drugset / Trial / NCT01711125
Baclofen in the Treatment of Alcohol Dependence With or Without Alcoholic Liver Disease
Phase 3
Completed
104 enrolled
South West Sydney Local Health District
National Health and Medical Research Council, Australia · collabUniversity of Sydney · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2013-03
- Primary completion
- 2017-06
- Completion
- 2017-06
Outcome
Met primary endpoint
paper There was a significant effect of baclofen (composite groups) on time to lapse (χ2 = 6.44, P<0.05, Cohen's d = 0.56) PMID 29716670 ↗
paper A significant treatment effect of baclofen was observed for percentage days abstinent (placebo 43%, baclofen 30 mg 69%, baclofen 75 mg 65%; P<0.05). PMID 29716670 ↗
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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Baclofen | Small molecule | 30 mg | — |
| Subject | Baclofen | Small molecule | 75 mg | — |