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Background Randomized efficacy clinical trials conducted in research settings may not accurately reflect the benefits of tobacco dependence treatments when used in real-world clinical settings. Effectiveness trials (e.g., in primary care settings) are needed to estimate the benefits of cessation treatments in real-world use. Methods 1346 primary care patients attending routine appointments were recruited by medical assistants in 12 primary care clinics. Patients were randomly assigned to five active pharmacotherapies: three monotherapies (Nicotine Patch, Nicotine Lozenge, and Bupropion SR) and two combination therapies (Patch+Lozenge and Bupropion+Lozenge). Patients were referred to a telephone quitline for cessation counseling. Primary outcomes included seven-day point-prevalence abstinence at one week, eight weeks, and six months post-quit, and number of days to relapse. Results Among 7128 eligible smokers (≥ 10 cigarettes per day) attending routine primary care appointments, 19% (N=1346) enrolled in the study. Six month abstinence rates were: Bupropion=16.8%; Lozenge=19.9%; Patch=17.7%; Patch+Lozenge=26.9%; and Bupropion+Lozenge=29.9%. Bupropion SR+Lozenge was superior to all of the monotherapies (odds ratios [ORs]: 0.46 to 0.56); Patch+Lozenge was superior to Patch and Bupropion monotherapies (ORs: 0.56 and 0.54, respectively). Conclusions One in five smokers attending a routine primary care appointment was willing to make a serious quit attempt that included evidence-based counseling and medication. In this comparative effectiveness study of five tobacco dependence treatments, combination pharmacotherapy significantly increased abstinence compared to monotherapies. Provision of free cessation medications plus quitline counseling arranged in the primary care setting holds promise for assisting large numbers of smokers to quit.

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