A placebo-controlled trial of bupropion combined with nicotine patch for smoking cessation in schizophrenia

Abstract

Background: Individuals with schizophrenia smoke at higher rates (58%-88%) than the general population (approximately 22%), and have difficulty quitting. We determined whether the combination of sustained-release (SR) bupropion (BUP) with the transdermal nicotine patch (TNP) was well-tolerated and superior to placebo (PLO)+TNP for smoking cessation in schizophrenia.

Methods: A 10-week, double-blind, placebo-controlled trial of BUP (300 mg/day) in combination with TNP (21 mg/24h) for 58 outpatient smokers with schizophrenia was conducted. Primary outcome measures were continuous smoking abstinence in the last 4 weeks of the trial (Days 43-70) and 7-day point prevalence abstinence at 6 months post-target quit date (TQD) (week 26).

Results: Smokers assigned to the BUP+TNP group (n = 29) were more likely to achieve continuous smoking abstinence (8/29, 27.6%) than the PLO+TNP group (n = 29, 1/29, 3.4%) [Fisher's Exact Test, p < .05]; at 6-months post-TQD, 4/29 (13.8%) versus 0/29 (0.0%) achieved 7-day point prevalence smoking abstinence (p = .11). Neither bupropion SR nor smoking abstinence significantly altered the positive or negative symptoms of schizophrenia. The combination was well-tolerated in smokers with schizophrenia.

Conclusions: Combination therapy with bupropion SR+TNP versus placebo+TNP is well-tolerated and significantly improved short-term smoking abstinence in smokers with schizophrenia.

Trial registration: ClinicalTrials.gov NCT00124683.

Figures

Figure 1

Smoking Abstinence Rates in Bupropion SR and Placebo Groups during the 10-week Trial and at the Six Month Assessment. Abbreviations: BUP, Bupropion; PLO, placebo; TNP, transdermal nicotine patch; EOT, End of Trial; CA, Continuous Abstinence; 6MFU, Six Month Follow-up (Week 26) * Fisher’s Exact 2-Sided Test for EOT, p=0.056; CA, p