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Efficacy of Baclofen in the Treatment of Alcohol Addiction

NCT ID: NCT00525252

Last Updated: 2007-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2006-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Liver Cirrhosis, Alcoholic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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2

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

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Placebo will be orally administered for 12 consecutive weeks

1

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

Group Type ACTIVE_COMPARATOR

Baclofen

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

placebo

Placebo will be orally administered for 12 consecutive weeks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Catholic University of the Sacred Heart

OTHER

Sponsor Role lead

Principal Investigators

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Giovanni Addolorato, M.D.

Role: PRINCIPAL_INVESTIGATOR

Catholic University of Rome

References

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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. doi: 10.1093/alcalc/37.5.504.

Reference Type BACKGROUND
PMID: 12217947 (View on PubMed)

Addolorato G, Leggio L, Ferrulli A, Cardone S, Vonghia L, Mirijello A, Abenavoli L, D'Angelo C, Caputo F, Zambon A, Haber PS, Gasbarrini G. Effectiveness and safety of baclofen for maintenance of alcohol abstinence in alcohol-dependent patients with liver cirrhosis: randomised, double-blind controlled study. Lancet. 2007 Dec 8;370(9603):1915-22. doi: 10.1016/S0140-6736(07)61814-5.

Reference Type DERIVED
PMID: 18068515 (View on PubMed)

Other Identifiers

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Bacl001

Identifier Type: -

Identifier Source: org_study_id