Topiramate (up to 300 mg per day) is more efficacious than placebo as an adjunct to standardised medication compliance management in treatment of alcohol dependence. However, adverse events can limit its use in different clinical situation. In this randomised, double-blind, placebo controlled trial we aimed to investigate the efficacy of low-dosage topiramate on alcohol drinking indices. Craving and psychiatric symptoms improvements were the secondary endpoints.

Forty alcohol dependent subjects where detoxified and subsequently randomised into two groups, respectively receiving topiramate (100mg/die) or Placebo. The level of craving for alcohol was evaluated by a 10-cm Visual Analogue Scale (VAS) and the Italian -version of the Obsessive and Compulsive Drinking Scale (OCDS). Psychiatric symptomatology was evaluated by the Symptom Check List 90 Revised (SCL-90 R).

The improvement of alcohol drinking indices and craving scores was higher in the topiramate group than placebo. The survival function showed that patients treated with topiramate remained abstinent from any alcohol amount for a longer time with respect to placebo (Z= -2.197; P< 0.05). The SCL-90-R general index of “Positive Symptom Total” significantly reduced in the topiramate group (F= 3.41, p< 0.05). The number of patients dropped-out from the study for adverse events was not different between groups.

To our knowledge, this is the first randomised, parallel group trial to evaluate the efficacy of topiramate at low dosage for alcohol dependence. The use of topiramate at low dosage could increase the number of subjects in treatment, given the reduced possibility of adverse events.