Efficacy of Baclofen in the Treatment of Alcohol Addiction

Phase 1

Completed

• Conditions: Liver Cirrhosis, Alcoholic
• Interventions: Drug: placebo; Drug: Baclofen

• Registration Number: NCT00525252
• Lead Sponsor: Catholic University of the Sacred Heart

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-02
• Study Completion: 2006-11
• Status Verified: 2007-09
• Study First Submitted: 2007-09-04
• Study First Submitted QC: 2007-09-04
• Last Update Submitted: 2007-09-04
• Study First Posted: 2007-09-05
• Last Update Posted: 2007-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	placebo	A total of 42 alcoholic patients with liver cirrhosis treated with placebo
1	Baclofen	a total of 42 alcoholic patients with liver cirrhosis treated by baclofen

Primary Outcome Measures

Name	Time	Method
Total alcohol abstinence; cumulative abstinence duration	12 weeks

Secondary Outcome Measures

Name	Time	Method
Obsessive and Compulsive craving	12 weeks