A double-blind, placebo-controlled, randomized trial of bupropion for smoking cessation in primary care

Background: Studies undertaken in academic settings have shown that bupropion hydrochloride can double the odds of smoking cessation compared with placebo. To assess whether these results are applicable in primary care, we launched a double-blind, placebo-controlled, randomized trial to be conducted by general practitioners. Methods: We assigned 593 healthy smokers to receive bupropion hydrochloride, 150 mg twice a day, or placebo daily for 7 weeks (hereinafter, bupropion group [n=400] and placebo group [n=193], respectively). After the baseline visit, 4 clinical visits and 3 telephone calls were scheduled over the 1-year period. The primary end points were biochemically confirmed continuous abstinence at week 7 and at week 52. Results: Seventy-one Italian general practitioners enrolled participants from April 2004 to May 2005. Of the bupropion group, 41.0% were continuously abstinent from week 4 to week 7 compared with 22.3% of the placebo group (multivariate odds ratio, 2.37; 95% confidence interval, 1.60-3.53). The continuous abstinence rates from week 4 to week 52 were 25% in the bupropion group and 14% in the placebo group (odds ratio, 2.11; 95% confidence interval, 1.32-3.39). The mean weight gain was similar in both groups and among long-term abstainers was 3 kg in women and 4 kg in men. More participants in the bupropion group experienced an adverse event than those in the placebo group, but the percentage who discontinued use of the study medication was similar. Conclusions: Bupropion more than doubled the odds of continuous abstinence from smoking. The adherence of general practitioners and participants to the protocol was excellent, making our findings robust and easy to generalize to the context of primary care.