NCT02090504

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

The Gamma Hydroxybutyric Acid in Alcohol-dependence Treatment Efficacy (GATE) I Trial: a Comparative Study Versus Oxazepam in the Treatment of Alcohol Withdrawal Syndrome

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 127 (actual)
• Sponsor: Catholic University of the Sacred Heart · Academic / Other
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This is a phase IV, multicenter randomized (1:1), active drug-controlled study (double-blind, double dummy) with parallel groups evaluating the efficacy of SMO versus oxazepam in the treatment of AWS in alcohol-dependent patients. A placebo-controlled design was considered but excluded, given that a gold standard treatment for AWS is available (i.e., BDZs). Furthermore, considering that SMO and oxazepam have two different pharmaceutical formulation (suspension and tablets, respectively), a double-dummy design was adopted. Thus, all subjects will receive both medications, tablets (oxazepam or placebo) and suspension (SMO or placebo), at the same time.

Conditions

• Alcohol Withdrawal Syndrome
• Alcohol Dependence

Interventions

Type	Name	Description
DRUG	Sodium Oxybate (SMO)
DRUG	Oxazepam

Timeline

• Start date: 2002-02-01
• Primary completion: 2009-04-01
• Completion: 2009-05-01
• First posted: 2014-03-18
• Last updated: 2014-03-18

Locations

3 sites across 2 countries: Austria, Italy