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

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Additional pharmacotherapies in the treatment of alcohol dependence are needed. Sodium oxybate showed efficacy in the maintenance of abstinence in alcohol-dependent patients in several small randomized trials of short duration. The aim of the present phase III/IV study is to confirm in a randomized-controlled study the efficacy and safety of oral sodium oxybate in the maintenance of abstinence.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Laboratorio Farmaceutico Ct S.r.l.
• Treatments: Sodium Oxybate

Criteria

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.