Efficacy of Baclofen in the Treatment of Alcohol Addiction

Catholic University of the Sacred Heart

Status and phase: Completed; Phase 2; Phase 1

Conditions: Liver Cirrhosis, Alcoholic

Treatments: Drug: placebo; Drug: Baclofen

Study type: Interventional

Funder types: Other

Identifiers

NCT00525252

Bacl001

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

86 participants in 2 patient groups, including a placebo group

2

Placebo Comparator group

Description:

A total of 42 alcoholic patients with liver cirrhosis treated with placebo

Treatment:

Drug: placebo

1

Active Comparator group

Description:

a total of 42 alcoholic patients with liver cirrhosis treated by baclofen

Treatment:

Drug: Baclofen