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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05414240
The ClinicalTrials.gov registry entry for NCT05414240 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 374-participant average among 65 other Alcoholism trials with a reported enrollment target (87% lower). The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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