Baclofen for the Treatment of Alcohol Dependence

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Charite University, Berlin, Germany
• Treatments: Baclofen

Criteria

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