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Efficacy of Baclofen in the Treatment of Alcohol Addiction

Primary Purpose

Liver Cirrhosis, Alcoholic

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Baclofen
placebo
Sponsored by
Catholic University of the Sacred Heart
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cirrhosis, Alcoholic focused on measuring Liver cirrhosis, Alcoholism, Craving

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Active Comparator

    Arm Label

    2

    1

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Total alcohol abstinence; cumulative abstinence duration

    Secondary Outcome Measures

    Obsessive and Compulsive craving

    Full Information

    First Posted
    September 4, 2007
    Last Updated
    September 4, 2007
    Sponsor
    Catholic University of the Sacred Heart
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00525252
    Brief Title
    Efficacy of Baclofen in the Treatment of Alcohol Addiction
    Official Title
    Maintaining Alcohol Abstinence in Alcoholic Patients With Liver Cirrhosis: Efficacy and Safety of Baclofen Administration in a Randomized Double Blind Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2007
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2003 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    November 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Catholic University of the Sacred Heart

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Liver Cirrhosis, Alcoholic
    Keywords
    Liver cirrhosis, Alcoholism, Craving

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    86 (false)

    8. Arms, Groups, and Interventions

    Arm Title
    2
    Arm Type
    Placebo Comparator
    Arm Description
    A total of 42 alcoholic patients with liver cirrhosis treated with placebo
    Arm Title
    1
    Arm Type
    Active Comparator
    Arm Description
    a total of 42 alcoholic patients with liver cirrhosis treated by baclofen
    Intervention Type
    Drug
    Intervention Name(s)
    Baclofen
    Intervention Description
    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
    Intervention Name(s)
    placebo
    Intervention Description
    Placebo will be orally administered for 12 consecutive weeks
    Primary Outcome Measure Information:
    Title
    Total alcohol abstinence; cumulative abstinence duration
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Obsessive and Compulsive craving
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Giovanni Addolorato, M.D.
    Organizational Affiliation
    Catholic University of Rome
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    12217947
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    18068515
    Citation
    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.
    Results Reference
    derived

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    Efficacy of Baclofen in the Treatment of Alcohol Addiction

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