Sustained-release bupropion for pharmacologic relapse prevention after smoking cessation - A randomized, controlled trial

Background: Smoking relapse is common after successful pharmacologic treatm ent for smoking cessation. No previous studies have examined long-term drug therapy used expressly for prevention of smoking relapse. Objective: To evaluate the efficacy of bupropion to prevent smoking relapse . Design: Randomized, placebo-controlled trial. Participants: 784 healthy community volunteers who were motivated to quit s moking and who smoked at least 15 cigarettes per day. Intervention: The participants received open-label, sustained-release bupro pion, 300 mg/d, for 7 weeks. Participants who were abstinent throughout wee k 7 of open-label treatment were randomly assigned to receive bupropion, 30 0 mg/d, or placebo for 45 weeks and were subsequently followed for an addit ional year after the conclusion of the medication phase. Participants were briefly counseled at all follow-up visits. At the end of open-label bupropi on treatment, 461 of 784 participants (58.8%) were abstinent from smoking. Measurement: Self-reported abstinence was confirmed by an expired air carbo n monoxide concentration of 10 parts per million or less. Results: The point prevalence of smoking abstinence was significantly highe r in the bupropion group than in the placebo group at the end (week 52) of drug therapy (55.1% vs. 42.3%, respectively; P = 0.008) and at week 78 (47. 7% vs. 37.7%; P = 0.034) but did not differ at the final (week 104) follow- up visit (41.6% vs. 40.0%). The median time to relapse was significantly gr eater for bupropion recipients than for placebo recipients (156 days vs. 65 days; P = 0.021). The continuous abstinence rate was higher in the bupropi on group than in the placebo group at study week 24 (17 weeks after randomi zation) (52.3% vs. 42.3%; P = 0.037) but did not differ between groups afte r week 24. Weight gain was significantly less in the bupropion group than i n the placebo group at study weeks 52 (3.8 kg vs. 5.6 kg; P = 0.002) and 10 4 (4.1 kg vs. 5.4 kg; P = 0.016). Conclusions: in persons who stopped smoking with 7 weeks of bupropion treat ment, sustained-release bupropion for 12 months delayed smoking relapse and resulted in less weight gain.