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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-week treatment period.
Awards & highlights

Ibudilast Trial 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.Check my eligibility
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.See study design
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.

Ibudilast Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I drink more than the recommended amount of alcohol weekly.
Select...
I am not breastfeeding, using birth control, and have a negative pregnancy test.

Ibudilast Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in the frequency of heavy drinking
Secondary outcome measures
Change in the number of abstinent days, heavy drinking days during the last month of treatment.

Ibudilast 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
2,005 Previous Clinical Trials
42,882,159 Total Patients Enrolled
26 Trials studying Alcoholism
3,600 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

Ibudilast (Anti-inflammatory agent) Clinical Trial Eligibility Overview. Trial Name: NCT05414240 — Phase 2
Alcoholism Research Study Groups: Ibudilast, Inactive placebo
Alcoholism Clinical Trial 2023: Ibudilast Highlights & Side Effects. Trial Name: NCT05414240 — Phase 2
Ibudilast (Anti-inflammatory agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05414240 — Phase 2
Alcoholism Patient Testimony for trial: Trial Name: NCT05414240 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the eligibility criteria for this trial encompass individuals aged 30 or over?

"This clinical trial is open to individuals aged 18 and above, up until the age of 70."

Answered by AI

Who is eligible to join this clinical experiment?

"This clinical trial is enrolling individuals aged between 18 and 70 who are suffering from alcoholism. Applicants must be clinically healthy, fulfill DSM-5 criteria for Alcohol Use Disorder (AUD), consume more than 24 standard drinks per week on average with at least two Heavy Drinking Days (HDDs) in the month prior to screening, desire either reducing or ceasing drinking altogether, have a minimum 6th grade English reading level, present no gross cognitive impairment, nominate a reliable individual aware of their whereabouts for follow ups during the study if applicable; all female participants require birth control/sterilisation methods as well as negative pregnancy tests before entering treatment and"

Answered by AI

Is there still an opportunity to volunteer for this research endeavor?

"It appears that this medical trial is not seeking new participants at present, as indicated on clinicaltrials.gov; the posting was first made available December 1st 2022 and last updated September 29th 2022. However, there are still 364 other studies actively enrolling volunteers."

Answered by AI

Has the Food and Drug Administration sanctioned Ibudilast for public usage?

"Owing to the fact that Ibudilast has only been tested in Phase 2 trials, meaning safety is evidenced but efficacy is not yet proven, our team's assessment of its security was an even 2."

Answered by AI

Who else is applying?

What state do they live in?
New York
What site did they apply to?
University of Pennsylvania Center for Studies of Addiction
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
2
3+

Why did patients apply to this trial?

Tired of alcohol treatment programs. Chantix smoking. ? Alcohol.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Ibudilast for Treating Alcohol Use Disorder
Henry Kranzler 2023. "Ibudilast for Treating Alcohol Use Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05414240.
All > Alcoholism
~33 spots leftby Dec 2027
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