A Randomized Controlled Clinical Trial of the Neuroimmune Modulator Ibudilast for the Treatment of Alcohol Use Disorder

  • STATUS
    Recruiting
  • End date
    Mar 22, 2023
  • participants needed
    132
  • sponsor
    University of California, Los Angeles
Updated on 22 October 2022

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.

Description

The study design consists of a 12-week, double-blind, placebo-controlled randomized clinical trial of IBUD (50mg BID) for the treatment of Alcohol Use Disorder (AUD). The investigators will randomize 132 treatment-seekers with current AUD over the course of 4 years. As a behavioral support platform, all participants will complete the NIAAA-developed and computer-delivered program "Take Control" during the study. 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. 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 ECG.

Details
Condition Alcohol Use Disorder
Treatment Placebo oral capsule, ibudilast
Clinical Study IdentifierNCT03594435
SponsorUniversity of California, Los Angeles
Last Modified on22 October 2022

Eligibility

Yes No Not Sure

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
Have attempted suicide in the past 3 years and/or have had serious suicidal intention or plan in the past year
diabetes)
Currently be on prescription medication that contraindicates use of IBUD, including alpha or beta agonists, theophylline, or other sympathomimetic
Have AST, ALT, or GGT ≥ 3 times upper normal limit
Have any other circumstances that, in the opinion of the investigators, compromises participant safety
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)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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