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

Ethypharm

Status and phase: Completed; Phase 3

Conditions: Alcohol Dependence

Treatments: Drug: Baclofen; Drug: Placebo (for baclofen)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01738282

ALP 2011007/002

Details and patient eligibility

About

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.

Enrollment: 316 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

316 participants in 2 patient groups, including a placebo group

Baclofen

Experimental group

Description:

Baclofen 20mg tablet. Titration:increasing dosage regimen to reach the target dosage of 180 mg (9 tablets)in 7 weeks Maintenance period with a constant dosage during 17 weeks Progressive decrease and stop of study treatment in 2 weeks

Treatment:

Drug: Baclofen

Placebo

Placebo Comparator group

Description:

Placebo tablet Titration:increasing dosage regimen to reach the target dosage of 9 tablets in 7 weeks Maintenance period with a constant dosage during 17 weeks Progressive decrease and stop of study treatment in 2 weeks

Treatment:

Drug: Placebo (for baclofen)