title: An open multicentric study evaluating 4-hydroxybutyric acid sodium salt in the medium-term treatment of 179 alcohol dependent subjects. GHB Study Group.
abstract: We report the results of an "open' multicentre study evaluating the use, tolerability and therapeutic efficacy of the sodium salt of 4-hydroxybutyric acid (GHB) for the medium-term treatment of withdrawal symptoms in 179 patients with alcohol dependence followed up as outpatients. The follow-up of patients was 6 and 12 months after drug discontinuation. Following a daily oral administration of 50 mg/kg for approximately 6 months, no serious systemic or single-organ consequences leading to drug discontinuation were reported, and tolerability was fair in all patients. Eleven subjects (10.1%) showed craving for the drug and voluntarily increased their doses (6-7 times the recommended levels). GHB led to complete abstinence during drug administration in 78.0% of the patients. A significant reduction of compulsive desire ("craving') was observed in parallel, as deduced from evaluation of a specific questionnaire, 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.
authors.affiliation: Internal Medicine II Chair, Catholic University Sacro Cuore, Rome, Italy.
authors.forename: G
authors.initials: G
authors.lastname: Addolorato
authors.forename: E
authors.initials: E
authors.lastname: Castelli
authors.forename: G F
authors.initials: GF
authors.lastname: Stefanini
authors.forename: G
authors.initials: G
authors.lastname: Casella
authors.forename: F
authors.initials: F
authors.lastname: Caputo
authors.forename: L
authors.initials: L
authors.lastname: Marsigli
authors.forename: M
authors.initials: M
authors.lastname: Bernardi
authors.forename: G
authors.initials: G
authors.lastname: Gasbarrini
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000430:Alcohol Withdrawal Delirium / Q000175:diagnosis / Q000534:rehabilitation; D000437:Alcoholism / Q000534:rehabilitation*; D004305:Dose-Response Relationship, Drug; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009460:Neurologic Examination / Q000187:drug effects; D012978:Sodium Oxybate / Q000009:adverse effects / Q000627:therapeutic use*; D013695:Temperance / Q000523:psychology
chemical_list: D012978:Sodium Oxybate