Ibudilast for the Treatment of Alcohol Use Disorder

Phase 2

Completed

Conditions: Alcohol Use Disorder

Interventions: Drug: Ibudilast
Drug: Placebo oral capsule

Registration Number: NCT03594435

Lead Sponsor: University of California, Los Angeles

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).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 102

Inclusion Criteria

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

Exclusion Criteria

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)
Have aspartate aminotransferase (AST), alanine transaminase (ALT), or gamma-glutamyl transferase (GGT) ≥ 3 times upper normal limit
Have attempted suicide in the past 3 years and/or have had serious suicidal intention or plan in the past year
Currently be on prescription medication that contraindicates use of ibudilast (IBUD), including alpha or beta agonists, theophylline, or other sympathomimetic
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)
Have any other circumstances that, in the opinion of the investigators, compromises participant safety.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ibudilast	Ibudilast	10mg delayed-release capsules, target dose 50mg twice daily (5 x 10mg capsules twice daily) for 12 weeks
Placebo Oral Capsule	Placebo oral capsule	matched to experimental drug

Primary Outcome Measures

Name	Time	Method
Percent Heavy Drinking Days	12 week-treatment period	Heavy drinking days defined as 5+ drinks for men and 4+ for women. Reported outcome measures are proportions of heavy drinking days.

Secondary Outcome Measures

Name	Time	Method
Drinks Per Day	12-week treatment period	Secondary alcohol consumption endpoint. Outcome measure reported is the proportion of drinks per day. Drinks per day across the trial. Randomization is the first day of study intervention after study eligibility was determined.
Drinks Per Drinking Day	12-week treatment period	Secondary alcohol consumption endpoint. Drinks per drinking day is defined as how many drinks an individual consumed on a day they reported drinking alcohol.
Percent Days Abstinent	12-week treatment period	Secondary alcohol consumption endpoint. Outcome measure reported is the proportion of percent days abstinent.