Ibudilast for the Treatment of Alcohol Use Disorder

Summary

This study is a double-blind, placebo-controlled randomized clinical trial of Ibudilast (IBUD) (50mg twice a day) for the treatment of Alcohol Use Disorder (AUD). Eligible participants will undergo a 12-week medication treatment period and 5 in-person visits over 16 weeks.

Timeline

Start

2018-10-01

Primary completion

2023-04-19

Completion

2023-04-19

Outcome

Missed primary endpoint

paper There was no significant difference between ibudilast vs placebo on percentage of heavy drinking days (β = 0.06, SE = 0.08 [95% CI, -0.09 to 0.21]; P = .46). reads as missed primary endpoint PMID 40305022 ↗

release “MediciNova Announces the Presentation of Positive Results from Phase 2 Trial of MN‑166 (ibudilast) in Alcohol Use Disorder” reads as unknown medicinova.com ↗

release “there was no evidence of efficacy of MN-166 treatment for AUD in this study population” reads as missed primary endpoint medicinova.com ↗

release “MN-166 (ibudilast) treatment was not superior to placebo for reducing percent heavy drinking days.” reads as missed primary endpoint medicinova.com ↗

Publications

• McManus KR, Enders C, Kirsch DE, Belnap M, Grodin EN, Ray LA. Peripheral inflammation mediates the relationship between early life stress and alcohol use. Psychopharmacology (Berl). 2026 Jan 28:10.1007/s00213-026-07009-8. doi: 10.1007/s00213-026-07009-8. Online ahead of print.
• Ray LA, Meredith LR, Grodin EN, Belnap MA, Nieto SJ, Baskerville WA, Donato S, Shoptaw SJ, Gillis AJ, Irwin MR, Miotto K, Enders CK. A Neuroimmune Modulator for Alcohol Use Disorder: A Randomized Clinical Trial. JAMA Netw Open. 2025 Apr 1;8(4):e257523. doi: 10.1001/jamanetworkopen.2025.7523.
• Burnette EM, Baskerville WA, Grodin EN, Ray LA. Ibudilast for alcohol use disorder: study protocol for a phase II randomized clinical trial. Trials. 2020 Sep 11;21(1):779. doi: 10.1186/s13063-020-04670-y.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ibudilast	Small molecule	50 mg	—

Indications