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A Neuroimmune Modulator for Alcohol Use Disorder: A Randomized Clinical Trial
Lara A Ray1,2,3, Lindsay R Meredith1, Erica N Grodin1,2,3
1Department of Psychology, University of California at Los Angeles.
JAMA Network Open
|April 30, 2025
Summary
Ibudilast did not prove effective in treating alcohol use disorder (AUD) compared to placebo in a clinical trial. Further research is needed to understand its potential effects and moderators in AUD treatment.
Area of Science:
- Neuroscience
- Pharmacology
- Clinical Trials
Background:
- The neuroimmune system is a potential target for alcohol use disorder (AUD) treatments.
- Ibudilast is a neuroimmune modulator that inhibits phosphodiesterases (PDE) and macrophage migration inhibitory factor (MIF).
Purpose of the Study:
- To evaluate the efficacy of ibudilast compared to placebo for treating moderate to severe alcohol use disorder (AUD).
Main Methods:
- A double-masked, phase 2 randomized clinical trial involving 102 adults with AUD.
- Participants received ibudilast (50 mg twice daily) or placebo for 12 weeks, followed by a 4-week follow-up.
- Primary outcome was the percentage of heavy drinking days; secondary outcomes included drinks per day and days abstinent.
Main Results:
- No significant difference was found between ibudilast and placebo in reducing heavy drinking days (P=.46).
- Secondary efficacy outcomes and peripheral inflammation markers also showed no significant differences.
- Exploratory analyses suggested that baseline depressive symptoms and sex might moderate ibudilast's effects.
Conclusions:
- Ibudilast did not demonstrate efficacy over placebo for treating alcohol use disorder (AUD).
- No significant impact on peripheral inflammation markers was observed.
- Future AUD treatments targeting novel molecular pathways may require consideration of specific patient mechanisms and moderators for efficacy.
