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Sustained-Release Bupropion for Pharmacologic Relapse Prevention after Smoking Cessation: A Randomized, Controlled Trial

J. Taylor Hays, MD; Richard D. Hurt, MD; Nancy A. Rigotti, MD; Raymond Niaura, PhD; David Gonzales, PhD; Michael J. Durcan, PhD; David P.L. Sachs, MD; Troy D. Wolter, MS; A. Sonia Buist, MD; J. Andrew Johnston, PhD; and Jonathan D. White, MS
[+] Article and Author Information

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.


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.


Ann Intern Med. 2001;135(6):423-433. doi:10.7326/0003-4819-135-6-200109180-00011
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Many effective behavioral and pharmacologic therapies are now available for treatment of smoking. The most effective strategy for treatment is combined behavioral intervention and pharmacologic therapy (1). Effective pharmacologic interventions for smoking cessation include several types of nicotine replacement and use of the non-nicotine medication bupropion (23). Despite treatment advances, smoking relapse after successful intervention for smoking cessation occurs in 70% to 80% of patients within 6 to 12 months (4).

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Figures

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Figure 1.
Flow of participants from screening through study completion.

SR = sustained release.

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Figure 2.
Observed cumulative smoking relapse, according to treatment group.solid linedotted linePP

The median time since randomization to smoking relapse was 65 days for the placebo group ( ) and 156 days for the bupropion group ( ) ( = 0.021, rank-sum test). Bupropion use had a significant effect compared with placebo at weeks 5 and 17 since randomization (study weeks 12 and 24, respectively). Compared with placebo, bupropion use had no significant effect on preventing smoking relapse across time for the entire study duration after randomization ( = 0.100 by proportional hazards regression).

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Figure 3.
Mean change in weight from baseline.Ptsolid linedotted lineP

The mean change in weight from baseline was significantly greater than zero ( < 0.001 by the one-sample -test) at week 3 and at each subsequent visit for both the placebo ( ) and bupropion ( ) groups. The mean weight changes significantly differed between the placebo and bupropion groups ( < 0.05 with adjustment for baseline weight and week-7 weight change from baseline) at each visit after randomization except at weeks 10, 12, and 24. Data were available for 215, 213, 156, and 152 participants in the placebo group and 214, 213, 162, and 150 participants in the bupropion group at baseline and weeks 7, 52, and 104, respectively. During the first 7 weeks of treatment, both groups received active bupropion.

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Summary for Patients

Bupropion To Prevent Relapse in People Who Quit Cigarette Smoking

The summary below is from the full report titled “Sustained-Release Bupropion for Pharmacologic Relapse Prevention after Smoking Cessation. A Randomized, Controlled Trial.” It is in the 18 September 2001 issue of Annals of Internal Medicine (volume 135, pages 423-433). The authors are JT Hays, RD Hurt, NA Rigotti, R Niaura, D Gonzales, MJ Durcan, DPL Sachs, TD Wolter, AS Buist, JA Johnston, and JD White.

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