Sustained-Release Bupropion for Pharmacologic Relapse Prevention after Smoking Cessation

Sustained-Release Bupropion for Pharmacologic Relapse Prevention after Smoking Cessation

A Randomized, Controlled Trial

From the Mayo Clinic and Mayo Foundation, Rochester, Minnesota; Massachusetts General Hospital, Boston, Massachusetts; Brown University, Providence, Rhode Island; Oregon Health Science University, Portland, Oregon; Glaxo Wellcome, Inc., Research Triangle Park, North Carolina; Palo Alto Center for Pulmonary Disease Prevention, Palo Alto, California; and Stanford University School of Medicine, Stanford, California.

Abstract

Background: Smoking relapse is common after successful pharmacologic treatment 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 smoking and who smoked at least 15 cigarettes per day.

Intervention: The participants received open-label, sustained-release bupropion, 300 mg/d, for 7 weeks. Participants who were abstinent throughout week 7 of open-label treatment were randomly assigned to receive bupropion, 300 mg/d, or placebo for 45 weeks and were subsequently followed for an additional year after the conclusion of the medication phase. Participants were briefly counseled at all follow-up visits. At the end of open-label bupropion treatment, 461 of 784 participants (58.8%) were abstinent from smoking.

Measurement: Self-reported abstinence was confirmed by an expired air carbon monoxide concentration of 10 parts per million or less.

Results: The point prevalence of smoking abstinence was significantly higher 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 greater for bupropion recipients than for placebo recipients (156 days vs. 65 days; P = 0.021). The continuous abstinence rate was higher in the bupropion group than in the placebo group at study week 24 (17 weeks after randomization) (52.3% vs. 42.3%; P = 0.037) but did not differ between groups after week 24. Weight gain was significantly less in the bupropion group than in the placebo group at study weeks 52 (3.8 kg vs. 5.6 kg; P = 0.002) and 104 (4.1 kg vs. 5.4 kg; P = 0.016).

Conclusions: In persons who stopped smoking with 7 weeks of bupropion treatment, sustained-release bupropion for 12 months delayed smoking relapse and resulted in less weight gain.

Article and Author Information

Acknowledgments: The authors thank Sue Wondrasch, Rhonda Baumberger, and JulieLynn Eckel for manuscript preparation.
Grant Support: By Glaxo Wellcome, Inc., Research Triangle Park, North Carolina.
Requests for Single Reprints: J. Taylor Hays, MD, Nicotine Research Center, Mayo Clinic, 200 First Street SW, Rochester, MN 55905.
Current Author Addresses: Drs. Hays and Hurt: Nicotine Dependence Center, Mayo Clinic, 200 First Street SW, Rochester, MN 55905.
Dr. Rigotti: General Internal Medicine, Massachusetts General Hospital, 50 Staniford Street, 9th Floor, Boston, MA 02114.
Dr. Niaura: Center for Behavioral and Preventive Medicine, The Miriam Hospital, 164 Summit Avenue, Providence, RI 02906.
Dr. Gonzales: Smoking Cessation Center, Oregon Health Sciences University, 3181 SW Sam Jackson Park Road, CR 115, Portland, OR 97201.
Drs. Durcan and Johnston and Mr. White: Glaxo Wellcome, Inc., 5 Moore Drive, Research Triangle Park, NC 27709.
Dr. Sachs: Palo Alto Center for Pulmonary Disease Prevention, 145 North California Avenue, Palo Alto, CA 94301-3911.
Dr. Wolter: Section of Biostatistics, Mayo Clinic, 200 First Street SW, Rochester, MN 55905.
Dr. Buist: Division of Pulmonary and Critical Care, Oregon Health Sciences University, 3181 SW Sam Jackson Park Road, Portland, OR 97201.
Author Contributions: Conception and design: R.D. Hurt, R. Niaura, D. Gonzales, M.J. Durcan, D.P.L. Sachs, J.A. Johnston.
Analysis and interpretation of the data: J.T. Hays, R.D. Hurt, N.A. Rigotti, R. Niaura, D. Gonzales, M.J. Durcan, D.P.L. Sachs, T.D. Wolter, A.S. Buist, J.A. Johnston, J.D. White.
Drafting of the article: J.T. Hays, R.D. Hurt, N. Rigotti, R. Niaura, D. Gonzales, M.J. Durcan, D.P.L. Sachs, T.D. Wolter, A.S. Buist, J.A. Johnston, and J.D. White.
Critical revision of the article for important intellectual content: J.T. Hays, R.D. Hurt, N.A. Rigotti, R. Niaura, D. Gonzales, M.J. Durcan, D.P.L. Sachs, T.D. Wolter, J.A. Johnston, J.D. White.
Final approval of the article: J.T. Hays, R.D. Hurt, N.A. Rigotti, R. Niaura, D. Gonzales, M.J. Durcan, T.D. Wolter, A.S. Buist, J.A. Johnston, J.D. White.
Provision of study materials or patients: J.T. Hays, N.A. Rigotti, R. Niaura, D. Gonzales, A.S. Buist, J.A. Johnston.
Statistical expertise: M.J. Durcan, T.D. Wolter, J.D. White.
Obtaining of funding: R.D. Hurt, M.J. Durcan, J.A. Johnston.
Administrative, technical, or logistic support: J.T. Hays, R.D. Hurt, D. Gonzales, M.J. Durcan, J.A. Johnston, J.D. White.
Collection and assembly of data: J.T. Hays, R.D. Hurt, N.A. Rigotti, R. Niaura, D. Gonzales, M.J. Durcan, D.P.L. Sachs, T.D. Wolter, A.S. Buist, J.A. Johnston, J.D. White.