Effectiveness of Bupropion Sustained Release for Smoking Cessation in a Health Care Setting: A Randomized Trial

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.

[1]  G. Swan,et al.  Bupropion SR and smoking cessation in actual practice: methods for recruitment, screening, and exclusion for a field trial in a managed-care setting. , 2003, Preventive medicine.

[2]  W. Velicer,et al.  Biochemical verification of tobacco use and cessation. , 2002, Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco.

[3]  L. Solberg,et al.  Aids to quitting tobacco use: how important are they outside controlled trials? , 2001, Preventive medicine.

[4]  B. Jamerson,et al.  Bupropion SR as an aid to smoking cessation in smokers treated previously with bupropion: A randomized placebo‐controlled study , 2001, Clinical pharmacology and therapeutics.

[5]  P. Anderson,et al.  Smoking cessation in patients with chronic obstructive pulmonary disease: a double-blind, placebo-controlled, randomised trial , 2001, The Lancet.

[6]  B. Jamerson,et al.  Late-term smoking cessation despite initial failure: an evaluation of bupropion sustained release, nicotine patch, combination therapy, and placebo. , 2001, Clinical therapeutics.

[7]  M. Sevick,et al.  Measuring adherence to behavioral and medical interventions. , 2000, Controlled clinical trials.

[8]  Michael C. Fiore,et al.  A Clinical Practice Guideline for Treating Tobacco Use and Dependence A US Public Health Service Report , 2000 .

[9]  K. Harris,et al.  Pharmacotherapy of smoking cessation. , 2000, Archives of family medicine.

[10]  K. Farmer,et al.  Methods for measuring and monitoring medication regimen adherence in clinical trials and clinical practice. , 1999, Clinical therapeutics.

[11]  Aker,et al.  A controlled trial of sustained-release bupropion, a nicotine patch, or both for smoking cessation. , 1999, The New England journal of medicine.

[12]  S. Shiffman,et al.  Recent advances in the pharmacotherapy of smoking. , 1999, JAMA.

[13]  M. Hindmarsh,et al.  The role of tobacco intervention in population-based health care: a case study. , 1998, American journal of preventive medicine.

[14]  M. Goldstein.  Bupropion sustained release and smoking cessation. , 1998, The Journal of clinical psychiatry.

[15]  Darrell R. Schroeder,et al.  A Comparison of Sustained-Release Bupropion and Placebo for Smoking Cessation , 1997 .

[16]  R. Moore,et al.  Using Numerical Results from Systematic Reviews in Clinical Practice , 1997, Annals of Internal Medicine.

[17]  E. Wagner,et al.  Cost-effectiveness comparisons using "real world" randomized trials: the case of new antidepressant drugs. , 1995, Journal of clinical epidemiology.

[18]  Diane C. Thompson,et al.  The validity of self-reported smoking: a review and meta-analysis. , 1994, American journal of public health.

[19]  J. Hollis,et al.  Biochemical validation of smoking status: pros, cons, and data from four low-intensity intervention trials. , 1993, Addictive behaviors.

[20]  W F Velicer,et al.  Assessing outcome in smoking cessation studies. , 1992, Psychological bulletin.

[21]  L. Kozlowski,et al.  The Fagerström Test for Nicotine Dependence: a revision of the Fagerström Tolerance Questionnaire. , 1991, British journal of addiction.

[22]  E H Wagner,et al.  Self-help quit smoking interventions: effects of self-help materials, social support instructions, and telephone counseling. , 1991, Journal of consulting and clinical psychology.

[23]  L. Covi,et al.  The Hopkins Symptom Checklist (HSCL): a self-report symptom inventory. , 1974, Behavioral science.