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

Study Overview
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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.

Official Title
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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

Conditions
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Alcohol Dependence

Intervention / Treatment
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* Drug: Baclofen
* Drug: Placebo (for baclofen)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Baclofen<br>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 | Drug: Baclofen<br> <br> |
| Placebo Comparator: Placebo<br>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 | Drug: Placebo (for baclofen)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Continuous abstinence rate in each group (baclofen or placebo) during 20 weeks of treatment, from Day 29 to Day 168. |  | Day 168 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Continuous abstinence rate from the first intake of study treatment (Day 1) to the end of the maintenance dose period (Day 168), i.e. 24 weeks |  | Day 168 | 
| Continuous abstinence rate from the first intake of study treatment (Day 1) to the end of 4-week post treatment follow up period (Day 210), i.e. 30 weeks |  | Day 210 | 
| Continuous abstinence rate during 20 weeks of treatment (Day 29 to Day 168), according to the severity of alcohol dependence |  | Day 168 | 
| Continuous abstinence rate during 20 weeks of treatment (Day 29 to Day 168), according to the level of drinking before withdrawal (Time Line Follow Back calendar/ World Health Organization criteria for risk of consumption) |  | Day 168 | 
| Drinking characteristics for patients having a relapse between Day 1 and Day 210 | Time to relapse (Day 1 to first drinking day) Time to relapse to first high risk drinking day (>60g for a male, > 40g for a female) Percentage of drinking days from Day 1 to Day 210 Mean number of standard drinks per drinking day and classification according to World Health Organization criteria for the risk of consumption Percentage of high risk drinking days during the maintenance period at the target dosage (Day 50 to Day 168) compared to the percentage of high risk drinking days during the preceding 4 weeks of the withdrawal Percentage of drinking days during the maintenance period at the target dosage (Day 50 to Day 168) compared to the percentage of drinking days during the preceding 4 weeks of the withdrawal | Day 210 | 
| Change in craving, addiction and Quality of Life scales | Clinical Global Impression (CGI), Alcohol dependence Quality of Life (AlQoL9), Obsessive Compulsive Drinking Scale (OCDS), Hospital Anxiety and Depression Scale (HAD), Visual Analogue Scale (VAS) craving scores and liver biomarkers | Day 210 | 
| Recording of safety data | Adverse events, vital signs, biological parameters, ECG and urinary pregnancy test | Day 210 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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baclofene, Alcohol dependence, Maintenance of abstinence