Ibudilast for the Treatment of Alcohol Use Disorder

Alcohol Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03594435
• Other study ID #: 18-000963
• Secondary ID: R01AA026190
• Status: Completed
• Phase: Phase 2
• Start date: October 1, 2018
• Est. completion date: April 19, 2023

Study information

• Verified date: April 2024
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: April 19, 2023
• Est. primary completion date: April 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism

Intervention

Drug:
• Ibudilast
targets neurotrophin signaling and neuroimmune function
• Placebo oral capsule
matched to active drug, ibudilast

Locations

Country	Name	City	State
United States	UCLA Addictions Laboratory	Los Angeles	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, Los Angeles	MediciNova, National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Depressive Symptomatology	Responses from Beck Depression Inventory II (BDI-II) will be used to test this outcome	12-week treatment period
Other	Neuroinflammation	Blood levels of proinflammatory markers	12-week treatment period
Primary	Percent heavy drinking days	Heavy drinking days defined as 5+ drinks for men and 4+ for women	12 week-treatment period
Secondary	Drinks per day	secondary alcohol consumption endpoint	12-week treatment period
Secondary	Drinks per drinking day	secondary alcohol consumption endpoint	12-week treatment period
Secondary	Percent days abstinent	secondary alcohol consumption endpoint	12-week treatment period
Secondary	Percent subjects with no heavy drinking days	secondary alcohol consumption endpoint	12-week treatment period
Secondary	Percent subjects abstinent	secondary alcohol consumption endpoint	12-week treatment period