Liver Cirrhosis, Alcoholic
Conditions
Keywords
Liver cirrhosis, Alcoholism, Craving
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.
Interventions
DRUGBaclofen
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.
DRUGplacebo
Placebo will be orally administered for 12 consecutive weeks
Sponsors
Catholic University of the Sacred Heart
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total alcohol abstinence; cumulative abstinence duration | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Obsessive and Compulsive craving | 12 weeks |
Outcome results
None listed