Who is sponsoring GATE I?

GATE I is sponsored by Catholic University of the Sacred Heart.

What condition does GATE I study?

GATE I studies Alcohol Withdrawal Syndrome, Alcohol Dependence.

What drugs are being tested in GATE I?

Interventions: Sodium Oxybate (SMO), Oxazepam.

Last reviewed 2014-03-17 · How we verify

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

NCT02090504 Phase 4 COMPLETED

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).

Details

Lead sponsor	Catholic University of the Sacred Heart
Phase	Phase 4
Status	COMPLETED
Enrolment	127
Start date	2002-02
Completion	2009-05

Conditions

Alcohol Withdrawal Syndrome
Alcohol Dependence

Interventions

Sodium Oxybate (SMO)
Oxazepam

Primary outcomes

Efficacy of GHB compared to oxazepam on alcohol withdrawal symptoms — day 1, day 10, day 20
The primary outcome was the reduction of symptoms of AWS reflected by the course of the total CIWA-Ar scores from the start (baseline) to the end of the study (day 10) and to the end of follow up (day 20, 10 days after drugs discontinuation).

Countries

Austria, Italy