Alcohol Dependence Clinical Trial
— GATE IOfficial 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
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).
Status | Completed |
Enrollment | 127 |
Est. completion date | May 2009 |
Est. primary completion date | April 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 21 Years to 75 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Austria | University of Wien | Wien | AT |
Italy | "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 |
Lead Sponsor | Collaborator |
---|---|
Catholic University of the Sacred Heart | CT Pharmaceutical Industries, Sanremo - Italy, Medical University of Vienna, University of Bologna |
Austria, Italy,
Skala K, Caputo F, Mirijello A, Vassallo G, Antonelli M, Ferrulli A, Walter H, Lesch O, Addolorato G. Sodium oxybate in the treatment of alcohol dependence: from the alcohol withdrawal syndrome to the alcohol relapse prevention. Expert Opin Pharmacother. 2014 Feb;15(2):245-57. doi: 10.1517/14656566.2014.863278. Epub 2013 Nov 28. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Craving for study drug. | Assessment of craving for the study drug. | day 1, day 10, day 20 | No |
Primary | Efficacy of GHB compared to oxazepam on alcohol withdrawal symptoms | 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). | day 1, day 10, day 20 | No |
Secondary | Course of alcohol abstinence | 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. | day 1, day 10, day 20 | Yes |
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