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Alcoholic Liver DiseasePhase 3BacALDNCT01711125

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

A Phase 3 study testing Baclofen 30mg/day and Baclofen 75mg/day in people with Alcoholic Liver Disease and Alcohol Dependence, run by South West Sydney Local Health District at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Alcoholic Liver Disease, Alcohol Dependence
What is being tested?
Baclofen 30mg/day and Baclofen 75mg/day
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
104 participants
Where
1 siteAustralia
Study dates
Mar 2013to Jun 2017
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 9Show fewer
  • Lack of stable housing
  • Active peptic ulcers
  • Unstable diabetes mellitus

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • Drug Health Services, Royal Prince Alfred Hospital

    Sydney, New South Wales, 2050

Other trials in Australia

About this study

Official title: 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.

Read the 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).

Being tested
Baclofen 30mg/day, Baclofen 75mg/day, Placebo
Medical subject headings
Liver Diseases, Alcoholic, Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Baclofen 30mg/dayDrug

    30mg/day 10 mg t.i.d

  • Baclofen 75mg/dayDrug

    75mg/day 25 mg t.i.d

  • PlaceboDrug

    Placebo 3 matched tabs/day

Study groups in NCT01711125
Study groupRoleWhat they receive
Arm 1ExperimentalBaclofen low dose
Receives: Drug: Baclofen 30mg/day
Arm 2ExperimentalBaclofen high dose
Receives: Drug: Baclofen 75mg/day
Arm 3Placebo comparatorPlacebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 12 weeks

Secondary outcomes (4)

  1. clinical markers of liver injury

    Measured: 12 weeks

  2. incidence of hepatic side effects

    Measured: 12 weeks

  3. craving for alcohol

    Measured: 12 weeks

  4. early termination due to side effects

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2012 (estimated)
  2. Study startMar 2013
  3. Primary completionJun 2017
  4. Study completionJun 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
104 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01711125
Sponsor's protocol ID
X11-0154
Acronym
BacALD
Status last verified
Aug 2017
First submitted
16 Oct 2012
Last updated
8 Aug 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Logge WB, Hurzeler TP, Haber PS, Mealing L, Baillie AJ, Morley KC. Baclofen Modulates Neural Intrinsic Functional Connectivity in Treatment-Seeking Individuals With Alcohol Use Disorder. Alcohol Clin Exp Res (Hoboken). 2026 Jun;50(6):e70332. doi: 10.1111/acer.70332.

    PubMed 42246466

  • 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.

    PubMed 35425938

  • 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.

    PubMed 30788529

  • 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.

    PubMed 30561840

  • 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.

    PubMed 30524317

  • 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.

    PubMed 29716670

  • 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.

    PubMed 23939511

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Baclofen 30mg/day and Baclofen 75mg/day in people with Alcoholic Liver Disease and Alcohol Dependence, run by South West Sydney Local Health District at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

alcohol consumption (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01711125, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2017.

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