Pilot Study: Effects of Nimodipine on Alcohol Drinking
Part of paid clinical trials in New Haven, Connecticut.
- Sponsor
- Yale University
- Study ID
- NCT06900998
- Phase
- PHASE2
- Status
- Not Yet Recruiting
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Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 21 Years - 50 Years
- Healthy Volunteers
- Not accepted
Interventions
- Nimodipine — DRUGNimodipine will be administered orally beginning on the evening prior to the study lab session. 90mg doses will be administered at 6:00pm, 12:00am, 6:00am, and 12:00pm.
Study Details
This is an open label trial aiming to recruit 5 non-treatment seeking adults with Alcohol Use Disorder. All will participate in an alcohol drinking paradigm (ADP) lab session at the Hospital Research Unit (HRU) at Yale-New Haven Hospital (YNHH). Participants will stay overnight and receive nimodipine 90 mg/dose every six hours during an 18-hour period prior to the ADP to allow for the limited central nervous system bioavailability of this drug. Electroencephalogram (EEG) data will be collected before the first dose and after the last dose of nimodipine. Adverse events will be closely monitored during this period. During the ADP session participants will receive a priming dose of alcohol followed by a one-hour monitoring period. This will be followed by three one-hour self-administration periods; during each hour, participants will be able to choose between drinking up to four drinks or receive the monetary equivalents of these drinks (total of 12 drinks over three hours).
Key Dates
- Start date
- Sep 1, 2026
- Status verified
- Oct 2025
- Primary completion
- Jun 30, 2032
- Completion
- Jun 30, 2032
Study Design
- Enrollment
- 5 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- OTHER
Arms
- Experimental: NimodipineAll participants will be assigned to this arm and will receive study drug (nimodipine), open label.
Primary Outcome Measure
Number of drinks consumed [ Time Frame: Lab Session 1 (Day 1) ]
Central Contacts
- Thomas Liss2034447545
- Nicholas Franco2039745759
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Yale University School of Medicine (Connecticut Mental Health Center) | New Haven | Connecticut | 06519 | Suchitra Krishnan-Sarin, PhD (PRINCIPAL_INVESTIGATOR) |
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