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Ibudilast for Treating Alcohol Use Disorder
NCT05414240Phase 2
Key facts
- Status
- Active, not recruiting
- Start
- Jan 2023
- Primary completion
- Dec 2026
- Countries
- 1
- Sponsor
- University of Pennsylvania
- Modality
- Small Molecules
- Drugs
- ibudilast
- Conditions
- alcohol use disorder (AUD)
01
Overview
Phase 2, randomised, double-blind trial in alcohol use disorder (AUD) comparing Ibudilast with Inactive placebo (2 arms). Primary endpoint: Change in the frequency of heavy drinking at 6 weeks. Started Jan 2023; status: active, not recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Ibudilast
Ibudilast 20 mg twice daily for 2 days, then 50 mg twice daily through week 6, tapering to 20 mg twice daily for the last 3 days + Medical management.
Inactive placebo
Placebo twice daily for 6 weeks + Medical management.
03
Who it enrols
Patients with DSM-5 Alcohol Use Disorder who are physically healthy, consume heavy amounts of alcohol (>24 drinks/week for men, >18 for women), and want to reduce or stop drinking. Excludes those with serious psychiatric illnesses, other drug dependencies, or significant physical diseases.
04
Endpoints
Primary
Change in the frequency of heavy drinking
Secondary
Change in the number of abstinent days
Change in the number of heavy drinking days
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