Ibudilast for the Treatment of Alcohol Use Disorder

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Alcohol Use Disorder

Intervention / Treatment
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* Drug: Ibudilast
* Drug: Placebo oral capsule


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two-Arm, Randomized, Double-Blind, Placebo-Controlled
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ibudilast<br>10mg delayed-release capsules, target dose 50mg BID (5 x 10mg capsules twice daily) for 12 weeks | Drug: Ibudilast<br>* targets neurotrophin signaling and neuroimmune function<br>* Other names: MN-166;|
| Placebo Comparator: Placebo Oral Capsule<br>matched to experimental drug | Drug: Placebo oral capsule<br>* matched to active drug, ibudilast<br>* Other names: Sugar Pill;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent heavy drinking days | Heavy drinking days defined as 5+ drinks for men and 4+ for women | 12 week-treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drinks per day | secondary alcohol consumption endpoint | 12-week treatment period | 
| Drinks per drinking day | secondary alcohol consumption endpoint | 12-week treatment period | 
| Percent days abstinent | secondary alcohol consumption endpoint | 12-week treatment period | 
| Percent subjects with no heavy drinking days | secondary alcohol consumption endpoint | 12-week treatment period | 
| Percent subjects abstinent | secondary alcohol consumption endpoint | 12-week treatment period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ibudilast, treatment, medication development