Evaluation of the Efficacy of Sodium Oxybate in the Long-term Maintenance of Abstinence in Alcoholic Patients

Inclusion Criteria: The following subjects were recruited: * males and females; * of any ethnic group; * age between 21 and 75 years at recruitment; * documented alcohol dependency before weaning detected according to the CAGE instrument, classified according to the DSM-IV and ICD-10 and severity rated according to the MALT instrument; * classified according to Lesch typology; * having successfully undergone a detoxification program, encompassing a 10-day treatment period and a subsequent 10-day untreated follow-up; * with a responsible relative or caregiver; * having issued the informed consent. Exclusion Criteria: * subjects who did not quit alcohol drinking after the detoxification period; * subjects with history of epilepsy or epileptics seizures not properly controlled by established anti-epileptic treatment; * subjects with dependence from narcotics or other drugs of abuse; * subjects without a stable address; * subjects without a reference relative or caregiver; * subjects with renai failure (blood creatinine \>2.5 mg/dL and/or documented proteinuria \>500 mg/day); * subjects with heart failure or severe respiratory failure; * subjects with hepatic encephalopathy stage lI-IV; * subjects with severe psychiatric disorders requiring treatment with psychoactive medications (excluding short-term benzodiazepine treatments); * subjects under treatment with clonidine, disulfiram (after the end of the detoxification period), haloperidol, bromocryptine, serotonine re-uptake inhibitors or other serotoninergic agents; * female subjects who cannot assure not to become pregnant during the 7-month period covering treatment and the first treatment-free month of follow-up; * documented pre-existent hypersensitivity to GHB; * subjects unable or unwilling to issue the informed consent; * participating to another clinica! investigation in the previous month prior to recruitment; 15. any other medicai condition which, according to the investigator, justifies the patient's exclusion from the study.