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

A Randomized, Multicentric, Double Blind Study to Assess the Efficacy of Xylka® (Baclofen) at the Target Dosage of 180mg/Day Compared to Placebo, for Maintenance of Abstinence in Alcohol Dependent Patients

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.

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