Efficacy and Safety of Baclofen for Maintenance of Abstinence in Alcohol Dependent Patients

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to assess the efficacy of Xylka® (baclofen) compared to placebo on continuous abstinence rate during 20 weeks of treatment, after withdrawal, in alcohol dependent patients receiving Brenda therapy sessions.

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

Details

• Lead Sponsor: Ethypharm
• Treatments: Baclofen; Ethanol

Criteria

Inclusion Criteria:

• Adult patients meeting DSM IV(Diagnosis and Statistical Manual of Mental Disorders, 4th edition) criteria for alcohol dependence

• Willing to participate in the study and express a desire to achieve the objective of continuous and long term abstinence after withdrawal

• Abstinent (last drinking) for a minimum of 3 days and maximum of 14 days

• At least one previous abstinence attempt

Exclusion Criteria:

• Need for a stay at the end of the withdrawal period in a health care and rehabilitation institution specialized in addiction

• Need for a heavy psychosocial out of hospital care

• History of baclofen intake, by prescription or self medication

• Porphyria

• Concomitant treatment with one or several drugs for the maintenance of abstinence

• Severe renal, cardiac or pulmonary disorder

• Epilepsy or history of epilepsy

• Concomitant treatment with psychotropic drugs, except antidepressants at stable dose for 2 months, diazepam and oxazepam

• Severe psychiatric disease (schizophrenia and bipolar disorder)

• Suicidal risk or history of suicide

• Clinically significant cognitive disorders

• Hepatic encephalopathy

• Ongoing dependence or within the last 12 months on other addictive substances (opioid, cocaine, cannabis, other substances or drugs…), excepted tobacco