Phase 2a dose-response study of a medication for alcohol use disorder in women and men
Official title: PROJECT 1: Phase 2a dose-response study of apremilast in females and males with alcohol use disorder
Funded at Yale University · NIH-11416768 · Data updated 2026-11-12
A phase 2a study at Yale will test how a medication called apremilast works at different doses for adults with alcohol use disorder, with attention to differences between women and men.
Quick facts
| Grant type | NIH-funded research |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Yale University NIH-funded |
| Lab location | 1 site (New Haven, United States) |
| Project start | March 10, 2020 |
| Project end | August 31, 2030 |
| Funding year | 2026 |
| Award (this year) | $250,001 |
| NIH project number | 5U54AA027989-07 |
| Project ID | NIH-11416768 on NIH RePORTER |
Who could benefit from this research
✓Could help
Adults with alcohol use disorder who may benefit from a neuroimmune-targeted treatment and can participate in a dose-response study.
✕Less likely to help
Individuals without alcohol use disorder or those unable to participate in a medication trial may not benefit.
What this research studies
This trial looks at how varying doses of apremilast affect people with alcohol use disorder, with separate analyses for women and men. Researchers will build on prior findings about sex differences in drinking behavior and stress-related triggers, focusing on brain immune pathways as a treatment target. The study will explore how the drug influences neuroimmune function and stress-related experiences that can drive drinking. If successful, results could guide more effective, sex-tailored treatments for reducing alcohol use and improving mood-related symptoms. Participants will be recruited through Yale University and associated sites, with careful monitoring for adverse effects and overall well-being.
Why it matters
Potential benefit: Participants may experience reduced alcohol cravings and drinking, along with improved stress regulation and mood.
How similar studies have gone: Previous work shows sex differences in AUD and potential efficacy of PDE4-targeted treatments in reducing drinking.
Where this research is happening
-
Yale University
New Haven, United States Active
Researchers
- Principal investigator: Mckee, Sherry Ann — Yale University
- Study coordinator: Mckee, Sherry Ann
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About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.