Efficacy of Baclofen in the Treatment of Alcohol Addiction - Full Text View

Sponsor:	Catholic University of the Sacred Heart
Information provided by:	Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:	NCT00525252

Purpose

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.

Condition	Intervention	Phase
Liver Cirrhosis, Alcoholic	Drug: Baclofen Drug: placebo	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Maintaining Alcohol Abstinence in Alcoholic Patients With Liver Cirrhosis: Efficacy and Safety of Baclofen Administration in a Randomized Double Blind Controlled Study

Resource links provided by NLM:

MedlinePlus related topics: Alcoholism Cirrhosis

Drug Information available for: Baclofen

U.S. FDA Resources

Further study details as provided by Catholic University of the Sacred Heart:

Primary Outcome Measures:

Total alcohol abstinence; cumulative abstinence duration [ Time Frame: 12 weeks ]

Secondary Outcome Measures:

Obsessive and Compulsive craving [ Time Frame: 12 weeks ]

Estimated Enrollment:	86
Study Start Date:	February 2003
Study Completion Date:	November 2006

Arms	Assigned Interventions
2: Placebo Comparator A total of 42 alcoholic patients with liver cirrhosis treated with placebo	Drug: placebo Placebo will be orally administered for 12 consecutive weeks
1: Active Comparator a total of 42 alcoholic patients with liver cirrhosis treated by baclofen	Drug: 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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00525252

Sponsors and Collaborators

Catholic University of the Sacred Heart

Investigators

Principal Investigator:

Giovanni Addolorato, M.D.

Catholic University of Rome

More Information

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.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Study ID Numbers:	Bacl001
Study First Received:	September 4, 2007
Last Updated:	September 4, 2007
ClinicalTrials.gov Identifier:	NCT00525252 History of Changes
Health Authority:	Italy: Ethics Committee

Keywords provided by Catholic University of the Sacred Heart:

Liver cirrhosis
Alcoholism
Craving

Additional relevant MeSH terms:

Alcohol-Induced Disorders
Neurotransmitter Agents
Liver Diseases
Molecular Mechanisms of Pharmacological Action
Fibrosis
Physiological Effects of Drugs
Baclofen
Disorders of Environmental Origin
Neuromuscular Agents
Liver Cirrhosis
Pharmacologic Actions
Liver Diseases, Alcoholic

Digestive System Diseases
Pathologic Processes
GABA Agonists
Therapeutic Uses
Muscle Relaxants, Central
Substance-Related Disorders
GABA Agents
Alcohol-Related Disorders
Peripheral Nervous System Agents
Central Nervous System Agents
Liver Cirrhosis, Alcoholic

ClinicalTrials.gov processed this record on November 05, 2009