A Randomized Placebo-Controlled Clinical Trial of 5 Smoking Cessation Pharmacotherapies | Clinical Pharmacy and Pharmacology | JAMA Psychiatry | JAMA Network
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Original Article
November 2009

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

Author Affiliations

Author Affiliations: Center for Tobacco Research and Intervention (Drs Piper, Smith, Schlam, Fiore, Jorenby, and Baker and Mr Fraser), and Department of Medicine (Drs Smith, Fiore, Jorenby, and Baker), University of Wisconsin School of Medicine and Public Health, Madison.

Arch Gen Psychiatry. 2009;66(11):1253-1262. doi:10.1001/archgenpsychiatry.2009.142

Context  Little direct evidence exists on the relative efficacies of different smoking cessation pharmacotherapies, yet such evidence is needed to make informed decisions about their clinical use.

Objective  To assess the relative efficacies of 5 smoking cessation pharmacotherapy interventions using placebo-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. Participants were excluded if they reported using any form of tobacco other than cigarettes; current use of bupropion; having a current psychosis or schizophrenia diagnosis; or having medical 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 nicotine lozenge, bupropion plus nicotine lozenge, or placebo. In addition, all participants received 6 individual counseling sessions.

Main Outcome Measures  Biochemically confirmed 7-day point-prevalence abstinence assessed at 1 week after 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 comparisons (odds ratios, 1.63-2.34). With such protection, only the nicotine patch plus nicotine lozenge (odds ratio, 2.34, P < .001) produced significantly higher abstinence rates at 6-month postquit than did placebo.

Conclusion  While the nicotine lozenge, bupropion, and bupropion plus lozenge produced effects that were comparable with those reported in previous research, the nicotine patch plus lozenge produced the greatest benefit relative to placebo for smoking cessation.