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A Randomized Trial

Gary E. Swan, PhD; Tim McAfee, MD, MPH; Susan J. Curry, PhD; Lisa M. Jack, MA; Harold Javitz, PhD; Sara Dacey, MD; Katherine Bergman, RPh

Arch Intern Med. 2003;163:2337-2344.

Background  The efficacy of bupropion hydrochloride sustained release (SR) (Zyban) for smoking cessation has been evaluated in clinical trials that included frequent in-person behavioral counseling, but not in actual practice settings.

Objective  To determine the differential effectiveness of 2 doses of bupropion SR in combination with behavioral interventions of minimal to moderate intensity in an actual practice setting.

Design  Open-label randomized trial, with 1 year of follow-up.

Setting  A large health system (Group Health Cooperative) based in Seattle.

Participants  Adult smokers (N = 1524) interested in quitting smoking.

Interventions  Participants were randomly assigned to receive 1 of 4 combinations of bupropion SR (150 or 300 mg) and behavioral counseling (minimal or moderate intensity).

Main Outcome Measures  The primary outcome measure was self-reported point-prevalence 7-day nonsmoking status at 3 and 12 months following the target quit date. Secondary outcomes included adverse and abstinence effects reported since beginning treatment with bupropion SR.

Results  At 3 months, a significantly higher rate of nonsmoking was observed among those receiving the larger bupropion SR dose (P=.005). At 12 months, moderate intensity counseling was associated significantly with a higher rate of nonsmoking (P=.001). At 3 months, the higher dose was associated with a significantly increased frequency of self-reported symptoms such as difficulty sleeping (P=.02), difficulty concentrating (P=.02), shakiness/tremor (P=.002), and gastrointestinal problems (P=.005)and a decreased frequency of reported desire to smoke (P=.001).

Conclusions  In this actual practice setting, the combination of bupropion SR and minimal or moderate counseling was associated with 1-year quit rates of 23.6% to 33.2%. This suggests that existing health care systems can substantially decrease tobacco use rates among their enrollees if they provide these modest interventions.

From the Center for Health Sciences, SRI International, Menlo Park, Calif (Drs Swan and Javitz and Ms Jack); and the Centers for Health Promotion (Drs McAfee and Dacey) and Health Studies (Dr Curry) and Pharmacy Administration (Ms Bergman), Group Health Cooperative, Seattle, Wash. Dr Curry is now with the School of Public Health, University of Illinois at Chicago. The authors have no relevant financial interest in this article, and received no financial support or medication from GlaxoSmithKline, which markets bupropion hydrochloride sustained release for smoking cessation under the trade name Zyban.

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