A multicentre, randomized, double-blind, placebo-controlled, 1-year study of bupropion SR for smoking cessation

Abstract

Background. Bupropion sustained release (bupropion SR) has been shown to increase smoking cessation success rates in the US studies. Objective. To determine whether bupropion SR, in combination with counselling, is effective for smoking cessation in a multi-country study. Methods. This randomized, double-blind, placebo-controlled trial enrolled 707 smokers. A total of 527 received bupropion SR 300 mg daily for 7 weeks and 180 received placebo. A total of 11 clinic visits and 10 telephone contacts were scheduled, during the course of 1 year. Seven-week and 12-month abstinence rates were the study outcomes. Results. Both continuous and weekly point prevalence smoking abstinence rates were significantly higher in the bupropion SR group compared with placebo. The continuous abstinence rate from weeks 4 to 7 was 46% in the bupropion SR group compared with 23% in the placebo group [odds ratio (OR) = 2.82; 95% confidence interval (CI) 1.89-4.28; P < 0.001). At month 12, the continuous abstinence rates were 21% for the bupropion SR group and 11% for the placebo group (OR = 2.19; 95% CI 1.29-3.86, P = 0.002). For most nicotine-withdrawal symptoms small changes were measured. Adverse events were higher for the bupropion SR group compared with placebo (insomnia 24% vs. 15%; dry mouth 13% vs. 5%). Conclusion. Bupropion SR in combination with counselling increased the abstinence rate compared with placebo, and was well tolerated.