Baclofen in the Treatment of Alcohol Dependence With or Without Alcoholic Liver Disease
BacALD
Exploring the Efficacy and Biobehavioural Basis of Baclofen in the Treatment of Alcoholic Liver Disease
1 other identifier
interventional
104
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2013
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 16, 2012
CompletedFirst Posted
Study publicly available on registry
October 22, 2012
CompletedStudy Start
First participant enrolled
March 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedAugust 8, 2017
August 1, 2017
4.3 years
October 16, 2012
August 7, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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
12 weeks
Secondary Outcomes (4)
clinical markers of liver injury
12 weeks
incidence of hepatic side effects
12 weeks
craving for alcohol
12 weeks
early termination due to side effects
12 weeks
Study Arms (3)
Arm 1
EXPERIMENTALBaclofen low dose
Arm 2
EXPERIMENTALBaclofen high dose
Arm 3
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Drug Health Services, Royal Prince Alfred Hospital
Sydney, New South Wales, 2050, Australia
Related Publications (6)
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.
PMID: 35425938DERIVEDLogge 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.
PMID: 30788529DERIVEDMorley 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.
PMID: 30561840DERIVEDHeng 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.
PMID: 30524317DERIVEDMorley 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.
PMID: 29716670DERIVEDMorley 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.
PMID: 23939511DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinica Director
Study Record Dates
First Submitted
October 16, 2012
First Posted
October 22, 2012
Study Start
March 1, 2013
Primary Completion
June 1, 2017
Study Completion
June 1, 2017
Last Updated
August 8, 2017
Record last verified: 2017-08