Efficacy of Baclofen in the Treatment of Alcohol Addiction

Liver Cirrhosis, Alcoholic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00525252
• Other study ID #: Bacl001
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 4, 2007
• Last updated: September 4, 2007
• Start date: February 2003
• Est. completion date: November 2006

Study information

• Verified date: September 2007
• Source: Catholic University of the Sacred Heart
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Cirrhosis
• Liver Cirrhosis, Alcoholic

Intervention

Drug:
• Baclofen
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.
• placebo
Placebo will be orally administered for 12 consecutive weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart

References & Publications (1)

Addolorato G, Caputo F, Capristo E, Domenicali M, Bernardi M, Janiri L, Agabio R, Colombo G, Gessa GL, Gasbarrini G. Baclofen efficacy in reducing alcohol craving and intake: a preliminary double-blind randomized controlled study. Alcohol Alcohol. 2002 Sep-Oct;37(5):504-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total alcohol abstinence; cumulative abstinence duration		12 weeks
Secondary	Obsessive and Compulsive craving		12 weeks