# A randomized controlled clinical trial of the neuroimmune modulator ibudilast for the treatment of alcohol use disorder

> **NIH NIH R01** · UNIVERSITY OF CALIFORNIA LOS ANGELES · 2020 · $662,196

## Abstract

ABSTRACT
Alcohol use disorder (AUD) is a chronic and relapsing condition for which current pharmacological treatments
are only modestly effective. The development of efficacious medications for AUD remains a high research
priority with recent emphasis on identifying novel molecular targets for AUD treatment and to efficiently screen
new compounds aimed at those targets. Ibudilast (IBUD) has been advanced as a novel addiction
pharmacotherapy that targets neurotrophin signaling and neuroimmune function. IBUD inhibits
phosphodiesterases -4 (PDE4) and -10 (PDE10) and macrophage migration inhibitory factor. To advance
medications development for AUD, our laboratory has recently completed a randomized, double-blind,
placebo-controlled crossover laboratory study of IBUD in non-treatment seeking individuals with current AUD
(R21 AA022214; NCT02025998). This study tested the safety, tolerability, and initial human laboratory efficacy
of IBUD (50mg BID). Results indicated that IBUD was well tolerated and associated with mood improvements
during stress- and alcohol-cue exposures as well as reductions in tonic levels of alcohol craving. Building upon
the strong rationale and preclinical findings for IBUD, along with safety data and early efficacy in human testing
conducted in our laboratory, this proposal seeks to conduct a 12-week, double-blind, placebo controlled
randomized clinical trial of IBUD (50mg BID). We propose to randomize 132 treatment-seeking men and
women with current AUD. The primary aims are (a) to test whether IBUD (50mg BID) will decrease percent
heavy drinking days (PHDD; HDD defined as 5+ drinks for men and 4+ for women), as compared to placebo,
over the course of the 12-week trial; and (b) to test the efficacy of IBUD (50mg BID) on secondary alcohol
consumption endpoints, namely (a) drinks per day, (b) drinks per drinking day, (c) percent days abstinent, (d)
percent subjects with no heavy drinking days, and (e) percent subjects abstinent, as well as measures of
alcohol craving and negative mood, over the course of the 12-week trial. The successful completion of the
proposed study will further develop IBUD, a safe and promising novel compound with strong preclinical and
safety data for AUD. If IBUD proves superior to placebo in this study, it will set the stage for a confirmatory
multi-site trial leading to FDA approval of a novel AUD treatment.

## Key facts

- **NIH application ID:** 9883692
- **Project number:** 5R01AA026190-03
- **Recipient organization:** UNIVERSITY OF CALIFORNIA LOS ANGELES
- **Principal Investigator:** LARA A. RAY
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $662,196
- **Award type:** 5
- **Project period:** 2018-05-15 → 2022-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9883692

## Citation

> US National Institutes of Health, RePORTER application 9883692, A randomized controlled clinical trial of the neuroimmune modulator ibudilast for the treatment of alcohol use disorder (5R01AA026190-03). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9883692. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*