Low-Dose Topiramate in Alcohol Dependence: A Single-Blind, Placebo-Controlled Study

Introduction: Topiramate and anticonvulsants in general are considered safe and effective drugs for the treatment of alcohol dependence, even though topiramate-induced adverse events are quite common, especially for high initial doses or if titration to 300 mg/day is too rapid. The aim of the present study was to assess the efficacy and tolerability profile of low-dose topiramate for relapse prevention. Methods: Following detoxification, 52 patients were randomised into two groups: 26 patients received 100 mg of topiramate (per os, bid, daily), titrated over two weeks, and 26 patients received placebo. Both groups underwent rehabilitation, twice a week. Results: After 6 weeks of treatment, compared to the placebo group, patients receiving topiramate showed: 1) fewer drinking days (p<0.05); 2) less daily alcohol consumption (p<0.05); 3) more days of treatment (p<0.05); 4) reduced levels of craving (OCDS) and withdrawal symptoms (CIWA-Ar); 5) improvement of anxiety, depression and obsessivecompulsive symptom severity (SCL-90-R). Conclusion: Despite the small sample size and the short follow-up period, the present placebo-controlled study demonstrated the potential usefulness of topiramate, even when administered at a dose of 100 mg/day, for the treatment of detoxified alcohol-dependent subjects, confirming results from previous studies testing higher doses of topiramate.