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Anti-inflammatory agent

Ibudilast for Alcohol Use Disorder (Ibudilast Trial)

Phase 2

Recruiting

Led By Henry R Kranzler, MD

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Average weekly ethanol consumption of >24 standard drinks for men and >18 standard drinks for women, with a weekly average of > 2 HDDs during the month before screening

Women of child-bearing potential must be non-lactating and practicing a reliable method of birth control and have a negative urine pregnancy test prior to the initiation of treatment

Must not have

A current, clinically significant physical disease or abnormality based on medical history, physical examination, or routine laboratory evaluation, including direct bilirubin elevations of >110% or a transaminase elevation >300% of normal

Current regular treatment with a psychotropic medication or a medication to treat alcohol dependence

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6-week treatment period.

Summary

This trial is testing whether the anti-inflammatory drug ibudilast can help people with alcohol dependence reduce or stop drinking. The trial will last 6 weeks, and participants will be randomly assigned to receive either ibudilast or a placebo. Ibudilast is not approved by the FDA for use in the United States, but it has been used safely and effectively for many years in Asia.

Who is the study for?

This trial is for adults who drink heavily (over 24 drinks weekly for men, over 18 for women) and want to reduce or stop drinking. They must be physically healthy, not pregnant, able to understand English well, and have no serious mental illness or drug dependence other than alcohol, marijuana or nicotine.

What is being tested?

The study tests Ibudilast's ability to help people cut down or quit drinking by reducing inflammation. Participants will receive either Ibudilast or a placebo alongside counseling for six weeks. The effectiveness of Ibudilast in treating alcohol use disorder is experimental.

What are the potential side effects?

While the side effects specific to this trial are not listed, generally Ibudilast may cause headaches, nausea, dizziness and allergic reactions since it has anti-inflammatory properties.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I drink more than the recommended amount of alcohol weekly.

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I am not breastfeeding, using birth control, and have a negative pregnancy test.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any significant current illnesses or abnormal lab results.

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I am currently taking medication for mental health or alcohol dependence.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6-week treatment period.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6-week treatment period.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-week treatment period. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in the frequency of heavy drinking

Secondary study objectives

Change in the number of abstinent days, heavy drinking days during the last month of treatment.

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: IbudilastActive Control2 Interventions

IBUD at a dosage of 20 mg twice daily for 2 days, with an increase to 50 mg twice daily on day 3. The dosage will remain at 50 mg twice daily through most of the rest of the 6-week treatment period. However, for the last three days of week 6, participants will reduce the dosage gradually to 20 mg twice daily prior to discontinuing it at the end of the treatment period.

Group II: Inactive placeboPlacebo Group2 Interventions

Placebo twice daily for 6-week treatment period. Placebo will match active medication in appearance and size.

0 / 4Eligibility criteria met