Non-benzodiazepine anticonvulsant agents have been shown to be efficacious treatments for the prevention of alcohol relapse although the FDA has yet approved none of these agents. Several studies have demonstrated topiramate's efficacy in improving drinking behavior and maintaining abstinence. The objective of the present randomised, parallel, placebo-controlled trial was to compare topiramate at low dosage with placebo on alcohol drinking indices and craving in detoxified alcohol dependent subjects. Psychiatric symptomatology, quality of life and clinical global improvement have also been investigated.

Sixty detoxified Alcohol Dependent (DSM-IV-TR) outpatients were recruited and randomly assigned to receive topiramate low dosage (n = 30) or placebo (n = 30). Patients have been evaluated after 30, 90 and 180 days of treatment.

Withdrawal symptomatology was determined by the Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar); craving for alcohol was evaluated by a 10-cm Visual Analogue Scale (VASc) and the Obsessive and Compulsive Drinking Scale (OCDS). Psychiatric symptoms were evaluated with the Symptom Check List 90-Revised (SCL-90-R), quality of life with the QL-INDEX; the Clinical Global Impression (CGI) was also administered.

As to our results, topiramate is more efficacy than placebo on both the improvement of withdrawal symptomatology and the reduction of relapses. Furthermore, it has resulted effective in reducing craving, the severity of global psychopathology and the quality of life.

The data of this pilot study investigate and suggest a possible role for the anticonvulsants agents in the treatment of alcohol dependence. Topiramate could be an alternative option beyond the already approved agents for the treatment of alcohol dependence.