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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

316 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2014-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Alcohol Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Baclofen

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

Group Type EXPERIMENTAL

Baclofen

Intervention Type DRUG

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo (for baclofen)

Intervention Type DRUG

Interventions

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Baclofen

Intervention Type DRUG

Placebo (for baclofen)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No