A Comparison of Sustained-Release Bupropion and Placebo for Smoking Cessation
Richard D. Hurt, M.D., David P.L. Sachs, M.D., Elbert D. Glover, Ph.D., Kenneth P. Offord, M.S., J. Andrew Johnston, Pharm.D., Lowell C. Dale, M.D., Moise A. Khayrallah, Ph.D., Darrell R. Schroeder, M.S., Penny N. Glover, M.Ed., C. Rollynn Sullivan, M.D., Ivana T. Croghan, Ph.D., and Pamela M. Sullivan, M.D.
Background and Methods Trials of antidepressant medicationsfor smoking cessation have had mixed results. We conducted adouble-blind, placebo-controlled trial of a sustained-releaseform of bupropion for smoking cessation. We excluded smokerswith current depression, but not those with a history of majordepression. The 615 subjects were randomly assigned to receiveplacebo or bupropion at a dose of 100, 150, or 300 mg per dayfor seven weeks. The target quitting date (or "target quit date")was one week after the beginning of treatment. Brief counselingwas provided at base line, weekly during treatment, and at 8,12, 26, and 52 weeks. Self-reported abstinence was confirmedby a carbon monoxide concentration in expired air of 10 ppmor less.
Results At the end of seven weeks of treatment, the rates ofsmoking cessation as confirmed by carbon monoxide measurementswere 19.0 percent in the placebo group, 28.8 percent in the100-mg group, 38.6 percent in the 150-mg group, and 44.2 percentin the 300-mg group (P<0.001). At one year the respectiverates were 12.4 percent, 19.6 percent, 22.9 percent, and 23.1percent. The rates for the 150-mg group (P = 0.02) and the 300-mggroup (P = 0.01) but not the 100-mg group (P = 0.09) were significantly better than those for the placebogroup. Among the subjects who were continuously abstinent throughthe end of treatment, the mean absolute weight gain was inverselyassociated with the dose (a gain of 2.9 kg in the placebo group,2.3 kg in 100-mg and 150-mg groups, and 1.5 kg in the 300-mggroup; P = 0.02). No effects of treatment were observed on depressionscores as measured serially by the Beck Depression Inventory.Thirty-seven subjects stopped treatment prematurely becauseof adverse events; the frequency was similar among all groups.
Conclusions A sustained-release form of bupropion was effectivefor smoking cessation and was accompanied by reduced weightgain and minimal side effects. Many participants in all groupswere smoking at one year.
Source Information
From the Nicotine Research Center (R.D.H., L.C.D., I.T.C.), the Section of Biostatistics (K.P.O., D.R.S.), and the Division of Community Internal Medicine (R.D.H., L.C.D.), Mayo Clinic and Mayo Foundation, Rochester, Minn.; the Palo Alto Center for Pulmonary Disease Prevention, Palo Alto, Calif. (D.P.L.S.); Robert C. Byrd Health Sciences Center, West Virginia University, Morgantown (E.D.G., P.N.G., C.R.S., P.M.S.); and Glaxo Wellcome, Inc., Research Triangle Park, N.C. (J.A.J., M.A.K.).
Address reprint requests to Dr. Hurt at the Mayo Clinic, 200 First St. SW, Rochester, MN 55905.
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