Efficacy of Baclofen in the Treatment of Alcohol Addiction

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.

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Key information

Conditions

Liver Cirrhosis, Alcoholic Alcohol-Induced Disorders Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Digestive System Diseases Fibrosis Liver Cirrhosis Liver Diseases Liver Diseases, Alcoholic Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Substance-Related Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Baclofen

Drug

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

Drug

Placebo will be orally administered for 12 consecutive weeks

Primary outcomes

Total alcohol abstinence; cumulative abstinence duration

Time frame: 12 weeks

Secondary outcomes

Obsessive and Compulsive craving

Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Catholic University of the Sacred Heart

Other

Registry information

Official study title

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

Important dates

Study start: 2003
Study completion: 2006
First posted: Sep 5, 2007
Registry last updated: Sep 5, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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