Ibudilast for Alcoholism

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
University of Pennsylvania Center for Studies of Addiction, Philadelphia, PA
Alcoholism+2 More
Medical management - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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. Ibudilast is a medication used to treat alcoholism.

Eligible Conditions

  • Alcoholism
  • Alcohol Use Disorder

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 6-week treatment period.

6-week treatment period.
Change in the frequency of heavy drinking
Change in the number of abstinent days, heavy drinking days during the last month of treatment.

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Ibudilast
1 of 2
Inactive placebo
1 of 2
Active Control
Non-Treatment Group

50 Total Participants · 2 Treatment Groups

Primary Treatment: Ibudilast · Has Placebo Group · Phase 2

Inactive placeboPlaceboComparator Group · 2 Interventions: Medical management, Placebo · Intervention Types: Behavioral, Drug
IbudilastActiveComparator Group · 2 Interventions: Medical management, Ibudilast · Intervention Types: Behavioral, Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6-week treatment period.
Closest Location: University of Pennsylvania Center for Studies of Addiction · Philadelphia, PA
Photo of Philadelphia 1Photo of Philadelphia 2Photo of Philadelphia 3
2017First Recorded Clinical Trial
4 TrialsResearching Alcoholism
3 CompletedClinical Trials

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
1,797 Previous Clinical Trials
36,108,012 Total Patients Enrolled
23 Trials studying Alcoholism
3,426 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

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a stated goal to reduce drinking to safe levels or to stop drinking.
You are able to read English at an 6th grade or higher level and have no gross cognitive impairment.
You are willing to allow an individual who will know the subject's whereabouts to facilitate follow up during the study.
You are a woman of child-bearing potential (i.e., who has not had a hysterectomy, bilateral oophorectomy, tubal ligation or less than two years postmenopausal) who is not practicing a reliable method of birth control and has not had a hysterectomy, bilateral oophorectomy, tubal ligation, or less than two years postmenopausal.
You are willing to provide informed consent and to complete the study procedures.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.