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Ibudilast for the Treatment of Alcohol Use Disorder

Primary Purpose

Alcohol Use Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ibudilast
Placebo oral capsule
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use Disorder focused on measuring ibudilast, treatment, medication development

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Be between the ages of 18 and 65
  2. Meet current (i.e., past 12 months) DSM-5 diagnostic criteria for alcohol use disorder moderate or severe
  3. Be treatment-seeking for AUD
  4. 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:

  1. Have a current (last 12 months) DSM-5 diagnosis of substance use disorder for any psychoactive substances other than alcohol and nicotine
  2. Have a lifetime DSM-5 diagnosis of schizophrenia, bipolar disorder, or any psychotic disorder
  3. Have a positive urine screen for narcotics, amphetamines, or sedative hypnotics;
  4. Have clinically significant alcohol withdrawal symptoms as indicated by a score ≥ 10 on the Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-R)

  5. 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
  6. Have a medical condition that may interfere with safe study participation (e.g., unstable cardiac, renal, or liver disease, uncontrolled hypertension or diabetes)
  7. Have AST, ALT, or GGT ≥ 3 times upper normal limit
  8. Have attempted suicide in the past 3 years and/or have had serious suicidal intention or plan in the past year
  9. Currently be on prescription medication that contraindicates use of IBUD, including alpha or beta agonists, theophylline, or other sympathomimetic
  10. 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)
  11. Have any other circumstances that, in the opinion of the investigators, compromises participant safety.

Sites / Locations

  • UCLA Addictions Laboratory

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ibudilast

Placebo Oral Capsule

Arm Description

10mg delayed-release capsules, target dose 50mg BID (5 x 10mg capsules twice daily) for 12 weeks

matched to experimental drug

Outcomes

Primary Outcome Measures

Percent heavy drinking days
Heavy drinking days defined as 5+ drinks for men and 4+ for women

Secondary Outcome Measures

Drinks per day
secondary alcohol consumption endpoint
Drinks per drinking day
secondary alcohol consumption endpoint
Percent days abstinent
secondary alcohol consumption endpoint
Percent subjects with no heavy drinking days
secondary alcohol consumption endpoint
Percent subjects abstinent
secondary alcohol consumption endpoint

Full Information

First Posted
July 11, 2018
Last Updated
July 11, 2023
Sponsor
University of California, Los Angeles
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA), MediciNova
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1. Study Identification

Unique Protocol Identification Number
NCT03594435
Brief Title
Ibudilast for the Treatment of Alcohol Use Disorder
Official Title
A Randomized Controlled Clinical Trial of the Neuroimmune Modulator Ibudilast for the Treatment of Alcohol Use Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
April 19, 2023 (Actual)
Study Completion Date
April 19, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA), MediciNova

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder
Keywords
ibudilast, treatment, medication development

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Two-Arm, Randomized, Double-Blind, Placebo-Controlled
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ibudilast
Arm Type
Experimental
Arm Description
10mg delayed-release capsules, target dose 50mg BID (5 x 10mg capsules twice daily) for 12 weeks
Arm Title
Placebo Oral Capsule
Arm Type
Placebo Comparator
Arm Description
matched to experimental drug
Intervention Type
Drug
Intervention Name(s)
Ibudilast
Other Intervention Name(s)
Pinatos, MN-166
Intervention Description
targets neurotrophin signaling and neuroimmune function
Intervention Type
Drug
Intervention Name(s)
Placebo oral capsule
Other Intervention Name(s)
Sugar Pill
Intervention Description
matched to active drug, ibudilast
Primary Outcome Measure Information:
Title
Percent heavy drinking days
Description
Heavy drinking days defined as 5+ drinks for men and 4+ for women
Time Frame
12 week-treatment period
Secondary Outcome Measure Information:
Title
Drinks per day
Description
secondary alcohol consumption endpoint
Time Frame
12-week treatment period
Title
Drinks per drinking day
Description
secondary alcohol consumption endpoint
Time Frame
12-week treatment period
Title
Percent days abstinent
Description
secondary alcohol consumption endpoint
Time Frame
12-week treatment period
Title
Percent subjects with no heavy drinking days
Description
secondary alcohol consumption endpoint
Time Frame
12-week treatment period
Title
Percent subjects abstinent
Description
secondary alcohol consumption endpoint
Time Frame
12-week treatment period
Other Pre-specified Outcome Measures:
Title
Depressive Symptomatology
Description
Responses from Beck Depression Inventory II (BDI-II) will be used to test this outcome
Time Frame
12-week treatment period
Title
Neuroinflammation
Description
Blood levels of proinflammatory markers
Time Frame
12-week treatment period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lara A. Ray, PhD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Addictions Laboratory
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32912290
Citation
Burnette EM, Baskerville WA, Grodin EN, Ray LA. Ibudilast for alcohol use disorder: study protocol for a phase II randomized clinical trial. Trials. 2020 Sep 11;21(1):779. doi: 10.1186/s13063-020-04670-y.
Results Reference
derived

Learn more about this trial

Ibudilast for the Treatment of Alcohol Use Disorder

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