Development of the Neuroimmune Modulator Ibudilast for the Treatment of Alcoholism: A Randomized, Placebo-Controlled, Human Laboratory Trial
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Current directions in medication development for alcohol use disorder (AUD) emphasize the need to identify novel molecular targets and efficiently screen new compounds aimed at those targets. Ibudilast (IBUD) is a neuroimmune modulator that inhibits phosphodiesterase-4 and -10 and macrophage migration inhibitory factor and was recently found to reduce alcohol intake in rats by ∼50%. To advance medication development for AUD, the present study consists of a randomized, crossover, double-blind, placebo-controlled laboratory study of IBUD in nontreatment-seeking individuals with current (ie, past month) mild-to-severe AUD. This study tested the safety, tolerability, and initial human laboratory efficacy of IBUD (50 mg b.i.d.) on primary measures of subjective response to alcohol as well as secondary measures of cue- and stress-induced changes in craving and mood. Participants (N=24) completed two separate 7-day intensive outpatient protocols that included daily visits for medication administration and testing. Upon reaching a stable target dose of IBUD (or matched placebo), participants completed a stress-exposure session (day 5; PM), an alcohol cue-exposure session (day 6; AM), and an i.v. alcohol administration session (day 6; PM). Participants stayed overnight after the alcohol administration, and discharge occurred on day 7 of the protocol. Medication conditions were separated by a washout period that was ⩾7 days. IBUD was well tolerated; however, there were no medication effects on primary measures of subjective response to alcohol. IBUD was associated with mood improvements on the secondary measures of stress exposure and alcohol cue exposure, as well as reductions in tonic levels of craving. Exploratory analyses revealed that among individuals with higher depressive symptomatology, IBUD attenuated the stimulant and mood-altering effects of alcohol as compared with placebo. Together, these findings extend preclinical demonstrations of the potential utility of IBUD for the treatment of AUD and suggest that depressive symptomatology should be considered as a potential moderator of efficacy for pharmacotherapies with neuroimmune effects, such as IBUD.
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In that study, among those with higher depressive symptoms, ibudilast decreased cravings and mitigated stimulant and mood-altering effects of alcohol compared to placebo.
“particularly among those with higher depressive symptoms, there were decreased cravings and mitigated stimulant and mood-altering effects of alcohol compared to the placebo”
From A Narrative Review of Current and Emerging Trends in the Treatment of Alcohol Use Disorder (2024) · cites this paper as [86]
The Discussion reports that exploratory analyses found ibudilast attenuated alcohol’s stimulant and mood-altering effects among participants with higher depressive symptoms. The Results also report reduced tonic craving versus placebo, but explicitly state that depressive symptoms did not moderate this craving effect. Thus, the claim incorrectly places the craving reduction specifically among those with higher depressive symptoms. (LLM, conf=0.91)
Experimental — accuracy not yet measuredIn a double-blind, placebo-controlled study of 24 individuals with mild-to-severe AUD, ibudilast (50 mg BID) was well tolerated but did not significantly affect subjective responses to alcohol.
“While ibudilast was well tolerated, it did not significantly affect subjective responses to alcohol.”
From A Narrative Review of Current and Emerging Trends in the Treatment of Alcohol Use Disorder (2024) · cites this paper as [86]
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Ray, L. A., & Grodin, E. N. (2021) · Annual Review of Clinical Psychology · doi:10.1146/annurev-clinpsy-081219-114309 · Cited by 18 · see citing works
Self-citationThe effect of neuroimmune modulation on subjective response to alcohol in the natural environment
Meredith, L. R., Grodin, E. N., Montoya, A. K., Miranda, R., Squeglia, L. M., Towns, B., Evans, C., & Ray, L. A. (2022) · Alcoholism: Clinical and Experimental Research · doi:10.1111/acer.14821 · Cited by 12 · see citing works
Self-citation
- Authors
- Ray, L. A., Bujarski, S., Shoptaw, S., Roche, D. J., Heinzerling, K., & Miotto, K.
- Affiliations
- University of California, Los Angeles (US)
- Corresponding author
- Ray, Lara A
- Venue
- Neuropsychopharmacology
- Published
- 2017-01-16
- Volume
- 42
- Issue
- 9
- Pages
- 1776-1788
- ISSN
- 0893-133X (ISSN-L)
- 1740-634X
- PMC
- PMC5520778
- OpenAlex
- W2573993882
- Cited by
- 118
- References
- 82
- Citations by year
- 2026: 5 · 2025: 8 · 2024: 13 · 2023: 8 · 2022: 16 · 2021: 18 · 2020: 14 · 2019: 16 · 2018: 13 · 2017: 7
- FWCI
- 10.71
- Type
- journal article
- Language
- en
- Open access
- green
- europepmc.org
- Licence
- www.springer.com/tdm (tdm)
- Locations
- Neuropsychopharmacology (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- eScholarship (California Digital Library) (submittedVersion)
- Funders
- National Institutes of Health (1ul1rr033176-01, UL1TR000124)
- National Institute on Alcohol Abuse and Alcoholism (F31AA022569, R21AA022214)
- National Center for Research Resources (UL1-RR-033176)
- National Center for Advancing Translational Sciences
- Clinical and Translational Science Institute, University of California, Los Angeles (UL1RR033176, UL1TR000124)
- Topics
- Health Sciences › Medicine › Epidemiology › Substance Abuse Treatment and Outcomes
- Life Sciences › Neuroscience › Cellular and Molecular Neuroscience › Neurotransmitter Receptor Influence on Behavior
- Health Sciences › Medicine › Pathology and Forensic Medicine › Alcohol Consumption and Health Effects
- Keywords
- ibudilast, alcoholism, alcohol craving, subjective response to alcohol, alcohol cue exposure, mood, depressive symptoms, neuroimmunomodulation, phosphodiesterase 4 inhibition, macrophage migration inhibitory factor, pharmacotherapy
- MeSH terms
- Adult, Affect, Alcohol Deterrents, Ethanol, Alcoholism, Central Nervous System Depressants, Depression, Double-Blind Method, Female, Humans, Indolizines, Male, Pyrazoles, Pyridines, Severity of Illness Index, Treatment Outcome, Cross-Over Studies, Craving
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