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Should all smokers use combination smoking cessation pharmacotherapy? Using novel analytic methods to detect differential treatment effects over 8 weeks of pharmacotherapy.

ABSTRACT: Combination pharmacotherapy for smoking cessation has been shown to be more effective than monotherapy in meta-analyses. We address the question of whether combination pharmacotherapy should be used routinely with smokers or if some types of smokers show little or no benefit from combination pharmacotherapy versus monotherapy.Two smoking cessation trials were conducted using the same assessments and medications (bupropion, nicotine lozenge, nicotine patch, bupropion + lozenge, and patch + lozenge). Participants were smokers presenting either to primary care clinics in southeastern Wisconsin for medical treatment (Effectiveness trial, N = 1,346) or volunteering for smoking cessation treatment at smoking cessation clinics in Madison and Milwaukee, WI (Efficacy trial, N = 1,504). For each trial, decision tree analyses identified variables predicting outcome from combination pharmacotherapy versus monotherapy at the end of treatment (smoking 8 weeks after the target quit day).All smokers tended to benefit from combination pharmacotherapy except those low in nicotine dependence (longer latency to smoke in the morning as per item 1 of the Fagerström Test of Nicotine Dependence) who also lived with a spouse or partner who smoked.Combination pharmacotherapy was generally more effective than monotherapy among smokers, but one group of smokers, those who were low in nicotine dependence and who lived with a smoking spouse, did not show greater benefit from using combination pharmacotherapy. Use of monotherapy with these smokers might be justified considering the expense and side effects of combination pharmacotherapy.

SUBMITTER: Loh WY

PROVIDER: S-EPMC3265742 | biostudies-literature | 2012 Feb

REPOSITORIES: biostudies-literature

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Should all smokers use combination smoking cessation pharmacotherapy? Using novel analytic methods to detect differential treatment effects over 8 weeks of pharmacotherapy.

Loh Wei-Yin WY Piper Megan E ME Schlam Tanya R TR Fiore Michael C MC Smith Stevens S SS Jorenby Douglas E DE Cook Jessica W JW Bolt Daniel M DM Baker Timothy B TB

Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco 20111216 2

<h4>Introduction</h4>Combination pharmacotherapy for smoking cessation has been shown to be more effective than monotherapy in meta-analyses. We address the question of whether combination pharmacotherapy should be used routinely with smokers or if some types of smokers show little or no benefit from combination pharmacotherapy versus monotherapy.<h4>Methods</h4>Two smoking cessation trials were conducted using the same assessments and medications (bupropion, nicotine lozenge, nicotine patch, bu ...[more]

PMID: 22180577

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Project description:This study replicated and extended results of a previous trial, which found that combination varenicline/bupropion treatment increased smoking abstinence in smokers who were male, highly dependent, and who did not respond to prequit nicotine patch treatment with a >50% reduction in expired-air carbon monoxide in the first week.One hundred and twenty-two male nicotine patch nonresponders and 52 responders were identified. Smokers in each group were randomized to receive 12 weeks of varenicline plus bupropion treatment versus varenicline plus placebo. The primary outcome was continuous smoking abstinence at weeks 8-11 after the target quit date.For smokers with a high level of dependence, judged by having a baseline Fagerstrom Test for Nicotine Dependence (FTND) score ? 6 and cigarette consumption ? 20/d, combination varenicline/bupropion treatment increased the abstinence rate relative to varenicline alone: 71.0% versus 43.8% (odds ratio = 3.14; 95% confidence interval = 1.11-8.92, p [one tailed] = .016). In contrast, less dependent smokers did not show a benefit of combination treatment relative to varenicline (abstinence rates of 32.1% vs. 45.6%, respectively); there was a significant interaction of treatment and dependence level. Patch nonresponders tended to benefit the most from combination treatment, which was well tolerated overall.Combination varenicline/bupropion treatment proved significantly more efficacious than varenicline alone among highly dependent male smokers. These results, together with prior studies, support an adaptive treatment paradigm that assigns smoking cessation treatment according to baseline smoker characteristics and initial response to nicotine patch treatment.This study replicated, in a prospective manner, an important and surprising retrospective finding from a previous clinical trial, which showed that a specific subpopulation of smokers benefited substantially from receiving a combination treatment of varenicline plus bupropion, relative to varenicline plus placebo. Specifically, male smokers having high baseline nicotine dependence (FTND score ? 6 and cigarette consumption ? 20/d), showed a marked increase in smoking abstinence rate on combination pharmacotherapy. The present study likewise found an enhancement in end-of-treatment abstinence rate in this subgroup, from 43.8% to 71.0%. The adaptive treatment paradigm, which classifies smokers based on initial dependence level and response to prequit nicotine patch treatment, may be used to identify target populations of smokers whose success can be enhanced by intervening with combination pharmacotherapy before the quit-smoking date.ClinicalTrials.gov identifier: NCT01806779.

Project description:IntroductionNegative affect has been identified as a factor influencing continued smoking during pregnancy. In this study, a multi-component emotion regulation intervention was developed to address negative emotional smoking triggers and pilot-tested among low-income pregnant smokers. Treatment feasibility and acceptability, cotinine-verified rates of smoking cessation, and self-report of mean cigarettes smoked were assessed.MethodsPregnant smokers who self-reported smoking in response to negative affect (N = 70) were randomly assigned to receive one of two 8-session interventions: (1) emotion regulation treatment combined with standard cognitive-behavioral smoking cessation (ERT + CBT) or (2) a health and lifestyle plus standard smoking cessation active control (HLS + CBT). Outcomes for the 4-month period following the quit date are reported.ResultsTreatment attendance and subjective ratings provide evidence for the feasibility and acceptability of the ERT + CBT intervention. Compared with the HLS + CBT control condition, the ERT + CBT condition demonstrated higher abstinence rates at 2 months (ERT + CBT = 23% vs. HLS + CBT = 0%, OR = 13.51; 95% CI = 0.70-261.59) and 4 months (ERT = 18% vs. HLS = 5%; OR = 2.98; 95% CI = 0.39-22.72) post-quit. Mean number of cigarettes per day was significantly lower in ERT + CBT at 2 months (ERT + CBT = 2.73 (3.35) vs. HLS + CBT = 5.84 (6.24); p = .05) but not at 4 months (ERT + CBT = 2.15 (3.17) vs. HLS + CBT = 5.18 (2.88); p = .06) post-quit.ConclusionsThe development and initial test of the ERT + CBT intervention supports its feasibility and acceptability in this difficult-to-treat population. Further development and testing in a Stage II randomized clinical trial are warranted.ImplicationsNegative affect has been identified as a motivator for continued smoking during pregnancy. To date, smoking cessation interventions for pregnant smokers have not specifically addressed the role of negative affect as a smoking trigger. This treatment development pilot study provides support for the feasibility and acceptability of a multi-component ERT + CBT for low-income pregnant smokers who self-report smoking in response to negative affect. Study findings support further testing in a fully-powered Stage II efficacy trial powered to assess mediators and moderators of treatment effects.

Project description:Many lifelong smokers establish smoking habits during young adulthood. A university can be an effective setting for early smoking cessation. We evaluated long-term predictors of smoking cessation among smokers in a university setting.We longitudinally followed a cohort of smokers enrolled in a university smoking cessation program in Seoul, South Korea. Sociodemographic factors, smoking-related variables, and changes in smoking habits were assessed during 6-week visit sessions and follow-up telephone interviews conducted 1 year or more later.A total of 205 participants were followed up (mean follow-up duration: 27.1 months). Cessation rates were 47.3% at the end of the visit sessions and 28.8% at follow-up. The long-term persistent smoking rate was significantly higher among individuals with peers who smoked (odds ratio [OR] = 8.64; 95% confidence interval [CI] = 1.75, 42.80), with family members who smoked (OR = 3.28; 95% CI = 1.20, 9.00), and who smoked 10 to 19 cigarettes/day (OR?=?4.83; 95% CI?=?1.49, 15.69). Conversely, persistent smoking was less likely among those who attended the program regularly (OR?=?0.84 per visit; 95% CI?=?0.72, 0.99) and attempted quitting more frequently (OR?=?0.93 per attempt; 95% CI?=?0.87, 0.99). Use of smoking cessation medications (varenicline or bupropion) was not significantly associated with long-term quitting (OR?=?0.71; 95% CI?=?0.26, 1.93).Peer influences were the strongest predictors of failure in long-term cessation among smokers who attempted to quit. Similarly, the existence of smokers in the family was negatively associated with successful quitting. Regular attendance at a smoking cessation program and a high number of attempts to quit were positively associated with successful quitting. Targeting peer and family smoking groups together rather than targeting individual smokers alone, implementing active cessation programs encouraging regular attendance, and providing comprehensive antismoking environments might be effective strategies in a university setting.

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Should all smokers use combination smoking cessation pharmacotherapy? Using novel analytic methods to detect differential treatment effects over 8 weeks of pharmacotherapy.

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Should all smokers use combination smoking cessation pharmacotherapy? Using novel analytic methods to detect differential treatment effects over 8 weeks of pharmacotherapy.

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