Incremental efficacy of adding bupropion to the nicotine patch for smoking cessation in smokers with a recent history of alcohol dependence: results from a randomized, double-blind, placebo-controlled study.

AIMS: The primary aim of this study was to compare the efficacy of smoking cessation treatment using a combination of nicotine patch and bupropion vs. nicotine patch and placebo bupropion. A secondary aim was to investigate whether the efficacy of bupropion is moderated by belief about whether one is receiving active or placebo medication.

METHODS: Participants were recruited from a residential substance abuse treatment program and the community. We randomly assigned 148 smokers with between 2 and 12 months of alcohol abstinence to nicotine patch plus bupropion or nicotine patch plus placebo. All participants also received seven counseling sessions.

RESULTS: At follow up, differences between medication conditions were not significant. Seven-day point prevalence quit rates in the patch plus bupropion vs. patch plus placebo conditions at week 24 were 6% and 11%, respectively. Differences between groups on prolonged abstinence and time to first smoking lapse were also not significant. However, among participants who received bupropion, those who accurately "guessed" that they were receiving bupropion were more likely to remain abstinent than those who incorrectly believed they were receiving placebo.

CONCLUSIONS: Findings do not support combining nicotine patch and bupropion for smoking cessation in this population. However, findings support previous studies suggesting the importance of assessing the blind in smoking cessation studies and its possible moderating effect on medication efficacy. Future directions for enhancing smoking cessation outcome in these smokers include investigations of intensive behavioral and pharmacological interventions, including studies of potential interactions between individual genetic differences and medication efficacy.