Efficacy of Baclofen in the Treatment of Alcohol Addiction
Information source: Catholic University of the Sacred Heart
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Liver Cirrhosis, Alcoholic
Intervention: Baclofen (Drug); placebo (Drug)
Phase: Phase 1/Phase 2
Status: Completed
Sponsored by: Catholic University of the Sacred Heart Official(s) and/or principal investigator(s):
Giovanni Addolorato, M.D., Principal Investigator, Affiliation: Catholic University of Rome
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.
Clinical Details
Official title: Maintaining Alcohol Abstinence in Alcoholic Patients With Liver Cirrhosis: Efficacy and Safety of Baclofen Administration in a Randomized Double Blind Controlled Study
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Total alcohol abstinence; cumulative abstinence duration
Secondary outcome: Obsessive and Compulsive craving
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Related publications: 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.
Starting date: February 2003
Ending date: November 2006
Last updated: September 4, 2007
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