Baclofen for the Treatment of Alcohol Dependence (BACLAD)

Charité University Medicine Berlin

Status and phase

Completed

Phase 3

Phase 2

Conditions

Alcohol Dependence

Treatments

Drug: Baclofen

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01266655

BACLAD

Details and patient eligibility

About

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.

Enrollment

56 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

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