent events in cardiovascular patients. Evidence exists that nicotine replacement therapy (NRT) approximately doubles smoking cessation rates. The minimal intervention strategy (MIS) has been used successfully to assist patients to quit smoking in general practice, and was recently adapted for cardiology inpatients (C-MIS). It is hypothesized that in cardiovascular outpatients the combination of C-MIS and NRT significantly increases the number of quitters compared to NRT alone.
                A randomized clinical trial in 385 smoking patients who attended the cardiovascular outpatient departments in the Academic Medical Centre, Amsterdam for the treatment of atherosclerotic disease. Patients were allocated to either NRT + C-MIS or NRT alone. Self-reported and biochemically validated abstinence rates were measured at 12 months' follow-up.
                Including patients with incomplete follow-up as smokers, abstinence was reported by 19% of the NRT + C-MIS group and 14% of the NRT group [absolute risk reduction (ARR) = 0.05; 95% confidence interval (CI) = -0.02; 0.12]. According to biochemical markers, abstinence rates were 28 and 24%, respectively (ARR = 0.04, 95% CI = -0.06; 0.14). Hence, no significant differences between groups were found. The number of cigarettes smoked a day decreased significantly at 12 months: from 21 to 15 a day in the experimental group, and from 21 to 14 in the control group (P<0.001), but did not differ between groups (P=0.32).
                The effectiveness of a minimal contact intervention was investigated in order to reach as many cardiovascular patients as possible in the setting of outpatient departments. This intervention was not found to be effective. This study evaluated the effectiveness of behavioral interventions (brief counseling, nonspecific psychological support in groups - NSGS and cognitive behavioral group therapy - CBGT) in combination with bupropion SR for smoking cessation in the field, through a smoking cessation clinic.
                Two-hundred-and-five smokers were enrolled in a 19-week course during 2007/ 2008, and were randomly assigned to: bupropion SR combined with brief counseling (group A), bupropion SR combined with NSGS (group B), bupropion SR combined with CBGT (group C), or CBGT as the only approach (group D).
                Continuous abstinence rates at the end of therapy were 53.2% for group A, 62.9% for group B, 50.0% for group C, and 22.2% (p < 0.05) for group D. Sustained abstinence rates in 12 months were 29.6%, 28.1%, 34.3% and 19.4% (p > 0.05), respectively.
                Bupropion SR is an effective aid for smoking cessation in clinical practice. NSGT increased the chances for success at the end of therapy when combined with bupropion SR, while CBGT as monotherapy was less effective compared with the approaches including pharmacotherapy. It is suggested that smoking cessation interventions in real-life healthcare settings should be implemented through comprehensive programs using pharmacotherapy where applicable, combined with NSGT, and integrated by specialized healthcare professionals. 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. PRIMARY AIM: Examine the effectiveness of extended cognitive behavior therapy (CBT) in promoting longer-term smoking abstinence.
                Open-label treatment phase followed by extended treatment phase. Randomization conducted prior to entry into open-label treatment phase; analysis based on intention-to-treat to avoid threat of selection bias.
                Community smoking cessation clinic.
                A total of 304 adult smokers (> or = 18 years of age; > or = 10 cigarettes/day).
                Open-label (8 weeks): all participants received bupropion SR, nicotine patch, CBT. Extended treatment (12 weeks): participants received either CBT + voicemail monitoring and telephone counseling or telephone-based general support.
                Seven-day point prevalence abstinence, expired-air carbon monoxide.
                At week 20 follow-up, CBT produced a higher 7-day point prevalence abstinence rate: 45% versus 29%, P = 0.006; at 52 weeks the difference in abstinence rates (31% versus 27%) was not significant. History of depression was a moderator of treatment. Those with a positive history had a better treatment response at 20 weeks when assigned to the less intensive telephone support therapy (P < 0.05).
                The superiority of CBT to 20 weeks suggests that continued emphasis on the development of cognitive and behavioral strategies for maintaining non-smoking during an extended treatment phase may help smokers to maintain abstinence in the longer term. At present, the minimum duration of therapy is unknown. Cigarette smoking is a chronic, relapsing illness that is inadequately addressed in primary care practice.
                To compare cessation rates among smokers who receive pharmacotherapy alone or combined with either moderate- or high-intensity disease management that includes counseling and provider feedback.
                Randomized clinical trial from June 2004 to December 2007.
                50 rural primary care practices.
                750 persons who smoke more than 10 cigarettes per day.
                Pharmacotherapy alone (n = 250), pharmacotherapy supplemented with up to 2 counseling calls (moderate-intensity disease management) (n = 249), or pharmacotherapy supplemented with up to 6 counseling calls (high-intensity disease management) (n = 251). Interventions were offered every 6 months for 2 years. All participants were offered free pharmacotherapy. Moderate-intensity and high-intensity disease management recipients had postcounseling progress reports faxed to their physicians.
                Self-reported, point-prevalence smoking abstinence at 24 months (primary outcome) and overall (0 to 24 months) analyses of smoking abstinence, utilization of pharmacotherapy, and discussions about smoking with physicians (secondary outcomes). Research assistants who were blinded to treatment assignment conducted outcome assessments.
                Pharmacotherapy utilization was similar across treatment groups, with 473 of 741 (63.8%), 302 of 739 (40.9%), 175 of 732 (23.9%), and 179 of 726 (24.7%) participants requesting pharmacotherapy during the first, second, third, and fourth 6-month treatment cycles, respectively. Of participants who saw a physician during any given treatment cycle, 37.5% to 59.5% reported that they had discussed smoking cessation with their physician; this did not differ across the treatment groups. Abstinence rates increased throughout the study, and overall (0 to 24 months) analyses demonstrated higher abstinence among the high-intensity disease management group than the moderate-intensity disease management group (odds ratio [OR], 1.43 [95% CI, 1.00 to 2.03]) and among the combined disease management groups than the pharmacotherapy-alone group (OR, 1.47 [CI, 1.08 to 2.00]). Self-reported abstinence at 24 months was 68 of 244 (27.9%) and 56 of 238 (23.5%) participants in the high- and moderate-intensity disease management groups, respectively (OR, 1.33 [CI, 0.88 to 2.02]), and 56 of 244 (23.0%) participants in the pharmacotherapy-alone group (OR, 1.12 [CI, 0.78 to 1.61] for combined disease management vs. pharmacotherapy alone).
                The effect of pharmacotherapy management cannot be separated from the provision of free pharmacotherapy, and cessation was validated in only 58% of self-reported quitters.
                Smokers are willing to make repeated pharmacotherapy-assisted quit attempts, leading to progressively greater smoking abstinence. Although point-prevalence abstinence did not differ at 24 months, analyses that incorporated assessments across the full 24 months of treatment suggest that higher-intensity disease management is associated with increased abstinence.
                National Cancer Institute. Transdermal nicotine patches have shown considerable promise in improving smoking cessation outcomes. The present study assessed telephone support as an adjunct to a managed care-based, single-session group orientation smoking cessation program with nicotine patch therapy.
                The unit of randomization was the orientation session (n = 35). Subjects (n = 509) were randomly assigned to a group session without telephone support, the session plus access to a toll-free help line, or the session with telephone help line plus active telephone outreach.
                Contrary to hypothesis, there were no differences between treatment conditions. Overall abstinence rates were 22% at 6 months and 21% at 1 year. Fewer than 1% of eligible subjects called the toll-free help line. An average of 3.8 of a possible 4 calls were completed in the telephone outreach condition.
                Abstinence results obtained in this program were comparable to those obtained with more extensive counseling. However, there was no evidence of benefit from telephone support beyond the initial physician-led group orientation session. 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. We tested whether a 3-month beneficial effect of telephone counseling as an adjunct to the use of medications for smoking cessation was maintained through 12 months. Health plan members filling a prescription for cessation medications were randomized either to a no-contact control group or to proactive recruitment into telephone counseling. An increased point-prevalence quit rate at 3 months (33.1% vs. 27.4%, p<.05) among smokers randomized to proactive recruitment for telephone counseling was not maintained. Although at 12 months smokers in the proactive recruitment arm were more likely to report a 24-hr quit attempt, compared with control group smokers (86.7% vs. 80.8%, p = .027), we found no differences between the groups in repeated (3-month and 12-month) 7-day point-prevalence quit rates. In an analysis of predictors of quitting, age, marital status, making a lifestyle change, and the presence of household smokers were associated with repeated 3-month and 12-month point-prevalence abstinence. Offering telephone counseling to insured smokers who have filled prescriptions for cessation medications did not increase long-term quit rates. Although other variations of this approach might be tested, we suspect that it might be more useful to test innovative ways to influence the factors we identified as being most strongly predictive of lack of successful quitting. State and national tobacco quitlines have expanded rapidly and offer a range of services. We examined the effectiveness and cost effectiveness of offering callers single session versus multisession counselling, with or without free nicotine patches.
                This 3x2 randomised trial included 4614 Oregon tobacco quitline callers and compared brief (one 15-minute call), moderate (one 30-minute call and a follow-up call) and intensive (five proactive calls) intervention protocols, with or without offers of free nicotine patches (nicotine replacement therapy, NRT). Blinded staff assessed tobacco use by phone at 12 months.
                Abstinence odds ratios were significant for moderate (OR = 1.22, CI = 1.01 to 1.48) and intensive (OR = 1.29, CI = 1.07 to 1.56) intervention, and for NRT (OR = 1.58, CI = 1.35 to 1.85). Intent to treat quit rates were as follows: brief no NRT (12%); brief NRT (17%); moderate no NRT (14%); moderate NRT (20%); intensive no NRT (14%); and intensive NRT (21%). Relative to brief no NRT, the added costs for each additional quit was $2467 for brief NRT, $1912 for moderate no NRT, $2109 for moderate NRT, $2641 for intensive no NRT, and $2112 for intensive NRT.
                Offering free NRT and multisession telephone support within a state tobacco quitline led to higher quit rates, and similar costs per incremental quit, than less intensive protocols. The efficacy of bupropion hydrochloride sustained release (SR) (Zyban) for smoking cessation has been evaluated in clinical trials that included frequent in-person behavioral counseling, but not in actual practice settings.
                To determine the differential effectiveness of 2 doses of bupropion SR in combination with behavioral interventions of minimal to moderate intensity in an actual practice setting.
                Open-label randomized trial, with 1 year of follow-up.
                A large health system (Group Health Cooperative) based in Seattle.
                Adult smokers (N = 1524) interested in quitting smoking.
                Participants were randomly assigned to receive 1 of 4 combinations of bupropion SR (150 or 300 mg) and behavioral counseling (minimal or moderate intensity).
                The primary outcome measure was self-reported point-prevalence 7-day nonsmoking status at 3 and 12 months following the target quit date. Secondary outcomes included adverse and abstinence effects reported since beginning treatment with bupropion SR.
                At 3 months, a significantly higher rate of nonsmoking was observed among those receiving the larger bupropion SR dose (P=.005). At 12 months, moderate intensity counseling was associated significantly with a higher rate of nonsmoking (P=.001). At 3 months, the higher dose was associated with a significantly increased frequency of self-reported symptoms such as difficulty sleeping (P=.02), difficulty concentrating (P=.02), shakiness/tremor (P=.002), and gastrointestinal problems (P=.005)and a decreased frequency of reported desire to smoke (P=.001).
                In this actual practice setting, the combination of bupropion SR and minimal or moderate counseling was associated with 1-year quit rates of 23.6% to 33.2%. This suggests that existing health care systems can substantially decrease tobacco use rates among their enrollees if they provide these modest interventions. 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. nan nan Tobacco use is a serious public health problem among low-income Chinese Americans with limited English proficiency. Chinese men are at high risk for smoking-related morbidity and mortality. We tested the feasibility of a culturally and linguistically sensitive smoking intervention program with combined counseling and pharmacological components for Chinese smokers in New York City; identified factors and techniques that enhance the administration and appropriateness of the intervention program; and examined the overall impact of this program on quit attempts, quit rates, and overall smoking reduction.
                We were guided by the transtheoretical model and used an adapted motivational interviewing (MI) approach. The study involved a randomized sample with pretreatment assessment and multiple follow-up measures. Eligible participants (N = 122) were randomly assigned to intervention (4 individualized counselor-led MI sessions and nicotine replacement therapy [NRT]) or control groups (4 general health education sessions, self-help materials, and NRT).
                Quit rate at 6 months in the intervention group was 67% versus 32% for the control group, indicating minimal relapse and a highly successful intervention program. Increase in self-efficacy and decease in pros of smoking from baseline to 6-month follow-up were positively associated with smoking cessation. The number of cigarette smoked at baseline was inversely related to smoking cessation. Results indicate that a combined intensive behavioral counseling and pharmacological intervention can reduce smoking substantially.
                The results of this pilot will be used as a basis for a large-scale randomized trial of an intervention with combined culturally and linguistically sensitive MI and NRT components for Chinese and other Asian ethnic groups. To investigate the effectiveness of telephone counselling as an adjunct to nicotine replacement therapy (NRT) by transdermal patch in smoking cessation.
                Randomised controlled trial.
                854 smokers from New South Wales, aged 18 years and older, who had smoked at least 10 cigarettes per day for the past year and responded to newspaper advertisements between October 2001 and January 2002; the trial was conducted between October 2001 and August 2002.
                Random allocation to either NRT alone or NRT plus telephone counselling (5 sessions spaced according to a relapse-sensitive call schedule).
                Self-reported abstinence assessed by telephone questionnaires at 1, 2, 3 and 6 months: 28-day continuous abstinence at 3 and 6 months, and 90-day continuous abstinence at 6 months.
                28-day continuous abstinence rates among participants receiving telephone counselling were significantly greater than among those not receiving telephone counselling at both 3 and 6 months (31.6% v 25.1%; P = 0.04 at 3 months; and 30.1% v 22.4%; P = 0.01 at 6 months). Similarly, 90-day continuous abstinence rates at 6 months were significantly greater for participants receiving counselling (26.7% v 18.6%; P = 0.004).
                Telephone counselling as an adjunct to NRT increases abstinence rates beyond the use of NRT alone. Sustained-release bupropion hydrochloride and nortriptyline hydrochloride have been shown to be efficacious in the treatment of cigarette smoking. It is not known whether psychological intervention increases the efficacy of these antidepressants. This study compared both drugs with placebo. It also examined the efficacy of these 2 drugs and placebo with and without psychological intervention.
                This was a 2 (medical management vs psychological intervention) x 3 (bupropion vs nortriptyline vs placebo) randomized trial. Participants were 220 cigarette smokers. Outcome measures were biologically verified abstinence from cigarettes at weeks 12, 24, 36, and 52.
                Psychological intervention produced higher 7-day point-prevalence rates of biochemically verified abstinence than did medical management alone. With the use of point-prevalence abstinence, both nortriptyline and bupropion were more efficacious than placebo. On rates of 1-year continuous abstinence, the 2 drugs did not differ from each other or from placebo. Psychological intervention did not differ from medical management alone on rates of 1-year continuous abstinence.
                Both nortriptyline and bupropion are efficacious in producing abstinence in cigarette smokers. Similarly, psychological intervention produces better abstinence rates than simple medical management. Both drugs, and psychological intervention, have limited efficacy in producing sustained abstinence. The data also suggest that combined psychological intervention and antidepressant drug treatment may not be more effective than antidepressant drug treatment alone. To determine whether an intensive cognitive-behavioral intervention begun during hospitalization when combined with transdermal nicotine replacement therapy is more effective than a minimal counseling intervention combined with transdermal nicotine replacement therapy in helping inpatients to quit smoking.
                A total of 223 patients who smoked were enrolled in a hospital-based randomized smoking cessation trial at the San Francisco Veterans Affairs Medical Center. One hundred and seven participants (48%) received intensive counseling and outpatient telephone follow-up; 116 participants (52%) received minimal counseling. All study participants received 2 months of transdermal nicotine replacement therapy. We determined 6-month quit rates by self-report and measured saliva cotinine levels or obtained proxy reports to confirm self-reported smoking cessation at 12 months. Analyses adjusted for baseline differences in the distribution of coronary disease.
                At 6 months, 35% (36/103) of the intensive intervention group reported quitting, compared with 21% (23/109) of the comparison group (relative risk [RR] = 1.7; 95% confidence interval [CI]: 1.1 to 2.7). At 12 months, the self-reported quit rate was 33% (33/99) in the intensive intervention group versus 20% (21/103) in the comparison group (RR = 1.7; 95% CI: 1.1 to 2.7). Based on biochemical or proxy confirmation, 29% (30/102) in the intensive intervention group versus 20% (21/107) in the comparison group quit smoking at 12 months (RR = 1.6; 95% CI: 0.96 to 2.5).
                Hospital-initiated smoking cessation interventions that include transdermal nicotine replacement therapy can improve long-term quit rates. This study tested the impact of free nicotine patches plus proactive telephone peer support to help low-income women stop smoking.
                A total of 214 Medicaid-eligible women smokers of childbearing age were randomized to receive free nicotine patches through the mail or free nicotine patches through the mail plus the provision of proactive support by telephone from a woman ex-smoker for up to 3 months. Assessments were conducted by telephone at baseline, 10 days, and 3 and 6 months after enrollment.
                At the 3-month follow-up, significantly more women in the patch plus proactive telephone support condition were abstinent (42%) compared to the patch only condition (28%) (P = 0.03). Similarly, more women in the experimental condition were abstinent at both the 10-day and 3-month assessments (32 v 19%, P = 0.02). However, differences were not found at the 6-month follow-up, suggesting that the addition of proactive telephone peer support enhanced short-term, but not long-term cessation.
                This is the first study to demonstrate a beneficial effect for the addition of proactive telephone support as an adjunct to free nicotine replacement in a low-income population.
                Copyright 2000 American Health Foundation and Academic Press. To test the efficacy of two smoking cessation interventions in a HIV positive (HIV+) sample: standard care (SC) treatment plus nicotine replacement therapy (NRT) versus more intensive motivationally enhanced (ME) treatment plus NRT.
                Randomized controlled trial.
                HIV+ smoker referrals from eight immunology clinics in the northeastern United States.
                A total of 444 participants enrolled in the study (mean age = 42.07 years; 63.28% male; 51.80% European American; mean cigarettes/day = 18.27).
                SC participants received two brief sessions with a health educator. Those setting a quit date received self-help quitting materials and NRT. ME participants received four sessions of motivational counseling and a quit-day counseling call. All ME intervention materials were tailored to the needs of HIV+ individuals.
                Biochemically verified 7-day abstinence rates at 2-month, 4-month and 6-month follow-ups.
                Intent-to-treat (ITT) abstinence rates at 2-month, 4-month and 6-month follow-ups were 12%, 9% and 9%, respectively, in the ME condition, and 13%, 10% and 10%, respectively, in the SC condition, indicating no between-group differences. Among 412 participants with treatment utilization data, 6-month ITT abstinence rates were associated positively with low nicotine dependence (P = 0.02), high motivation to quit (P = 0.04) and Hispanic American race/ethnicity (P = 0.02). Adjusting for these variables, each additional NRT contact improved the odds of smoking abstinence by a third (odds ratio = 1.32, 95% confidence interval = 0.99-1.75).
                Motivationally enhanced treatment plus NRT did not improve cessation rates over and above standard care treatment plus NRT in this HIV+ sample of smokers. Providers offering brief support and encouraging use of nicotine replacement may be able to help HIV+ patients to quit smoking. It is unclear whether proactive telephone support enhances smoking cessation beyond the provision of nicotine replacement therapy alone.
                We randomly assigned 330 low-income women smokers to receive either free nicotine patches (control condition) or free nicotine patches with up to 16 weeks of proactive telephone support (experimental condition). All participants were assessed by telephone at baseline and at 2 weeks, 3 months, and 6 months post-baseline to determine smoking status.
                Results revealed a significant effect for the telephone support at 3 months, with 43% of experimental versus 26% of control condition women reporting 30-day point prevalent abstinence (P = 0.002). The difference was no longer significant at 6 months. A metaanalysis conducted with five randomized studies revealed a slight but non-significant long-term benefit of proactive telephone support when added to the provision of free nicotine patches for smoking cessation.
                This is the second study to demonstrate a short-term effect for proactive telephone support added to free nicotine replacement therapy; however, neither the current study, nor the metaanalysis including the four other published trials, confirmed a longer-term benefit. Tobacco dependence treatments achieve abstinence rates of 25-30% at 1 year. Low rates may reflect failure to conceptualize tobacco dependence as a chronic disorder. The aims of the present study were to determine the efficacy of extended cognitive behavioral and pharmacological interventions in smokers > or = 50 years of age, and to determine if gender differences in efficacy existed.
                Open randomized clinical trial.
                A free-standing, smoking treatment research clinic.
                A total of 402 smokers of > or = 10 cigarettes per day, all 50 years of age or older.
                Participants completed a 12-week treatment that included group counseling, nicotine replacement therapy (NRT) and bupropion. Participants, independent of smoking status, were then assigned randomly to follow-up conditions: (i) standard treatment (ST; no further treatment); (ii) extended NRT (E-NRT; 40 weeks of nicotine gum availability); (iii) extended cognitive behavioral therapy (E-CBT; 11 cognitive behavioral sessions over a 40-week period); or (iv) E-CBT plus E-NRT (E-combined; 11 cognitive behavioral sessions plus 40 weeks nicotine gum availability).
                Primary outcome variable was 7-day point prevalence cigarette abstinence verified biochemically at weeks 24, 52, 64 and 104.
                The most clinically important findings were significant main effects for treatment condition, time and the treatment x time interaction. The E-CBT condition produced high cigarette abstinence rates that were maintained throughout the 2-year study period [(week 24 (58%), 52 (55%), 64 (55%) and 104 (55%)], and was significantly more effective than E-NRT and ST across that period. No other treatment condition was significantly different to ST. No effects for gender were found.
                Extended cognitive behavioral treatments can produce high and stable cigarette abstinence rates for both men and women. NRT does not add to the efficacy of extended CBT, and may hamper its efficacy. Research is needed to determine if these results can be replicated in a sample with a greater range of ages, and improved upon with the addition of medications other than NRT. The efficacies of 2 group counseling step-up treatments for smoking cessation, cognitive-behavioral/skill training therapy (CBT) and motivational interviewing/supportive (MIS) therapy, were compared with brief intervention (BI) treatment in a sample of 677 smokers. Differential efficacy of the 2 step-up treatments was also tested in smokers at low and high risk for relapse (no smoking vs. any smoking during the first postquit week. respectively). All participants received 8 weeks of nicotine patch therapy. BI consisted of 3 brief individual cessation counseling sessions; CBT and MIS participants received BI treatment and 6 group counseling sessions. Neither CBT nor MIS treatment improved long-term abstinence rates relative to BI. Limited support was found for the hypothesis that high-risk smokers would benefit more from MIS than CBT. Other hypotheses were not supported. The authors compared 9-, 16-, 26-, and 52-week outcomes for two randomly assigned groups of nicotine-dependent subjects: 1) nicotine patch plus four smoking cessation sessions with a nurse-practitioner giving advice and instruction (n = 36; moderate-intensity condition, MI); or 2) the foregoing treatments plus 16 weekly individual cognitive/ behavioral relapse-prevention therapy sessions (n = 33; high-intensity condition, HI). Patch completion rates were 69.7% in the HI group and 55.6% in the MI group (NS). Self-reported abstinence rates at the four follow-up points were comparable for the two treatment groups; HI: 39%, 36%, 36%, and 36%; MI: 44%, 28%, 25%, and 28%, respectively. There was some indication that MI patients with high nicotine dependence had lower abstinence rates than highly dependent HI patients. Smokers (N = 99) were randomly assigned to one of three conditions: nicotine gum (NG), nicotine gum plus psychological treatment (NG-PT), and nicotine gum plus psychological treatment and partner support (NG-PT-PS). Data were collected at Weeks 0, 4, 12, 26, and 52 from study start. Contrary to expectations, NG-PT-PS and NG-PT failed to increase abstinence rates. Subjects who were closer to their support partners had significantly lower abstinence rates with NG-PT-PS than with the other conditions, although not significantly at Weeks 26 and 52. Treatments without partner participation (NG-PT and NG) were significantly more effective for subjects who had an extremely close support partner outside the treatment setting than for those who did not at all weeks. The role of social support in smoking treatment is discussed.
Providing behavioural support in person or via telephone for people using pharmacotherapy to stop smoking has a small but important effect. Increasing the amount of behavioural support is likely to increase the chance of success by about 10 to 25%, based on a pooled estimate from 38 trials. A subgroup analysis of a small number of trials suggests the benefit could be a little greater when the contrast is between a no contact control and a behavioural intervention that provides at least four sessions of contact. Subgroup analysis also suggests that there may be a smaller incremental benefit from providing even more intensive support via more or longer sessions over and above some personal contact.