A controlled trial of sustained-release bupropion, a nicotine patch, or both for smoking cessation

Background and Methods Use of nicotine-replacement therapies and the antide pressant bupropion helps people stop smoking. We conducted a double-blind, placebo-controlled comparison of sustained-release bupropion (244 subjects) , a nicotine patch (244 subjects), bupropion and a nicotine patch (245 subj ects), and placebo (160 subjects) for smoking cessation. Smokers with clini cal depression were excluded. Treatment consisted of nine weeks of bupropio n (150 mg a day for the first three days, and then 150 mg twice daily) or p lacebo, as well as eight weeks of nicotine-patch therapy (21 mg per day dur ing weeks 2 through 7,14 mg per day during week 8, and 7 mg per day during week 9) or placebo. The target day for quitting smoking was usually day 8. Results The abstinence rates at 12 months were 15.6 percent in the placebo group, as compared with 16.4 percent in the nicotine-patch group, 30.3 perc ent in the bupropion group (P<0.001), and 35.5 percent in the group given b upropion and the nicotine patch (P<0.001). By week 7, subjects in the place bo group had gained an average of 2.1 kg, as compared with a gain of 1.6 kg in the nicotine-patch group, a gain of 1.7 kg in the bupropion group, and a gain of 1.1 kg in the combined-treatment group (P<0.05). Weight gain at s even weeks was significantly less in the combined-treatment group than in t he bupropion group and the placebo group (P<0.05 for both comparisons). A t otal of 311 subjects (34.8 percent) discontinued one or both medications. S eventy-nine subjects stopped treatment because of adverse events: 6 in the placebo group (3.8 percent), 16 in the nicotine-patch group (6.6 percent), 29 in the bupropion group (11.9 percent), and 28 in the combined-treatment group (11.4 percent). The most common adverse events were insomnia and head ache. Conclusions Treatment with sustained-release bupropion alone or in combinat ion with a nicotine patch resulted in significantly higher long-term rates of smoking cessation than use of either the nicotine patch alone or placebo . Abstinence rates were higher with combination therapy than with bupropion alone, but the difference was not statistically significant. (N Engl J Med 1999;340:685-91.) (C) 1999, Massachusetts Medical Society.