Ibudilast for the Treatment of Alcohol Use Disorder

NCT03594435 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 18-000963R01AA026190
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alcohol Use Disorder

Keywords

ibudilast, treatment, medication development

Outcome Measures

Primary Outcomes (1)

• Percent Heavy Drinking Days

  Heavy drinking days defined as 5+ drinks for men and 4+ for women. Reported outcome measures are proportions of heavy drinking days.

  12 week-treatment period

Secondary Outcomes (3)

• Drinks Per Day

  12-week treatment period

• Drinks Per Drinking Day

  12-week treatment period

• Percent Days Abstinent

  12-week treatment period

Study Arms (2)

Ibudilast

EXPERIMENTAL

10mg delayed-release capsules, target dose 50mg twice daily (5 x 10mg capsules twice daily) for 12 weeks

Drug: Ibudilast

Placebo Oral Capsule

PLACEBO COMPARATOR

matched to experimental drug

Drug: Placebo oral capsule

Interventions

Ibudilast DRUG

targets neurotrophin signaling and neuroimmune function

Also known as: Pinatos, MN-166

Ibudilast

Placebo oral capsule DRUG

matched to active drug, ibudilast

Also known as: Sugar Pill

Placebo Oral Capsule

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be between the ages of 18 and 65
• Meet current (i.e., past 12 months) Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnostic criteria for alcohol use disorder moderate or severe
• Be treatment-seeking for alcohol use disorder (AUD)
• Report drinking at least 28 drinks per week if male (21 drinks per week if female) in the 28 days prior to consent

You may not qualify if:

• Have a current (last 12 months) DSM-5 diagnosis of substance use disorder for any psychoactive substances other than alcohol and nicotine
• Have a lifetime DSM-5 diagnosis of schizophrenia, bipolar disorder, or any psychotic disorder
• Have a positive urine screen for narcotics, amphetamines, or sedative hypnotics;
• Have clinically significant alcohol withdrawal symptoms as indicated by a score ≥ 10 on the Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-R)
• Be pregnant, nursing, or planning to become pregnant while taking part in the study; and must agree to one of the following methods of birth control (if female), unless she or partner are surgically sterile:
• Oral contraceptives
• Contraceptive sponge
• Patch
• Double barrier
• Intrauterine contraceptive device
• Etonogestrel implant
• Medroxyprogesterone acetate contraceptive injection
• Complete abstinence from sexual intercourse
• Hormonal vaginal contraceptive ring
• Have a medical condition that may interfere with safe study participation (e.g., unstable cardiac, renal, or liver disease, uncontrolled hypertension or diabetes)

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator
• MediciNova: collaborator

Study Sites (1)

UCLA Addictions Laboratory

Los Angeles, California, 90095, United States

Location

Related Publications (3)

• 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. doi: 10.1007/s00213-026-07009-8. Online ahead of print.

  PMID: 41603979 DERIVED

• 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.

  PMID: 40305022 DERIVED

• 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.

  PMID: 32912290 DERIVED

MeSH Terms

Conditions

Alcoholism

Interventions

ibudilast; Sugars

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Carbohydrates

Results Point of Contact

• Title: Dr. Lara Ray
• Organization: University of California Los Angeles

lararay@psych.ucla.edu

310-206-6756

Study Officials

• Lara A. Ray, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Two-Arm, Randomized, Double-Blind, Placebo-Controlled

Study Record Dates

• First Submitted: July 11, 2018
• First Posted: July 20, 2018
• Study Start: October 1, 2018
• Primary Completion: April 19, 2023
• Study Completion: April 19, 2023
• Last Updated: November 27, 2024
• Results First Posted: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)