A randomized placebo-controlled clinical trial of 5 smoking cessation pharmacotherapies

Abstract

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.

Figure 1. Study Time Line

Figure 1 illustrates the study timeline including all study visits for both assessment as well as treatment.

Figure 2. CONSORT and randomization information

Figure 2 is the CONSORT figure that documents the flow of participants from study recruitment, through screening, randomization and follow-up.

Figure 3. Latency to relapse (smoke on 3 consecutive days)

Figure 3 presents the survival curves for latency to relapse, or the number of days until the participants smoke on 7 consecutive days following the target quit day, for the 6 treatment conditions.