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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
Sponsor:
Collaborators:
CT Pharmaceutical Industries, Sanremo - Italy
University of Bologna
Medical University of Vienna
Information provided by (Responsible Party):
Giovanni Addolorato, Catholic University, Italy

Brief 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).

Condition or disease Intervention/treatment Phase
Alcohol Withdrawal Syndrome Alcohol Dependence Drug: Sodium Oxybate (SMO) Drug: Oxazepam Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 127 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sodium oxybate (SMO)

Patients randomized to the first arm of the study will receive:

  • SMO (sodium oxybate 175 mg/ml suspension): 10ml at 8.00 a.m., 10ml at 12.00 p.m., 10ml at 7.00 p.m. from day 1 to day 5, 5ml at 8.00 a.m., 5ml at 12.00 p.m., 5ml at 7.00 pm, on days 6 and 7, and 2.5ml at 8.00 a.m., 2.5 ml at 12.00 p.m., 2.5ml at 7.00 p.m. from day 8 to day 10 (If patient's weight is > 75 kg the dosage will be of 12ml instead of 10 ml, 6ml instead of 5ml, 3 ml instead of 2.5ml);
  • placebo (tablets): 1 tablet at 8.00 a.m., 1 tablet at 12.00 p.m., 1 tablet at 7.00 p.m. from day 1 to day 10.
Drug: Sodium Oxybate (SMO)
Other Name: Gamma-hydroxy butyrate (GHB)

Active Comparator: Oxazepam

Patients randomized to the second arm of the study will receive:

  • OXAZEPAM (tablets): 60mg at 8.00 a.m., 60mg at 12.00 p.m., 90mg at 7.00 p.m. from day 1 to day 5, 30mg at 8.00 a.m., 30mg at 12.00 p.m., 30mg at 7.00 pm, on days 6 and 7, and 15mg at 8.00 a.m., 15mg at 12.00 p.m., 15mg at 7.00 p.m. from day 8 to day 10;
  • placebo (suspension): 10ml at 8.00 a.m., 10ml at 12.00 p.m., 10ml at 7.00 p.m. from day 1 to day 5, 5ml at 8.00 a.m., 5ml at 12.00 p.m., 5ml at 7.00 pm, on days 6 and 7, and 2.5ml at 8.00 a.m., 2.5 ml at 12.00 p.m., 2.5ml at 7.00 p.m. from day 8 to day 10, (If patient's weight is > 75 kg the dosage will be of 12ml instead of 10 ml, 6ml instead of 5ml, 3 ml instead of 2.5ml).
Drug: Oxazepam



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. Craving for study drug. [ Time Frame: day 1, day 10, day 20 ]
    Assessment of craving for the study drug.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
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Austria
University of Wien
Wien, AT, Austria
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, Italy, 00168
Sponsors and Collaborators
Catholic University of the Sacred Heart
CT Pharmaceutical Industries, Sanremo - Italy
University of Bologna
Medical University of Vienna
Investigators
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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
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Giovanni Addolorato, Professor of Internal Medicine, Catholic University, Italy
ClinicalTrials.gov Identifier: NCT02090504    
Other Study ID Numbers: GATE-I
First Posted: March 18, 2014    Key Record Dates
Last Update Posted: March 18, 2014
Last Verified: March 2014
Keywords provided by Giovanni Addolorato, Catholic University, Italy:
alcohol withdrawal syndrome
treatment
sodium oxybate
oxazepam
Additional relevant MeSH terms:
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Syndrome
Alcoholism
Substance Withdrawal Syndrome
Disease
Pathologic Processes
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Sodium Oxybate
Oxazepam
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action