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ContextThe majority of cigarette smokers who achieve abstinence relapse within the first year and require many attempts before achieving permanent abstinence. Evidence to support pharmacological treatment for relapse prevention is insufficient.ObjectiveTo determine whether smokers who quit after 12 weeks of treatment with varenicline, a selective α4β2 nicotinic acetylcholine receptor partial agonist, maintain greater continuous abstinence rates (defined as not a single “puff” of a cigarette) than placebo controls during an additional 12 weeks of treatment and until 52 weeks after treatment initiation.Design, Setting, and ParticipantsRandomized controlled trial conducted at multiple medical clinics in 7 countries with follow-up to 52 weeks after study baseline. Of 1927 cigarette smokers recruited between April 2003 and February 2004 and treated for 12 weeks with open-label varenicline titrated to 1 mg twice per day …