A Controlled Trial of Sustained-Release Bupropion, a Nicotine Patch, or Both for Smoking Cessation
Douglas E. Jorenby, Ph.D., Scott J. Leischow, Ph.D., Mitchell A. Nides, Ph.D., Stephen I. Rennard, M.D., J. Andrew Johnston, Pharm.D., Arlene R. Hughes, Ph.D., Stevens S. Smith, Ph.D., Myra L. Muramoto, M.D., David M. Daughton, M.S., Kimberli Doan, B.S., Michael C. Fiore, M.D., M.P.H., and Timothy B. Baker, Ph.D.
Background and Methods Use of nicotine-replacement therapiesand the antidepressant bupropion helps people stop smoking.We conducted a double-blind, placebo-controlled comparison ofsustained-release bupropion (244 subjects), a nicotine patch(244 subjects), bupropion and a nicotine patch (245 subjects),and placebo (160 subjects) for smoking cessation. Smokers withclinical depression were excluded. Treatment consisted of nineweeks of bupropion (150 mg a day for the first three days, andthen 150 mg twice daily) or placebo, as well as eight weeksof nicotine-patch therapy (21 mg per day during weeks 2 through7, 14 mg per day during week 8, and 7 mg per day during week9) or placebo. The target day for quitting smoking was usuallyday 8.
Results The abstinence rates at 12 months were 15.6 percentin the placebo group, as compared with 16.4 percent in the nicotine-patchgroup, 30.3 percent in the bupropion group (P<0.001), and35.5 percent in the group given bupropion and the nicotine patch(P<0.001). By week 7, subjects in the placebo group had gainedan average of 2.1 kg, as compared with a gain of 1.6 kg in thenicotine-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 seven weeks was significantly less in the combined-treatmentgroup than in the bupropion group and the placebo group (P<0.05for both comparisons). A total of 311 subjects (34.8 percent)discontinued one or both medications. Seventy-nine subjectsstopped treatment because of adverse events: 6 in the placebogroup (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-treatmentgroup (11.4 percent). The most common adverse events were insomniaand headache.
Conclusions Treatment with sustained-release bupropion aloneor in combination with a nicotine patch resulted in significantlyhigher long-term rates of smoking cessation than use of eitherthe nicotine patch alone or placebo. Abstinence rates were higherwith combination therapy than with bupropion alone, but thedifference was not statistically significant.
Source Information
From the Center for Tobacco Research and Intervention, University of Wisconsin Medical School, Madison (D.E.J., S.S.S., M.C.F., T.B.B.); the Arizona Program for Nicotine and Tobacco Research, University of Arizona, Tucson (S.J.L., M.L.M.); Los Angeles Clinical Trials, Los Angeles (M.A.N., K.D.); the Pulmonary and Critical Care Medicine Section, University of Nebraska Medical Center, Omaha (S.I.R., D.M.D.); and Glaxo Wellcome, Research Triangle Park, N.C. (J.A.J., A.R.H.).
Address reprint requests to Dr. Jorenby at 1300 University Ave., Rm. 7278 MSC, Madison, WI 53706.
Smoking Cessation
Hughes J. R., Jorenby D. E., Fiore M. C., Baker T. B.
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N Engl J Med 1999;
341:610-611, Aug 19, 1999.
Correspondence
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A correction has been published: N Engl J Med 1999;341(8):610.
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