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This study aimed to evaluate the efficacy of varenicline directly observed therapy (DOT) on varenicline adherence and smoking cessation rates among smokers with opioid use disorder (OUD) receiving methadone treatment.<\/jats:p><\/jats:sec><jats:sec><jats:title>Design<\/jats:title><jats:p>Multicenter, parallel\u2010group two\u2010arm randomized controlled trial.<\/jats:p><\/jats:sec><jats:sec><jats:title>Setting<\/jats:title><jats:p>Urban opioid treatment program (OTP) in the Bronx, New York, USA.<\/jats:p><\/jats:sec><jats:sec><jats:title>Participants<\/jats:title><jats:p>Daily smokers of \u2265\u00a05 cigarettes\/day, interested in quitting (ladder of change score 6\u20138), in methadone treatment for \u2265\u00a03\u00a0months, attending OTP\u00a0\u2265\u00a03\u00a0days\/week. Participants\u2019 mean age was 49\u00a0years, 56% were male, 44% Latino, 30% Black, and they smoked a median of 10 cigarettes\/day.<\/jats:p><\/jats:sec><jats:sec><jats:title>Interventions<\/jats:title><jats:p>Individual, block, random assignment to 12\u00a0weeks of varenicline, either directly observed with methadone (DOT, <jats:italic>n<\/jats:italic>\u00a0=\u00a050) or via unsupervised self\u2010administered treatment (SAT, <jats:italic>n<\/jats:italic>\u00a0=\u00a050).<\/jats:p><\/jats:sec><jats:sec><jats:title>Measurements<\/jats:title><jats:p>The primary outcome was adherence measured by pill count. The secondary outcome was 7\u2010day point prevalence tobacco abstinence verified by expired carbon monoxide (CO)\u00a0&lt;\u00a08 parts per million.<\/jats:p><\/jats:sec><jats:sec><jats:title>Findings<\/jats:title><jats:p>Retention at 24\u00a0weeks was 92%. Mean adherence was 78.5% [95% confidence interval (CI)\u00a0=\u00a071.8\u201385.2%] in the DOT group versus 61.8% in the SAT group (95% CI\u00a0=\u00a055.0\u201368.6%); differences were driven by DOT effects in the first 6\u00a0weeks. CO\u2010verified abstinence did not differ between groups during the intervention (<jats:italic>P<\/jats:italic>\u00a0=\u00a00.26), but was higher in the DOT than the SAT group at intervention end (DOT\u00a0=\u00a018% versus SAT\u00a0=\u00a010%, difference\u00a0=\u00a08%, 95% CI\u00a0=\u00a0\u201313, 28); this difference was not significant (<jats:italic>P<\/jats:italic>\u00a0=\u00a00.39) and was not sustained at 24\u2010week follow\u2010up.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Among daily smokers attending opioid treatment programs, opioid treatment program\u2010based varenicline directly observed therapy was associated with early increases in varenicline adherence compared with self\u2010administered treatment, but findings were inconclusive as to whether directly observed therapy was associated with a difference in tobacco 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