Efficacy of Baclofen in the Treatment of Alcohol Addiction - Tabular View

Tracking Information

First Received Date ^ICMJE

September 4, 2007

Last Updated Date

September 4, 2007

Start Date ^ICMJE

February 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Obsessive and Compulsive craving [ Time Frame: 12 weeks ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Efficacy of Baclofen in the Treatment of Alcohol Addiction

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase I, Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Liver Cirrhosis, Alcoholic

Intervention ^ICMJE

Drug: Baclofen
Drug: placebo

Study Arms / Comparison Groups

Placebo Comparator: A total of 42 alcoholic patients with liver cirrhosis treated with placebo
Active Comparator: a total of 42 alcoholic patients with liver cirrhosis treated by baclofen

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00525252

Responsible Party

Study ID Numbers ^ICMJE

Bacl001

Study Sponsor ^ICMJE

Catholic University of the Sacred Heart

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Giovanni Addolorato, M.D.

Catholic University of Rome

Information Provided By

Catholic University of the Sacred Heart

Verification Date

September 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP