Ethanol for Alcohol-Related Behaviors in Healthy Subjects

Overseen by Vijay A Ramchandani, Ph.D.

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

No Placebo Group

Trial Summary

What is the purpose of this trial?

Background: Alcohol use disorder (AUD) can damage people s health, work, and family. Researchers want to know more about why some people are more vulnerable to AUD than others. The ZIP8 gene may be linked to an increased risk of AUD. Researchers want to find out how different forms of the ZIP8 gene affect how healthy people drink alcohol and how alcohol affects their brain. Objective: To study how genes may affect how people drink alcohol and how it affects their brain. Eligibility: Healthy people aged 21 to 60 years. They must not smoke, and they must have no history of AUD. They must have European ancestry and be enrolled in Natural History Protocol (14-AA-0181). Design: Participants will have 2 study visits. At the first visit, participants will be given alcohol; it will be infused through a tube attached to a needle inserted into a vein. They may self-administer each dose by pressing a button. Over time, they will have to press the button an increasing number of times to receive more alcohol. The infusion period will last 2.5 hours. Participants will have blood samples taken and breath measurments, and they will do computer tasks and complete questionnaires during and after the infusion. After the infusion, they will remain in the clinic until their breath alcohol levels drop to a safe level. At the second visit, participants will have an imaging scan of their brain. They will do tasks and play games on a computer screen during the scan. Some participants may have an extra visit for screening. A mid-study visit may also be needed if more than 6 months pass between the 2 study visits....

Research Team

Vijay A Ramchandani, Ph.D.

Principal Investigator

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Eligibility Criteria

This trial is for healthy individuals aged 21 to 60 with European ancestry who don't smoke and have no history of alcohol use disorder. They must be part of another study (14-AA-0181) and cannot have any conditions that exclude them from safely participating.

Inclusion Criteria

I am between 21 and 60 years old.

Non-smokers with no history of smoking in the past year and not a daily smoker for more than 1 month in their lifetime

Participants of European ancestry

Exclusion Criteria

Current history of psychiatric disorders, including depressive disorder, bipolar disorder, or anxiety disorders

Lifetime history of psychotic disorders, obsessive compulsive disorder (OCD), posttraumatic stress disorder (PTSD), or eating disorder

Current or lifetime diagnosis of alcohol or substance use disorder

Treatment Details

Interventions

• ZIP8 (Ion Transporter)

Trial Overview The study investigates how different forms of the ZIP8 gene influence drinking behavior and brain response to alcohol in healthy people. Participants will receive alcohol intravenously, perform computer tasks, answer questionnaires, and undergo a brain imaging scan.

Participant Groups

Group I: IV Ethanol Experimental Treatment 1 Intervention

IV Ethanol

Who Is Running the Clinical Trial?

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Lead Sponsor

Trials

865

Recruited

1,091,000+

Dr. George F. Koob

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Chief Executive Officer since 2014

PhD in Neurobiology from the Scripps Research Institute

Dr. Patricia Powell

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Chief Medical Officer since 2015

MD from an accredited institution