Efficacy of Baclofen in the Treatment of Alcohol Addiction

Study Overview
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Brief Summary
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Intervention to achieve alcohol abstinence represents the most effective treatment for alcoholic patients with liver cirrhosis. However no trials have evaluated the efficacy of anti-craving drugs in these patients because of the concern that these medications might worsen liver disease. Baclofen is effective to reduce alcohol craving improving abstinence in alcohol-dependent patients. It is mainly eliminated by kidney. No hepatic side-effects have been reported in treated patients. The present study investigates the efficacy and safety of baclofen in achieving and maintaining abstinence in alcoholic cirrhotic patients.

Official Title
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Maintaining Alcohol Abstinence in Alcoholic Patients With Liver Cirrhosis: Efficacy and Safety of Baclofen Administration in a Randomized Double Blind Controlled Study

Conditions
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Liver Cirrhosis, Alcoholic

Intervention / Treatment
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* Drug: Baclofen
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age ranging from 18 to 75 years diagnosis of alcohol dependence according to DSM IV criteria diagnosis of liver cirrhosis alcohol intake of at least 2 heavy drinking days (men > 5 drinks/days; women > 4 drinks/day) per week, on average and an average overall consumption of 21 drinks/week or more for men and 14 drinks/week or more for women during the 4 weeks prior to enrolment presence of a referred family member Exclusion Criteria: severe heart or lung disease kidney alterations and/or hepato-renal syndrome tumours, including hepatocellular carcinoma metabolic diseases, including diabetes clinical signs of hepatic encephalopathy patients treated with interferon or corticosteroids within the last 60 days psychopathological illness undergoing treatment with psychoactive drugs epilepsy or epileptiform convulsions addiction to drugs other than nicotine

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 2<br>A total of 42 alcoholic patients with liver cirrhosis treated with placebo | Drug: placebo<br>* Placebo will be orally administered for 12 consecutive weeks<br>|
| Active Comparator: 1<br>a total of 42 alcoholic patients with liver cirrhosis treated by baclofen | Drug: Baclofen<br>* Baclofen orally administered for 12 consecutive weeks. For the first 3 days, baclofen administered at a dose of 5 milligrams 3 times per day; subsequently, the daily dose of baclofen will be increased to 10 milligrams 3 times per day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total alcohol abstinence; cumulative abstinence duration |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Obsessive and Compulsive craving |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liver cirrhosis, Alcoholism, Craving