Comparing topiramate with naltrexone in the treatment of alcohol dependence.

AIM To compare the efficacy of topiramate with naltrexone in the treatment of alcohol dependence. DESIGN The investigation was a double-blind, placebo-controlled, 12-week study carried out at the University of São Paulo, Brazil. SAMPLE A total of 155 patients, 18-60 years of age, with an International Classification of Diseases (ICD-10) diagnosis of alcohol dependence. METHODS After a 1-week detoxification period, patients were assigned randomly to receive topiramate (induction to 300 mg/day), naltrexone (50 mg/day) or placebo. MEASUREMENTS Time to first relapse (consumption of >60 g ethyl alcohol), cumulative abstinence duration and weeks of heavy drinking. FINDINGS In intention-to-treat analyses, topiramate was statistically superior to placebo on a number of measures including time to first relapse (7.8 versus 5.0 weeks), cumulative abstinence duration (8.2 versus 5.6 weeks), weeks of heavy drinking (3.4 versus 5.9) and percentage of subjects abstinent at 4 weeks (67.3 versus 42.6) and 8 weeks (61.5 versus 31.5), but not 12 weeks (46.2 versus 27.8). RESULTS remained significant after controlling for Alcoholics Anonymous attendance, which was higher in topiramate than in other groups. There were no significant differences between naltrexone versus placebo or naltrexone versus topiramate groups, but naltrexone showed trends toward inferior outcomes when compared to topiramate. CONCLUSIONS The results of this study support the efficacy of topiramate in the relapse prevention of alcoholism. Suggestive evidence was also obtained for superiority of topiramate versus naltrexone, but this needs to be verified in future research with larger sample sizes.