Effects of Nimodipine on Alcohol Drinking

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age21-50
SponsorYale University

About this trial

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.

Eligibility criteria

Qualifiers

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).

Ability to read English at 6th grade level or higher.

Meet DSM-V criteria for at least moderate AUD.

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 avoid recruiting participants whose drinking is likely to exceed the number of drinks available in the alcohol drinking paradigm (ADP).

Disqualifiers

Individuals who are seeking alcohol treatment or have been in alcohol treatment within the past 6 months.

Meet current DSM-V criteria for substance use disorder, except for tobacco use disorder or mild cannabis use disorder.

Positive urine drug screens at more than 1 baseline appointment for opiates, cocaine, benzodiazepines, and barbiturates.

Psychotic or other severe psychiatric disorders as determined by clinical evaluation.

Trial design

Treatments tested in this trial

  • Nimodipine
  • Placebo

Treatment groups

40 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Yale University

Lead sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator