drugset / Trial / NCT05414240

Ibudilast for Treating Alcohol Use Disorder

NCT05414240

Phase 2 Active not recruiting 50 enrolled University of Pennsylvania
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2023-01-14
Primary completion
2026-12-31
Completion
2027-12-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ibudilast Small molecule 50 mg

Indications