Open
Actively Recruiting
Ibudilast for the Treatment of Alcohol Use Disorder
About
Brief Summary
This study is a double-blind, placebo-controlled randomized clinical trial of IBUD (50mg BID) 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.
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
Inclusion Criteria:
- Be between the ages of 18 and 65
- Meet current (i.e., past 12 months) DSM-5 diagnostic criteria for alcohol use disorder moderate or severe
- Be treatment-seeking for 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 AST, ALT, or 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 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.
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Study Stats
Protocol No.
18-000963
Category
Psychology
Principal Investigator
Contact
Location
- UCLA Westwood