Comparative Study of Gamma-hydroxy Butyrate Versus Oxazepam in the Treatment of Alcohol Withdrawal Syndrome (GATE I)
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|ClinicalTrials.gov Identifier: NCT02090504|
Recruitment Status : Completed
First Posted : March 18, 2014
Last Update Posted : March 18, 2014
|Condition or disease||Intervention/treatment||Phase|
|Alcohol Withdrawal Syndrome Alcohol Dependence||Drug: Sodium Oxybate (SMO) Drug: Oxazepam||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||127 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Gamma Hydroxybutyric Acid in Alcohol-dependence Treatment Efficacy (GATE) I Trial: a Comparative Study Versus Oxazepam in the Treatment of Alcohol Withdrawal Syndrome|
|Study Start Date :||February 2002|
|Actual Primary Completion Date :||April 2009|
|Actual Study Completion Date :||May 2009|
Experimental: Sodium oxybate (SMO)
Patients randomized to the first arm of the study will receive:
Drug: Sodium Oxybate (SMO)
Other Name: Gamma-hydroxy butyrate (GHB)
Active Comparator: Oxazepam
Patients randomized to the second arm of the study will receive:
- Efficacy of GHB compared to oxazepam on alcohol withdrawal symptoms [ Time Frame: 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).
- Course of alcohol abstinence [ Time Frame: day 1, day 10, day 20 ]Secondary outcome variables included the course of alcohol abstinence. In order to confirm daily alcohol abstinence, a breath analyzer was used. In addition, to define those subjects remaining abstinent throughout the whole treatment period, carbohydrate-deficient transferrin (%CDT) was evaluated at the time of screening and at the end of the treatment period.
- Craving for study drug. [ Time Frame: day 1, day 10, day 20 ]Assessment of craving for the study drug.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02090504
|University of Wien|
|Wien, AT, Austria|
|"G. Fontana" Centre for the Study and Multidisciplinary Treatment of Alcohol Addiction, Department of Clinical Medicine, University of Bologna|
|Bologna, BO, Italy|
|Catholic University of Rome|
|Rome, Rm, Italy, 00168|
|Principal Investigator:||Otto Lesch, MD, Prof.||Department of Psychiatry, University of Wien|
|Study Director:||Giovanni Addolorato, MD||Department of Internal Medicine, Catholic University of Rome|