AIM: To test, in combination with the nicotine patch, the incremental efficacy of a maximal, tailored behavioral treatment over a minimal treatment for smoking cessation. DESIGN: Randomized clinical trial with 6-month follow-up. SETTING: Five methadone maintenance treatment centers in Rhode Island. PARTICIPANTS: Three hundred and eighty-three methadone-maintained smokers. INTERVENTION: Participants were assigned randomly to nicotine patch (8-12 weeks) plus either (1) a baseline tailored brief motivational intervention, a quit date behavioral skills counseling session and a relapse prevention follow-up session (Max) or (2) brief advice using the National Cancer Institute's 4 As model (Min). An intent-to-treat analysis with those lost to follow-up assumed to smoke was used. MEASUREMENTS: Carbon monoxide (CO)-confirmed 7-day point smoking cessation prevalence at 3 and 6 months, and self-reported numbers of cigarettes smoked per day. FINDINGS: Participants had a mean age of 40 years, were 53% male, 78% Caucasian, smoked 26.7 (+/- 12.2) cigarettes/day and had a mean methadone dose of 95.5 mg. At 3 months, 317 (83%) were re-interviewed; at 6 months, 312 (82%) were re-interviewed. The intent-to-treat, 7-day point prevalence estimate of cessation was 5.2% in the Max group and 4.7% in the Min group (P=0.81) at 6 months. In logistic models with treatment condition, age, gender, race, Fagerström Test for Nicotine Dependence and cigarettes per day as covariates, males were more likely to be abstinent at 3 months (OR 4.67; P=0.003) and 6 months (OR 4.01; P=0.015). CONCLUSION: A tailored behavioral intervention did not increase quit rates over patch and minimal treatment. Smoking cessation rates in methadone-maintained smokers are low, with men having greater success.
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