Efficacy of Baclofen in the Treatment of Alcohol Addiction

• Status: Completed
• Trial end date: 2006-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Catholic University of the Sacred Heart
• Treatments: Baclofen

Criteria

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