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

Primary Purpose

Alcoholic Liver Disease, Alcohol Dependence

Status
Completed
Phase
Phase 3
Locations
Australia
Study Type
Interventional
Intervention
Baclofen 30mg/day
Baclofen 75mg/day
Placebo
Sponsored by
South West Sydney Local Health District
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcoholic Liver Disease

Eligibility Criteria

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

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

Sites / Locations

  • Drug Health Services, Royal Prince Alfred Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Arm 1

Arm 2

Arm 3

Arm Description

Baclofen low dose

Baclofen high dose

Placebo

Outcomes

Primary Outcome Measures

alcohol consumption
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

clinical markers of liver injury
incidence of hepatic side effects
craving for alcohol
early termination due to side effects

Full Information

First Posted
October 16, 2012
Last Updated
August 7, 2017
Sponsor
South West Sydney Local Health District
Collaborators
National Health and Medical Research Council, Australia, University of Sydney
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1. Study Identification

Unique Protocol Identification Number
NCT01711125
Brief Title
Baclofen in the Treatment of Alcohol Dependence With or Without Alcoholic Liver Disease
Acronym
BacALD
Official Title
Exploring the Efficacy and Biobehavioural Basis of Baclofen in the Treatment of Alcoholic Liver Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
South West Sydney Local Health District
Collaborators
National Health and Medical Research Council, Australia, University of Sydney

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholic Liver Disease, Alcohol Dependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Baclofen low dose
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
Baclofen high dose
Arm Title
Arm 3
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Baclofen 30mg/day
Intervention Description
30mg/day 10 mg t.i.d
Intervention Type
Drug
Intervention Name(s)
Baclofen 75mg/day
Intervention Description
75mg/day 25 mg t.i.d
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo 3 matched tabs/day
Primary Outcome Measure Information:
Title
alcohol consumption
Description
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
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
clinical markers of liver injury
Time Frame
12 weeks
Title
incidence of hepatic side effects
Time Frame
12 weeks
Title
craving for alcohol
Time Frame
12 weeks
Title
early termination due to side effects
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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul S Haber, MBBS
Organizational Affiliation
Sydney Local Health District
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrew Baillie, PhD
Organizational Affiliation
Macquarie University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kirsten C Morley, PhD
Organizational Affiliation
University of Sydney
Official's Role
Principal Investigator
Facility Information:
Facility Name
Drug Health Services, Royal Prince Alfred Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia

12. IPD Sharing Statement

Citations:
PubMed Identifier
35425938
Citation
Morley KC, Louie E, Hurzeler T, Baillie A, Dore G, Phung N, Haber PS. Sex as a Potential Moderator for Baclofen Response in the Treatment of Alcohol Dependence. Front Glob Womens Health. 2022 Mar 29;3:807269. doi: 10.3389/fgwh.2022.807269. eCollection 2022.
Results Reference
derived
PubMed Identifier
30788529
Citation
Logge WB, Morris RW, Baillie AJ, Haber PS, Morley KC. Baclofen attenuates fMRI alcohol cue reactivity in treatment-seeking alcohol dependent individuals. Psychopharmacology (Berl). 2021 May;238(5):1291-1302. doi: 10.1007/s00213-019-05192-5. Epub 2019 Feb 20.
Results Reference
derived
PubMed Identifier
30561840
Citation
Morley KC, Lagopoulos J, Logge W, Baillie A, Adams C, Haber PS. Brain GABA levels are reduced in alcoholic liver disease: A proton magnetic resonance spectroscopy study. Addict Biol. 2020 Jan;25(1):e12702. doi: 10.1111/adb.12702. Epub 2018 Dec 18.
Results Reference
derived
PubMed Identifier
30524317
Citation
Heng S, Jamshidi N, Baillie A, Louie E, Dore G, Phung N, Haber PS, Morley KC. Baclofen Response in Alcohol Dependent Patients Concurrently Receiving Antidepressants: Secondary Analysis From the BacALD Study. Front Psychiatry. 2018 Nov 19;9:576. doi: 10.3389/fpsyt.2018.00576. eCollection 2018.
Results Reference
derived
PubMed Identifier
29716670
Citation
Morley KC, Baillie A, Fraser I, Furneaux-Bate A, Dore G, Roberts M, Abdalla A, Phung N, Haber PS. Baclofen in the treatment of alcohol dependence with or without liver disease: multisite, randomised, double-blind, placebo-controlled trial. Br J Psychiatry. 2018 Jun;212(6):362-369. doi: 10.1192/bjp.2018.13. Epub 2018 May 2.
Results Reference
derived
PubMed Identifier
23939511
Citation
Morley KC, Leung S, Baillie A, Haber PS. The efficacy and biobehavioural basis of baclofen in the treatment of alcoholic liver disease (BacALD): study protocol for a randomised controlled trial. Contemp Clin Trials. 2013 Nov;36(2):348-55. doi: 10.1016/j.cct.2013.08.002. Epub 2013 Aug 9.
Results Reference
derived

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

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