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

August 7, 2017 updated by: Professor Paul Haber, South West Sydney Local Health District

Exploring the Efficacy and Biobehavioural Basis of Baclofen in the Treatment of Alcoholic Liver Disease

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2050
        • Drug Health Services, Royal Prince Alfred Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Arm 3
Placebo
Drug: Placebo
Placebo 3 matched tabs/day
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
clinical markers of liver injury
Time Frame: 12 weeks
12 weeks
incidence of hepatic side effects
Time Frame: 12 weeks
12 weeks
craving for alcohol
Time Frame: 12 weeks
12 weeks
early termination due to side effects
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

South West Sydney Local Health District

Collaborators

National Health and Medical Research Council, Australia
University of Sydney

Investigators

  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

October 16, 2012

First Submitted That Met QC Criteria

October 19, 2012

First Posted (Estimate)

October 22, 2012

Study Record Updates

Last Update Posted (Actual)

August 8, 2017

Last Update Submitted That Met QC Criteria

August 7, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • X11-0154

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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