Nicotine replacement therapy for smoking cessation has become a popular mode of treatment with the advent of nicotine gum and, more recently, transdermal nicotine (patch). Largely because of ease of compliance and an improved adverse-effect profile, transdermal nicotine has become the preferred method for pharmacological therapy. Whereas numerous clinical trials have demonstrated the efficacy of the patch relative to a placebo, the level of intensity of adjuvant counseling to achieve an acceptable rate of cessation remains uncertain. The investigators propose a study involving 1,900 smokers to be recruited to a randomized five-group design involving different combinations of transdermal nicotine plus usual care, telephone based counseling, or group-based counseling. Study participants will be followed for 13 months to determine a treatment outcome. Because treatment efficiency cannot be completely addressed without consideration of patient-treatment interactions and adequate valuations of the different treatment alternatives, the investigators also propose to use analytic methods from clinical medicine and pharmacoeconomics (cost-effectiveness analysis) to focus on these aspects of the overall research question. This study will be conducted in collaboration with the nation's largest health maintenance organization, Kaiser Permanente Medical Care Plan (KPMCP) of Northern California.
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