Effects of Nimodipine on Alcohol Drinking

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT07681869
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 — DRUG
    Nimodipine 90mg/dose or matching placebo will be administered every 6 hours for the duration of 18 hours (approx 6pm, 12am, 6am, 12pm). In total, participants will receive a total of 4 doses totaling to 360mg.
  • Placebo — DRUG
    Matching placebo will be administered on the same schedule as Nimodipine, every 6 hours for the duration of 18 hours (approx 6pm, 12am, 6am, 12pm).

Study Details

This is a randomized placebo-controlled trial (RCT). Participants will be non-treatment seeking adults, 21-50 years of age, with Alcohol Use Disorders. All will participate in two alcohol drinking paradigm (ADP) sessions separated by at least 3 days at The Clinical Neuroscience Research Unit (CNRU). Participants will stay overnight and receive nimodipine (90 mg/dose) or placebo every six hours during an 18-hour period prior to each ADP. MEG and/or EEG data will be collected before the first dose and after the third dose of nimodipine (NIM) or placebo (PLA). Adverse events will be closely monitored during this period. During the ADP 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 they will be able to choose between four drinks or monetary equivalents of these drinks (total of 12 drinks over three hours). ADP outcomes will include number of drinks consumed, alcohol craving, mood changes and alcohol effects, physiological measures (heart rate, blood pressure), as well as breath alcohol levels. Investigators anticipate having to recruit up to 40 participants to achieve 20 completers.

Key Dates

Start date
Sep 1, 2026
Status verified
Mar 2026
Primary completion
Jun 30, 2032
Completion
Jun 30, 2032

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Experimental: Nimodipine 1st / Placebo 2nd
    Participants randomized to the Nimodipine 1st Arm will be administered Nimodipine prior to their 1st ADP session. Then after a washout period, participants will take a matching placebo prior to the 2nd lab session.
  • Experimental: Placebo 1st / Nimodipine 2nd
    Participants randomized to the Placebo1st Arm will be administered matching placebo prior to their 1st ADP session. Then after a washout period, participants will be administered Nimodipine prior to the 2nd lab session.

Primary Outcome Measure

Number of drinks consumed [ Time Frame: ADP Lab Session 1 (Day 1) and ADP Lab Session 2 (3-5 days later) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Yale University School of Medicine (Connecticut Mental Health Center)New HavenConnecticut06519-

Find similar trials in New Haven, CT

By condition
Substance use disorder
By specialty
Behavioral healthAddiction medicine
By research site
Yale University School of Medicine (Connecticut Mental Health Center)· New Haven, CT

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