Both smoking reduction with nicotine replacement therapy and motivational advice increase future cessation among smokers unmotivated to quit. Smoking reduction with oral nicotine inhalers: double blind, randomised clinical trial of efficacy and safety. Efficacy of the nicotine inhaler in smoking reduction: A double-blind, randomized trial. Long-term results of a smoking reduction program. Cigarette reduction: an intervention for adolescent smokers. Effect of smoking reduction on later cessation: a pilot experimental study. Smoking reduction fails to improve clinical and biological markers of cardiac disease: a randomized controlled trial. Smoking cessation or reduction with nicotine replacement therapy: a placebo-controlled double blind trial with nicotine gum and inhaler. A 12-month, randomized, controlled study to evaluate exposure and cardiovascular risk factors in adult smokers switching from conventional cigarettes to a second-generation electrically heated cigarette smoking system. Smoking reduction treatment with 4-mg nicotine gum: a double-blind, randomized, placebo-controlled study. Computer and manual self-help behavioral strategies for smoking reduction: initial feasibility and one-year follow-up. Evaluation of biomarkers of exposure to selected cigarette smoke constituents in adult smokers switched to carbon-filtered cigarettes in short-term and long-term clinical studies. Smoking reduction intervention in a large population-based study. The Inter99 study. Postintervention effect of nicotine replacement therapy on smoking reduction in smokers who are unwilling to quit: randomized trial. Smoking reduction promotes smoking cessation: results from a double blind, randomized, placebo-controlled trial of nicotine gum with 2-year follow-up. A randomized, controlled exposure study in adult smokers of full flavor Marlboro cigarettes switching to Marlboro Lights or Marlboro Ultra Lights cigarettes. Effects of sustained-release bupropion among persons interested in reducing but not quitting smoking.
Smokers not currently interested in quitting (N = 616) were randomized to receive telephone-based (a) reduction counseling plus nicotine replacement therapy (NRT) plus brief advice to quit, (b) motivational advice plus brief advice, or (c) no treatment. More smokers in the reduction (43%) and motivational (51%) conditions made a 24-hr quit attempt over 6 months than smokers in the no-treatment condition (16%; p < or = .01), but the 2 active conditions did not differ (p > or = .05). Similarly, 18%, 23%, and 4% of each condition were abstinent (7-day point prevalence) at 6 months (p < or = .01). Results indicate smoking reduction using NRT does not undermine cessation but rather increases the likelihood of quitting to a degree similar to motivational advice.
                (c) 2004 APA, all rights reserved 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. Many smokers are not ready to quit but are interested in changing their smoking behavior, particularly if such a change is associated with a reduction in health risk. The present study evaluated the efficacy of the nicotine inhaler in reducing smoking. Exploratory studies assessed whether reduction in smoking was associated with reduction in markers of disease risk. A total of 429 healthy smokers (smoking at least 20 cigarettes/day) were randomly assigned to either nicotine-containing or placebo inhalers, which subjects were allowed to use ad libitum for up to 1 year. The nicotine inhaler was significantly superior to placebo in achieving reduction in daily cigarette consumption by at least 50% after 4 months, compared with baseline (18% vs. 8%, p = .004). Active treatment promoted smoking cessation: 8% of subjects in the nicotine group and 1% in the placebo group were abstinent at month 15. Throughout the study, smoking reduction, per se, independent of treatment group, was associated with a statistically significant decrease in exhaled carbon monoxide and serum cotinine and thiocyanate. Smoking reduction also improved established risk markers for cardiovascular disease over 4 months. The incidence of adverse events did not differ significantly between the active and placebo groups. The most common treatment-related adverse events were throat irritation and cough. In conclusion, the nicotine inhaler can help smokers who are unable or unwilling to quit to reduce daily cigarette consumption, which may be a health benefit on its own and may further promote quitting. There have been few comprehensive evaluations of smoking reduction, especially in health care delivery systems, and little is known about its cost, maintenance of reduced smoking, or robustness across patient subgroups.
                A generally representative sample of 320 adult smokers from an HMO scheduled for outpatient surgery or a diagnostic procedure was randomized to enhanced usual care or a theory-based smoking reduction intervention that combined telephone counseling and tailored newsletters. Outcomes included cigarettes smoked, carbon monoxide levels, and costs.
                Both intervention and control conditions continued to improve from 3- to 12-month assessments. Between-condition differences using intent-to-treat analyses on both self-report and carbon monoxide measures were nonsignificant by the 12-month follow-up (25% vs. 19% achieved 50% or greater reductions in cigarettes smoked). The intervention was implemented consistently despite logistical constraints and was generally robust across patient characteristics (eg, education, ethnicity, health literacy, dependence).
                In the absence of nicotine replacement therapy, the long-term effects of this smoking reduction intervention seem modest and nonsignificant. Future research is indicated to enhance intervention effects and conduct more comprehensive economic analyses of program variations. This observational study examined whether adolescents who were not interested in quitting could reduce cigarette smoking and if cigarette reduction led to a corresponding and significant reduction in biomarkers of exposure. The study design was a randomized, open-label trial of nicotine patch and nicotine gum with an added placebo control. Participants (n=103) attended 4 treatment visits over 4 weeks and follow-up visits at 3- and 6-months. Participants were told to reduce their smoking by 25% of baseline smoking during the 1st week and by 50% of baseline smoking during the subsequent 3 weeks. Of consented participants, 91.3% (n=94/103) completed the study until the end-of-treatment, 85.1% (n=80/94) completed the 3-month follow-up visit and 71.3% (n=67/94) completed the 6-month follow-up visit. Participants had a very high prevalence of co-morbidity. With regard to the percentage of participants who achieved a 50% reduction of baseline smoking, there were no significant differences among treatment groups (p=.89). At the end-of-treatment, 49.4% of participants (n=41) had reduced smoking by at least 50%. Additionally, there was no significant group, visit or interaction effect of a biomarker measure for carcinogen exposure (p>.05). The results suggest that reduction may be a potential aid to engage adolescents who are unable or unwilling to quit, but should not be an end goal. The effect of treatment methods on outcome measures did not differ significantly. It is unclear whether reducing the number of cigarettes in smokers not trying to quit increases or decreases the likelihood of future quitting. In a pilot study, smokers not currently interested in quitting (n=67) were randomized to two groups. Experimental participants received behavioral treatment and nicotine replacement therapy (choice of gum, patch, or inhaler) to reduce smoking by 50% over 4 weeks, followed by brief advice to quit. Usual-care participants received only brief advice to quit and nicotine replacement if they decided to quit. During the 4-week treatment period, nonabstaining reduction participants decreased from 23 to 14 cigarettes per day (p<.01) and maintained their reduction over the 6-month follow-up period. At the 6-month follow-up, 35% of usual-care and 41% of reduction participants (nonsignificant [ns]) moved forward in their stage of change. Over the 6 months, 34% of usual-care participants had at least one 24-h quit attempt, compared with 25% of reduction participants (ns). A total of 9% of usual-care participants remained quit at 6 months vs. 13% in the reduction group (ns). These preliminary results suggest that adding a reduction option neither increases nor undermines interest in cessation. Higher than expected rates of attempted cessation and quitting in the usual-care group suggest that we recruited smokers whose motivation to quit was above average. Thus, a replication test in a less-motivated group of smokers is needed. Cigarette reduction has been proposed as a treatment goal for smokers who are not interested in stopping completely. This randomized controlled trial was designed to determine the effect of a smoking reduction intervention on smoking behavior, symptoms of heart disease, and biomarkers of tobacco exposure. It included 152 patients with heart disease who did not intend to stop smoking in the next 30 days. Participants were randomly assigned to smoking reduction (SR) or usual care (UC). SR subjects received counseling and nicotine replacement therapy to encourage > or =50% reduction in cigarettes per day (CPD). They were followed at 1, 3, 6, 12 and 18 months to assess smoking, heart disease symptoms, quality of life and nicotine, cotinine, carbon monoxide (CO), white blood cell (WBC) count, fibrinogen, hs-C-reactive protein (hs-CRP), F2-isoprostane, 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol and its glucuronides (total NNAL), and 1-hydroxypyrene (1-HOP). At 6 months SR participants reduced by 10.9 CPD, compared with 7.4 CPD in UC (difference NS). At 18 months, 9/78 SR vs. 9/74 UC participants quit smoking. There were no significant differences between treatment groups in angina, quality of life or adverse events, nicotine, cotinine, CO, WBC count, fibrinogen, hs-CRP, F2-isoprostane, total NNAL or 1-HOP levels at any time point. To determine if smoking reduction, regardless of treatment condition, was associated with improved outcomes, we compared all subjects at 6 months to baseline (mean reduction in CPD from 27.4 to 18.1, p<.01). There were no significant changes in outcome variables except CO, which decreased by 5.5 ppm (p<.01). There were also no significant improvements considering only subjects who reduced by > or =50%, or those who had no history of reduction prior to enrollment in the study. The SR intervention did not significantly reduce CPD or toxin exposure, or improve smoking cessation or clinical outcomes compared to UC. These results emphasize the importance of abstinence for smokers with heart disease to minimize health risks from tobacco. Even with effective smoking cessation medications, many smokers are unable to abruptly stop using tobacco. This finding has increased interest in smoking reduction as an interim step towards complete cessation.
                This multi-center, double-blind placebo-controlled study evaluated the efficacy and safety of nicotine 4 mg gum or nicotine 10 mg inhaler in helping smokers (N = 314) to reduce or quit smoking. It included smokers willing to control their smoking, and participants could set individual goals, to reduce or quit. The study was placebo-controlled, randomized in a ratio of 2:1 (Active:Placebo), and subjects could choose inhaler or gum after randomization. Outcome was short-term (from Week 6 to Month 4) and long-term (from Month 6 to Month 12) abstinence or reduction. Abstinence was defined as not a single cigarette smoked and expired CO readings of <10 ppm. Smoking reduction was defined as a reduction in number of cigarettes per day by 50% or more versus baseline, verified by a lower-than-baseline CO reading at each visit during the same periods.
                Significantly more smokers managed to quit in the Active group than in the Placebo group. Sustained abstinence rates at 4 months were 42/209 (20.1%) subjects in the Active group and 9/105 (8.6%) subjects in the Placebo group (p = 0.009). Sustained abstinence rates at 12 months were 39/209 (18.7%) and 9/105 (8.6%), respectively (p = 0.019). Smoking reduction did not differ between the groups, either at short-term or long-term. Twelve-month reduction results were 17.2% vs. 18.1%, respectively. No serious adverse events were reported.
                In conclusion, treatment with 10 mg nicotine inhaler or 4 mg nicotine chewing gum resulted in a significantly higher abstinence rate than placebo. In addition a large number of smokers managed to reduce their cigarette consumption by more than 50% compared to baseline. This randomized, controlled, forced-switching, open-label, parallel-group study in 97 adult male and female smokers of conventional cigarettes evaluated biomarkers of tobacco smoke exposure and cardiovascular risk factors. After baseline measurements, smokers were either switched to a second-generation electrically heated cigarette smoking system (EHCSS) or continued smoking conventional cigarettes for 12 months. Biomarkers of exposure and cardiovascular risk factors were measured at 0.5, 1, 2, 3, 4, 5, 6, 9, and 12 months. There was a rapid and sustained reduction in all biomarkers of exposure after switching to the EHCSS, with statistically significant reductions from baseline in nicotine equivalents (-18%), plasma cotinine (-16%), total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (-73%), total 1-hydroxypyrene (-53%), urine mutagenicity (-52%), 4-aminobiphenyl hemoglobin adducts (-43%), carboxyhemoglobin AUC7-23 h (-80%), and 3-hydroxypropylmercapturic acid (-35%). These reductions in exposure in the EHCSS group were associated with statistically significant and pathophysiologically favorable changes in several cardiovascular risk factors, including white blood cell count (-0.78 x 10(3)/microL), hemoglobin (-0.16 g/dL), hematocrit (-0.44%), urine 11-dehydrothromboxane B2 (-374 ng/24 h), and high-density lipoprotein cholesterol (+5 mg/dL). Smoking reduction may provide a harm-reduction alternative treatment for smokers who are not ready to quit smoking. This study evaluated the efficacy of nicotine gum in helping smokers reduce or quit smoking.
                This randomized, double-blind, placebo-controlled trial involved 364 smokers who were not ready to quit but were willing to reduce their smoking intensity. Participants received either 4-mg nicotine gum (n = 184) or placebo gum (n = 180) as desired for up to 12 months. The primary outcome was sustained smoking reduction, which was defined as a decrease in daily cigarette consumption of at least 50% compared with baseline. Secondary measures included point-prevalence abstinence, intention to quit, and cardiovascular risk markers.
                At 4 months, the sustained smoking reduction rate in the nicotine gum group was twice that of the placebo group (15.8% versus 6.7%, P = .008). Point-prevalence abstinence was 6.6% for the nicotine gum group and 2.2% for the placebo group (P = .07). At 13 months, there was a significant difference in the smoking reduction rate for the nicotine (8.2%) and placebo (2.8%) groups (P = .036). At month 13, the abstinence rates were 12% and 4.5% for the nicotine and placebo groups, respectively (P = .012). Concomitant use of nicotine gum and cigarette smoking was well tolerated. Carbon monoxide levels decreased significantly (P = .01).
                Nicotine gum may be an efficacious harm-reduction alternative for smokers who are not ready to quit and may promote smoking cessation, the ultimate goal in the treatment of tobacco dependence. This study sought to test the feasibility of two self-help behavioral interventions to reduce and maintain a 50% reduction in smoking among those unable or unwilling to quit, and to evaluate the impact of smoking reduction on subsequent quit attempts. Ninety-three smokers who desired to reduce rather than quit smoking were entered in the study and randomly assigned to either computerized scheduled gradual reduction (CSGR) or to a manual-based selective elimination reduction (SER). Both groups produced significant reductions in smoking (approximately 10 cigarettes per day, during the 7-week treatment phase), which were maintained over one year. The CSGR group reported greater mean percent reductions in smoking from pre- to post-treatment (37% for CSGR, 20% for SER) and a greater percentage of subjects meeting the 50% reduction goal (30% for CSGR, 16% for SER) compared with the SER group. The groups were comparable, however, on all other outcome measures at post-treatment and at 6- and 12-month follow-up. Although subjects with a current desire for smoking cessation were excluded from this study, one-third of the subjects reported a 24-hour quit attempt in the year following study initiation, and 8.6% of the subjects met 7-day point-prevalence criteria for abstinence (CO validated) at the 12-month follow-up. The results of this study lend support to the feasibility of self-help behavioral interventions to produce sustained reductions in smoking rates without apparent negative impact on subsequent quit attempts. Cigarette smoke is a complex aerosol that includes a gas vapor phase and a particulate phase. Inclusion of activated carbon in the cigarette filter can reduce some of the gas-phase smoke constituents implicated as toxicologically relevant. The present study evaluated exposure to selected gas-phase constituents when adult smokers switched to prototype cigarettes with a highly activated carbon filter. Smokers (N = 160) in two separate studies were randomized to continue to smoke conventional cigarettes (either a 6-mg or 11-mg FTC tar product), to smoke test cigarettes containing carbon filters (comparable tar levels), or to stop smoking. After completing 8 days in controlled smoking conditions (short-term studies), smokers had the option to continue in 24-week long-term ambulatory studies with unrestricted smoking. Urinary excretion of mercapturic acid metabolites of 1,3-butadiene, acrolein, and benzene; nicotine and five of its metabolites, total NNAL, and 1-hydroxypyrene were measured at baseline in the conventional cigarette group, in all groups in the short-term studies, and every 4 weeks in the long-term studies. In the short-term studies, statistically significant reductions (>70%, p<.001) in gas-phase biomarker levels were observed in the test cigarette group for both tar level products compared with the conventional cigarette group. These reductions were similar to those observed in the stop-smoking groups. The reductions continued consistently (p<.001) throughout the long-term studies. Switching to test cigarettes minimally affected the particulate-phase biomarkers. Statistically significant and consistent reductions in selected gas vapor phase biomarkers were observed when smokers switched to activated carbon filter cigarettes. Smoking reduction has been introduced as an alternative to smokers unable or unwilling to quit but has never been implemented in a population-based intervention.
                Two thousand four hundred eight daily smokers in all motivational stages were included in a randomised population-based intervention study, in Copenhagen, Denmark. Smokers, unwilling or unable to quit, were encouraged to reduce their tobacco consumption. Furthermore, smokers in the high-intensity intervention were offered participation in smoking reduction groups.
                Twenty-three percent of those who attended both baseline and 1 year visit reported reduction by at least 5 g and 8% reported a halving or more. Halving of tobacco consumption was achieved significantly more often than in the background population, OR = 2.6 (1.6-4.4), even when assuming that non-participants had not reduced, OR = 1.7 (1.0-2.8). Reduction of at least 5 g doubled the probability of increased motivation to quit and a halving increased it more than four times. The reductions were not validated. Less than 2% attended the smoking reduction groups.
                The smoking reduction intervention was significant in self-reported reduction of tobacco consumption and subsequently increased motivation to quit. This may open new perspectives, with reduction as a first step towards cessation, a possible supplement to smoking cessation strategies. The objective of this study was to assess the post-intervention effect of nicotine replacement therapy on reduction of cigarette consumption 1.5 years after the end of a 6-month treatment. Heavy smokers who had no intention of quitting smoking were recruited from the general population and were randomly assigned to a treatment of nicotine (choice of a 15-mg nicotine patch, a 4-mg nicotine gum, and/or a 10-mg nicotine inhaler, n = 265), matching placebo products (n = 269), or no intervention (n = 389). Products were sent to participants by mail. Education was limited to a booklet. Of 923 participants, 879 (95%) were followed 6 months after randomization and 846 (92%) were followed after 26 months. Mean baseline consumption was 30 cigarettes/day in all groups. After 6 months, cigarette consumption had decreased by a mean of 10.9 cigarettes/day in the nicotine group, 8.7 in the placebo group, and 4.9 among controls (P < or = 0.02 for all pairwise comparisons). After 26 months, compared with baseline, cigarette consumption had decreased by a mean of 9.8 cigarettes/day in the nicotine group, 7.7 in the placebo group, and 7.7 among controls (nicotine vs. placebo or control: P < or = 0.03). After 2 years, smoking cessation rates did not differ significantly among groups (nicotine 11.7%, placebo 9.3%, control, 10.0%; P = 0.6). Thus, a slight effect of nicotine replacement therapy on reduction of cigarette consumption was maintained 1.5 years after the end of the 6-month treatment, but the initially observed placebo effect was not maintained. Nicotine replacement therapy for smoking reduction had no deleterious impact on smoking cessation. 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. Rationale. To date no state-of-the-art clinical study has been conducted to address the question as to whether switching to lower tar cigarettes reduces exposure to smoke constituents in humans. Methods. Randomized, controlled, forced switching study in 225 adult smokers of full flavor Marlboro (MFF) cigarettes for 8 days with a 24-week follow-up. Subjects smoked MFF (a 15-mg Federal Trade Commission (FTC) tar cigarette) at baseline and were randomized to smoke 11-mg Marlboro Lights (ML) or 6-mg Marlboro Ultra Lights (MUL) cigarettes. Biomarkers of exposure to nicotine, 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK), pyrene, CO, benzene, acrolein, and mutagenic substances were measured. Results. In the short-term phase, switching from MFF to ML showed statistically significant decreases in nicotine exposure (-13%) and non-significant increases in CO exposure (+6%), while switching from MFF to MUL showed statistically significant decreases in nicotine (-27%) and CO (-13%) exposure. Both nicotine and CO biomarkers trended similarly in the 24-week follow-up as in the short-term phase. The other biomarkers of cigarette smoke constituents followed the same trend as nicotine at the end of the 24-week follow-up. Conclusions. Switching smokers to lower FTC tar yield cigarettes, on average, reduces nicotine and other biomarkers considered surrogates of tar exposure. To determine whether sustained-release bupropion promotes smoking reduction leading to smoking cessation among persons who wish to reduce their amount of smoking, but who are unwilling to quit or who perceive themselves as being unable to quit.
                Current smokers were assigned randomly to receive either sustained-release bupropion (150 mg twice daily) or matching placebo. During an initial 6-month smoking reduction phase, those who were willing to quit entered a 7-week cessation phase, during which study medication was continued.
                Four-week continuous abstinence rates were 14% (41/295) in the bupropion group and 8% (25/299) in the placebo group (P = 0.02) during treatment. However, this benefit did not continue after treatment was stopped; subsequent continuous abstinence rates were 7% (20/295) in the bupropion group and 5% (16/299) in the placebo group (P = 0.50). Similar proportions of subjects entered the cessation phase in both treatment groups (38% [n = 113] of those in the bupropion group and 34% [n = 101] of those in the placebo group), although the time until a cessation attempt was shorter for those taking bupropion (median, 64 days vs. 118 days, P = 0.008). The extent of smoking reduction (measured by urinary cotinine concentrations) among the 327 subjects who did not enter the cessation phase was significantly greater (P <0.05) in those treated with bupropion during the reduction treatment phase, but not during the month 12 follow-up visit (P = 0.25).
                Sustained-release bupropion, when used in smokers initially not willing to make a cessation attempt, can help sustain smoking reduction while subjects are on active medication, reduce the time until the next cessation attempt, and increase short-term abstinence rates. However, these benefits were modest and not sustained after bupropion was discontinued.
There is insufficient evidence about long-term benefit to support the use of interventions intended to help smokers reduce but not quit smoked tobacco use. Some people who do not wish to quit can be helped to cut down the number of cigarettes smoked and reduce their CO levels by using nicotine gum or nicotine inhaler. Because the long-term health benefit of a reduction in smoking rate is unclear, but is likely to be small, this application of NRT is more appropriately used as a precursor to quitting.