Baclofen for the Treatment of Alcohol Dependence

Phase 2

Completed

• Conditions: Alcohol Dependence
• Interventions: Drug: Placebo; Drug: Baclofen

• Registration Number: NCT01266655
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

There is first evidence from preclinical and clinical studies for the efficacy of the selective GABA-B receptor agonist baclofen in the treatment of alcohol dependence. The aim of this trial is to evaluate the efficacy and safety of individually titrated high-dose baclofen for relapse prevention in alcohol-dependent patients.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-12-23
• Study First Submitted QC: 2010-12-23
• Study First Posted: 2010-12-24
• Study Start: 2011-02
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-04
• Last Update Posted: 2014-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• Diagnosis of alcohol dependence according to ICD-10 (International Classification of Mental and Behavioural Disorders, 10th revision) and DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, 4th revision) criteria
• An alcohol intake of at least two heavy drinking days per week on average (men ≥ 5 drinks per day; women ≥ 4 drinks per day) and an average overall consumption of 21 drinks per week or more for men and 14 drinks per week or more for women during the 4 weeks before detoxification (one standard drink is equal to 12 g absolute alcohol)
• Last alcohol consumption within 7-21 days before randomisation
• Sufficient German language capabilities

Exclusion Criteria

• Pregnancy and/or currently breastfeeding
• Clinical significant medical conditions or observed abnormalities
• Psychiatric illness undergoing treatment with psychoactive drugs
• Epilepsy or epileptiform convulsions
• Addiction to drugs other than nicotine

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Baclofen	Baclofen	-

Primary Outcome Measures

Name	Time	Method
Total abstinence from alcohol and cumulative abstinence duration	13-16 weeks (depending on the individually tolerated baclofen dose)

Secondary Outcome Measures

Name	Time	Method
Number of adverse events	24 weeks

Trial Locations

Locations (1)

Department of Psychiatry, Charité Campus Mitte, Charité - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany