Phase 2
N=102
Ibudilast for the Treatment of Alcohol Use Disorder
Alcohol Use Disorder
Bottom Line
View on ClinicalTrials.gov: NCT03594435 ↗Enrolled (actual)
102
Serious AEs
2.0%
Results posted
Nov 2024
Primary outcome: Primary: Percent Heavy Drinking Days — 67.4777; 65.65447; 53.88376; 42.96028 percent of heavy drinking days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ibudilast (Drug); Placebo oral capsule (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, Los Angeles
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Heavy Drinking Days |
67.4777; 65.65447; 53.88376; 42.96028; 48.57848; 43.54836 | — |
| SECONDARY Drinks Per Day |
5.5569643; 5.0916392; 2.9712639; 2.5307298; 2.9416414; 2.7376672 | — |
| SECONDARY Drinks Per Drinking Day |
7.5702563; 7.5157381; 6.0380129; 4.6825232; 5.1232947; 4.8648040 | — |
| SECONDARY Percent Days Abstinent |
25.28269; 24.28538; 52.10013; 51.24152; 53.49783; 46.76799 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03594435). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.