Comparative Study of Gamma-hydroxy Butyrate Versus Oxazepam in the Treatment of Alcohol Withdrawal Syndrome

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Benzodiazepines (BDZs) are the gold standard in the treatment of alcohol withdrawal syndrome (AWS). Gamma-Hydroxybutyric acid also known as sodium oxybate (SMO) has been tested as a treatment for AWS with encouraging results. Aim of this phase IV, multicenter randomized double-blind, double dummy study is to evaluate the efficacy of SMO in comparison to oxazepam in the treatment of alcohol withdrawal symptoms (AWS).

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

Details

• Lead Sponsor: Catholic University of the Sacred Heart
• Collaborators: CT Pharmaceutical Industries, Sanremo - Italy; Medical University of Vienna; University of Bologna
• Treatments: Butyric Acid; Ethanol; Oxazepam; Sodium Oxybate

Criteria

Inclusion Criteria:

• age range 21-75,

• diagnosis of alcohol dependence according to DSM-IV criteria

• the presence of AWS as assessed by Clinical Institute Withdrawal Assessment for Alcohol-revised (CIWA-Ar) scale, a scoring system for quantitative evaluation of physical symptoms of AWS.20 Only subjects with a CIWA-Ar score equal to or higher than 10 (defined as moderate or severe AWS requiring pharmacological treatment) were ultimately enrolled in the study.

Exclusion criteria:

• ≤55 kg of body weight;

• history of withdrawal fits within 24 hours pre-study;

• history of epilepsy or epileptics seizures not properly controlled by established anti-epileptic treatment;

• dependence from narcotics, BDZs or other drugs of abuse;

• documented pre-existent hypersensitivity to SMO or to BDZs,

• renal failure (blood creatinine >2•5 mg/dl and/or documented proteinuria >500 mg/die),

• heart failure,

• severe respiratory failure

• hepatic encephalopathy stage II-IV;

• psychiatric disorders requiring treatment with psychoactive medications before the start of the study;

• treatment with clonidine, haloperidol, bromocriptine during the last 3 months prior to participation in the study;

• participation to other clinical investigations in the previous month prior to recruitment;

• females whose could not assure not to become pregnant during the 1 month period of treatment, and during the subsequent 3 weeks;

• subjects without a stable social condition or homeless.