ORIGINAL ARTICLE A Randomized Placebo-Controlled Clinical Trial of 5 Smoking Cessation Pharmacotherapies

Context: Little direct evidence exists on the relative ef-ficacies of different smoking cessation pharmacothera-pies, yet such evidence is needed to make informed de-cisions about their clinical use. Objective: To assess the relative efficacies of 5 smok-ing cessation pharmacotherapy interventions using pla-cebo-controlled, head-to-head comparisons. Design: A randomized, double-blind, placebo-controlled clinical trial. Setting: Two urban research sites. Patients: One thousand five hundred four adults who smoked at least 10 cigarettes per day during the past 6 months and reported being motivated to quit smoking. Participantswere excluded if they reported using any form of tobacco other than cigarettes; current use of bupro-pion; having a current psychosis or schizophrenia diag-nosis; or havingmedical contraindications for any of the study medications. Interventions: Participants were randomized to 1 of 6 treatment conditions: nicotine lozenge, nicotine patch, sustained-release bupropion, nicotine patch plus nico-tine lozenge, bupropion plus nicotine lozenge, or pla-cebo. In addition, all participants received 6 individual counseling sessions. Main Outcome Measures: Biochemically confirmed 7-day point-prevalence abstinence assessed at 1 week af-ter the quit date (postquit), end of treatment (8 weeks postquit), and 6 months postquit. Other outcomes were initial cessation, number of days to lapse, number of days to relapse, and latency to relapse after the first lapse. Results: All pharmacotherapies differed from placebo when examined without protection for multiple com-parisons (odds ratios, 1.63-2.34). With such protec-tion, only the nicotine patch plus nicotine lozenge (odds ratio, 2.34, P .001) produced significantly higher ab-stinence rates at 6-month postquit than did placebo. Conclusion:While the nicotine lozenge, bupropion, and bupropion plus lozenge produced effects that were com-parablewith those reported in previous research, the nico-tine patch plus lozenge produced the greatest benefit rela-tive to placebo for smoking cessation