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NCT05414240 · ClinicalTrials.gov registry record · Phase 2
Ibudilast for Treating Alcohol Use Disorder
A Phase 2 study of Alcoholism and Alcohol Use Disorder (AUD), sponsored by University of Pennsylvania.
- Active
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT05414240: Active Phase 2 study of Alcoholism and Alcohol Use Disorder (AUD), sponsored by University of Pennsylvania.
NCT05414240 is a Phase 2 study of Alcoholism and Alcohol Use Disorder (AUD) that is active but no longer recruiting, run by University of Pennsylvania. The registered enrollment target is 50 participants, below the 374-participant average among 65 other Alcoholism trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05414240, a Phase 2 study of Alcoholism and Alcohol Use Disorder (AUD), is active but no longer recruiting, sponsored by University of Pennsylvania.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a research study involving 6 weeks of study medication, Ibudilast or a placebo (an inactive substance) and medical management counseling to reduce or stop drinking. Ibudilast is not approved by the U.S. FDA for clinical use in the United States, but it is has been used for many years in Japan for its anti-inflammatory effects. Its use in the treatment of alcohol dependence is experimental. By reducing inflammation, Ibudilast may help some people reduce or stop drinking. We have obtained an Investigational New Drug Application (IND) approval for this study from the FDA. Ibudilast has been used clinically for 20 years in Asia for treating bronchial asthma and, more recently, for post-stroke dizziness and ocular allergies and has been shown to be safe and well tolerated.
Primary Outcome
Frequency of heavy drinking (defined as 4 or more drinks in a day for women and five or more drinks in a day for men).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Ibudilast
- BEHAVIORAL Medical management
Study Locations (1)
Pennsylvania
- University of Pennsylvania Center for Studies of Addiction - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2023-01-14 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 2 |
What the registry record for NCT05414240 still lists
NCT05414240 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 374-participant average among 65 other Alcoholism trials with a reported enrollment target (87% lower).
The record links to 2 conditions, with Alcoholism appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT05414240 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05414240 about?
NCT05414240 is a clinical study titled "Ibudilast for Treating Alcohol Use Disorder". This is a research study involving 6 weeks of study medication, Ibudilast or a placebo (an inactive substance) and medical management counseling to reduce or stop drinking. Ibudilast is not approved by the U.S. FDA for clinical use in the United States, but it is has been used for many years in Japa...
What is the current status of trial NCT05414240?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2023-01-14. Estimated completion is 2027-12-31.
What conditions does trial NCT05414240 study?
This clinical trial studies the following conditions: Alcoholism, Alcohol Use Disorder (AUD).
What interventions are being tested in trial NCT05414240?
The interventions under investigation include: Placebo (DRUG), Ibudilast (DRUG), Medical management (BEHAVIORAL).
Who is sponsoring clinical trial NCT05414240?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05414240 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Alcoholism
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05414240's enrollment target sits among peer trials
50 52nd of 65 higher than 14 of 65 other Alcoholism trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alcoholism trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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