A Pilot Study on the Effects of Nimodipine on Alcohol Drinking Among Adults Who Are Heavy Alcohol Drinkers
Yale University
Summary
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).
Description
This is an open label trial. Five adults, 21-50 years of age, with Alcohol Use Disorder, who are not looking for treatment for their drinking behaviors, and who consume at least 30-70 standard drinks for men or 25-65 standard drinks for women per week will be recruited. Participants will be screened for eligibility including a full physical exam. All will participate in an alcohol drinking paradigm (ADP) lab session at Yale New Haven Hospital's Hospital Research Unit (HRU). Participants will receive nimodipine 90 mg/dose every six hours during an 18-hour period prior to the ADP session while a…
Eligibility
- Age range
- 21–50 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Ages 21-50 (The lower limit is to avoid offering alcohol to individuals below the drinking age of 21. The upper age is determined by experience recruiting for our prior studies). 2. Ability to read English at 6th grade level or higher. 3. Meet DSM-V criteria for at least moderate AUD. 4. Average weekly alcohol consumption of 30-70 standard drinks for men and 20-65 drinks for women. The lower limits are consistent with the lower sex-specific cut-offs defining high-risk drinking based on World Health Organization Risk Levels (WHO, 2000); the upper limits are designed to a…
Interventions
- DrugNimodipine
Nimodipine 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.
Location
- Yale University School of Medicine (Connecticut Mental Health Center)New Haven, Connecticut