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Baclofen in the Treatment of Alcohol Dependence With or Without Alcoholic Liver Disease (BacALD)

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ClinicalTrials.gov Identifier: NCT01711125
Recruitment Status : Completed
First Posted : October 22, 2012
Last Update Posted : August 8, 2017
Sponsor:
Collaborators:
National Health and Medical Research Council, Australia
University of Sydney
Information provided by (Responsible Party):
Professor Paul Haber, South West Sydney Local Health District

Brief Summary:
To explore the effectiveness and biobehavioural basis of baclofen in improving treatment outcomes for alcohol dependence in people with or without alcoholic cirrhosis in a double-blind randomised placebo-controlled trial.

Condition or disease Intervention/treatment Phase
Alcoholic Liver Disease Alcohol Dependence Drug: Baclofen 30mg/day Drug: Baclofen 75mg/day Drug: Placebo Phase 3

Detailed Description:

This is a double-blind randomised placebo-controlled study investigating the efficacy of baclofen for the treatment of alcohol dependence in patients with alcoholic liver disease. Medications will be given for 12 weeks, with a further 6 months follow-up. Both male and female participants will be recruited to this study. Trial patients will be randomised to one of three treatment groups: (1) baclofen 30mg/day (10 mg t.i.d), (2) baclofen 75mg/day (25 mg t.i.d) or (3) Placebo (3 matched tabs/day).

This study will also include a second, parallel group of patients with alcohol dependence (non alcoholic-liver disease patients) that will undergo the trial protocol as described above. These patients will be randomised according to a separate list into one of three treatment groups: (1) baclofen 30mg/day (10 mg t.i.d), (2) baclofen 75mg/day (25 mg t.i.d) or (3) Placebo (3 matched tabs/day).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Exploring the Efficacy and Biobehavioural Basis of Baclofen in the Treatment of Alcoholic Liver Disease
Study Start Date : March 2013
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Baclofen

Arm Intervention/treatment
Experimental: Arm 1
Baclofen low dose
Drug: Baclofen 30mg/day
30mg/day 10 mg t.i.d

Experimental: Arm 2
Baclofen high dose
Drug: Baclofen 75mg/day
75mg/day 25 mg t.i.d

Placebo Comparator: Arm 3
Placebo
Drug: Placebo
Placebo 3 matched tabs/day




Primary Outcome Measures :
  1. alcohol consumption [ Time Frame: 12 weeks ]
    as measured by the number of days abstinent, number of heavy drinking days, time to relapse, time to lapse and number of drinks per drinking day


Secondary Outcome Measures :
  1. clinical markers of liver injury [ Time Frame: 12 weeks ]
  2. incidence of hepatic side effects [ Time Frame: 12 weeks ]
  3. craving for alcohol [ Time Frame: 12 weeks ]
  4. early termination due to side effects [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ALD (for trial group 1), defined as the presence of symptoms and/or signs referable to liver disease with or without cirrhosis, in which alcohol use is considered to play a major aetiological role. Alcohol use will have exceeded an average of 60g/day in women and 80g/day in men for >10 years.
  • Alcohol dependence according to the ICD-10 criteria (for both trial 1 and 2)
  • Adequate cognition and English language skills to give valid consent and complete research interviews
  • Willingness to give written informed consent
  • Abstinence from alcohol for between 3 and 21 days
  • Resolution of any clinically evident alcohol withdrawal (CIWA-AR)

Exclusion Criteria:

  • Active major psychological disorder associated with psychosis or significant suicide risk
  • Pregnancy or lactation
  • Concurrent use of any psychotropic medication other than antidepressants
  • Substance use other than nicotine if unstable
  • Clinical evidence of persisting hepatic encephalopathy
  • Pending incarceration
  • Lack of stable housing
  • Active peptic ulcers
  • Unstable diabetes mellitus

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01711125


Locations
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Australia, New South Wales
Drug Health Services, Royal Prince Alfred Hospital
Sydney, New South Wales, Australia, 2050
Sponsors and Collaborators
South West Sydney Local Health District
National Health and Medical Research Council, Australia
University of Sydney
Investigators
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Principal Investigator: Paul S Haber, MBBS Sydney Local Health District
Principal Investigator: Andrew Baillie, PhD Macquarie University
Principal Investigator: Kirsten C Morley, PhD University of Sydney

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Professor Paul Haber, Clinica Director, South West Sydney Local Health District
ClinicalTrials.gov Identifier: NCT01711125     History of Changes
Other Study ID Numbers: X11-0154
First Posted: October 22, 2012    Key Record Dates
Last Update Posted: August 8, 2017
Last Verified: August 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Liver Diseases
Liver Diseases, Alcoholic
Alcoholism
Digestive System Diseases
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Alcohol-Induced Disorders