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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 belowSelect...
I drink more than the recommended amount of alcohol weekly.
Select...
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:Select...
I do not have any significant current illnesses or abnormal lab results.
Select...
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.
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.
Find a Location
Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,079 Previous Clinical Trials
42,721,571 Total Patients Enrolled
27 Trials studying Alcoholism
3,630 Patients Enrolled for Alcoholism
Henry R Kranzler, MDPrincipal InvestigatorUniversity of Pennsylvania
3 Previous Clinical Trials
354 Total Patients Enrolled
2 Trials studying Alcoholism
353 Patients Enrolled for Alcoholism
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any significant current illnesses or abnormal lab results.I am currently taking medication for mental health or alcohol dependence.You have a severe mental illness at the moment.I drink more than the recommended amount of alcohol weekly.I am not breastfeeding, using birth control, and have a negative pregnancy test.You have been diagnosed with Alcohol Use Disorder (AUD) according to the current diagnostic guidelines.Your goal is to either reduce your drinking to safe levels or to completely stop drinking.
Research Study Groups:
This trial has the following groups:- Group 1: Ibudilast
- Group 2: Inactive placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Alcoholism Patient Testimony for trial: Trial Name: NCT05414240 — Phase 2
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