Effects of topiramate or naltrexone on tobacco use among male alcohol-dependent outpatients.

Author(s): Baltieri DA, Daro FR, Ribeiro PL, Andrade AG

Affiliation(s): Department of Psychiatry of the University of Sao Paulo, Brazil. dbaltieri@uol.com.br

Publication date & source: 2009-11-01, Drug Alcohol Depend., 105(1-2):33-41.

Publication type: Randomized Controlled Trial; Research Support, Non-U.S. Gov't

BACKGROUND: A high smoking prevalence has been registered among alcoholics. It has been pointed out that alcoholic smokers may have a more severe course and greater severity of alcoholism. This study aims at comparing smoking and non-smoking alcoholics in terms of treatment outcomes and verifying the efficacy of topiramate and naltrexone to decrease the use of cigarettes among alcoholic smokers. METHODS: The investigation was a double-blind, placebo-controlled, 12-week study carried out at the University of Sao Paulo, Brazil. The sample comprised 155 male alcohol-dependent outpatients (52 non-smokers and 103 smokers), 18-60 years of age, with an International Classification of Diseases (ICD-10) diagnosis of alcohol dependence. After a 1-week detoxification period, the patients randomly received placebo, naltrexone (50mg/day) or topiramate (up to 300 mg/day). Only the alcoholic smokers who adhered to the treatment were evaluated with reference to the smoking reduction. RESULTS: Cox regression analysis revealed that the smoking status among alcoholics increased the odds of relapse into drinking by 65%, independently of the medications prescribed, using the intention-to-treat method. Topiramate showed effectiveness to reduce the number of cigarettes smoked when compared to placebo among adherent patients (mean difference=7.91, p<0.01). There were no significant differences between the naltrexone group and the placebo group. CONCLUSIONS: The results of this study confirm that the treatment is more challenging for smoking alcoholics than for non-smoking ones and support the efficacy of topiramate in the smoking reduction among male alcoholic smokers who adhered to the treatment.