Treating nondepressed smokers with alcohol dependence in sustained full remission: Nicotine patch therapy tailored to baseline serum cotinine

Objective: Studies of the efficacy of nicotine replacement therapy among alcoholic smokers have produced mixed findings. Our objective was to examine the smoking abstinence rate in smokers in sustained full remission from alcoholism (as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) who are receiving nicotine patch therapy with the dose tailored to the baseline serum cotinine concentration. Method: In this pharmacological relapse prevention study for 195 smokers with alcohol dependence in sustained full remission, the primary aim was to determine the 7-day point prevalence smoking abstinence rate at the end of 8 weeks of nicotine patch therapy in doses projected to achieve 100% venous replacement. Nicotine patch dose was based on the baseline serum venous cotinine as follows: (1) participants with ≤200 ng/ml received a patch dose of 22 mg per day; (2) those with 201-300 ng/ml received a 33-mg dose per day, and (3) those with >300 ng/ml received a 44-mg dose per day, A second (steady-state) serum cotinine concentration was obtained between weeks 2 and 7 to determine the percentage replacement. Results: The point prevalence smoking abstinence rate at the end of the 8 weeks of nicotine patch treatment was 51% (95% confidence interval [CI]: 45%-58%) which is higher than would be expected, and percent replacement of >80% was achieved in 49 of 85 (58%) tobacco-abstinent subjects. Higher cigarettes per day (odds ratio [OR] = 1.030, 95% CI: 1.004-1.057, p = .023) and a history of depressed mood on the Diagnostic Interview Schedule (OR = 1.940, 95% CI: 1.044-3.605, p = .036) were found to be multivariate independent predictors of smoking at week 8. However, percentage replacement did not predict smoking abstinence. Conclusion: We achieved >80% replacement in most subjects, and there was no evidence of severe nicotine toxicity associated with the tailored dose of nicotine patch therapy.