AN OPEN MULTICENTRIC STUDY EVALUATING 4-HYDROXYBUTYRIC ACID SODIUM-SALT IN THE MEDIUM-TERM TREATMENT OF 179 ALCOHOL-DEPENDENT SUBJECTS

We report the results of an 'open' multicentre study evaluating the us e, tolerability and therapeutic efficacy of the sodium salt of 4-hydro xybutyric acid (GHB) for the medium-term treatment of withdrawal sympt oms in 179 patients with alcohol dependence followed up as outpatients . The follow-up of patients was 6 and 12 months after drug discontinua tion. Following a daily oral administration of 50 mg/kg for approximat ely 6 months, no serious systemic or single-organ consequences leading to drug discontinuation were reported, and tolerability was fair in a ll patients. Eleven subjects (10.1%) showed craving for the drug and v oluntarily increased their doses (6-7 times the recommended levels). G HB led to complete abstinence during drug administration in 78.0% of t he patients. A significant reduction of compulsive desire ('craving') was observed in parallel, as deduced from evaluation of a specific que stionnaire, the Alcohol Craving Scale. At follow-up examination, 43 of the treated subjects remained abstinent at 6 months, and 30 subjects were abstinent for 1 year after drug discontinuation.