Ethanol for Alcohol-Related Behaviors in Healthy Subjects
What You Need to Know Before You Apply
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....
Will I have to stop taking my current medications?
Yes, you may need to stop taking certain medications. The trial excludes participants using medications that interact with alcohol or affect alcohol metabolism, such as some heart, diabetes, and pain medications. You must refrain from these medications for a specified period before the study.
Is ethanol safe for human use in clinical trials?
How does ethanol differ from other treatments for alcohol-related behaviors?
Ethanol is unique because it is the substance being studied for its effects on alcohol-related behaviors, rather than a medication designed to treat alcohol use disorder. Unlike other treatments that aim to reduce alcohol consumption or cravings, this study focuses on understanding ethanol's role in reinforcing drinking behaviors and its interactions with neurotransmitter systems.26789
What data supports the effectiveness of the drug ZIP8 for alcohol-related behaviors?
Who Is on the Research Team?
Vijay A Ramchandani, Ph.D.
Principal Investigator
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Alcohol Infusion and Self-Administration
Participants receive alcohol infusion and may self-administer doses by pressing a button during a 2.5-hour session. Blood samples and breath measurements are taken, and participants complete computer tasks and questionnaires.
Imaging and Cognitive Tasks
Participants undergo an imaging scan of their brain and perform tasks and games on a computer screen during the scan.
Follow-up
Participants are monitored for safety and effectiveness after the main study visits.
What Are the Treatments Tested in This Trial?
Interventions
- ZIP8
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Lead Sponsor