Ibudilast for the Treatment of Alcohol Use Disorder

NCT ID: NCT03594435

Last Updated: 2024-11-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2023-04-19

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.

Detailed Description

The study design consists of a 12-week, double-blind, placebo-controlled randomized clinical trial of IBUD (50mg twice a day) for the treatment of AUD. The investigators will randomize 132 treatment-seekers with current AUD over the course of 4 years. Participants will complete telephone screening, followed by in-person eligibility assessment, a physical exam for medical eligibility, randomization to study medication or matched placebo, and in-person follow-up visits at 4, 8, and 12 weeks of treatment. Timeline Followback (TLFB) assessment of drinking outcomes will also occur by telephone on weeks 2, 6, and 10. A final safety check visit will occur on week 16, consisting of repeated clinical labs and electrocardiography (ECG).

Conditions

Alcohol Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Ibudilast

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

Group Type: EXPERIMENTAL

Ibudilast

Intervention Type: DRUG

targets neurotrophin signaling and neuroimmune function

Placebo Oral Capsule

matched to experimental drug

Group Type: PLACEBO_COMPARATOR

Placebo oral capsule

Intervention Type: DRUG

matched to active drug, ibudilast

Interventions

Ibudilast

targets neurotrophin signaling and neuroimmune function

Intervention Type: DRUG

Placebo oral capsule

matched to active drug, ibudilast

Intervention Type: DRUG

Other Intervention Names

Pinatos; MN-166; Sugar Pill

Eligibility Criteria

Inclusion Criteria

1. Be between the ages of 18 and 65

2. 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

3. Be treatment-seeking for alcohol use disorder (AUD)

4. Report drinking at least 28 drinks per week if male (21 drinks per week if female) in the 28 days prior to consent

Exclusion Criteria

1. Have a current (last 12 months) DSM-5 diagnosis of substance use disorder for any psychoactive substances other than alcohol and nicotine

2. Have a lifetime DSM-5 diagnosis of schizophrenia, bipolar disorder, or any psychotic disorder

3. Have a positive urine screen for narcotics, amphetamines, or sedative hypnotics;

4. Have clinically significant alcohol withdrawal symptoms as indicated by a score ≥ 10 on the Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-R)

5. 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

6. Have a medical condition that may interfere with safe study participation (e.g., unstable cardiac, renal, or liver disease, uncontrolled hypertension or diabetes)

7. Have aspartate aminotransferase (AST), alanine transaminase (ALT), or gamma-glutamyl transferase (GGT) ≥ 3 times upper normal limit

8. Have attempted suicide in the past 3 years and/or have had serious suicidal intention or plan in the past year

9. Currently be on prescription medication that contraindicates use of ibudilast (IBUD), including alpha or beta agonists, theophylline, or other sympathomimetic

10. Currently be on any medications for AUD or any psychotropic medications (e.g., psychostimulants and benzodiazepines) with the exception of stable antidepressants (stable dose for ≥4 weeks)

11. Have any other circumstances that, in the opinion of the investigators, compromises participant safety.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

MediciNova

INDUSTRY

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Lara Ray, PhD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lara A. Ray, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

UCLA Addictions Laboratory

Los Angeles, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 40305022 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32912290 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R01AA026190

Identifier Type: NIH

Identifier Source: secondary_id

View Link

18-000963

Identifier Type: -

Identifier Source: org_study_id