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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
Treatment
Study Type
Interventional
Phase
Phase II

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
65 Years

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.

Join this Trial

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Study Stats
Protocol No.
18-000963
Category
Psychology
Contact
Jessica Jenkins
Location
  • UCLA Westwood
For Providers
NCT No.
NCT03594435
For detailed technical eligibility, visit ClinicalTrials.gov.