Multimodal Immune and Neuroendocrine Assessment in Drinkers (NCT07220148) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Multimodal Immune and Neuroendocrine Assessment in Drinkers
United States234 participantsStarted 2026-04
Plain-language summary
The goal of this clinical trial is to better understand how blood flow in the brain, levels of the hormone, cortisol, and levels of an immune factor, interleukin-6, change in response to pictures of alcohol versus water pictures of water in healthy people who regularly consume alcohol. Researchers will learn about how the brain processes our environment and how it relates to people's drinking behaviors. This information is important because it may allow us to develop new treatments for Alcohol Use Disorders.
Participants will be asked to fill out psychological questionnaires at the first appointment. Then, they will do MRI scans with blood draws at visits 2-6. After each MRI scan, participants will undergo the Alcohol Taste Test, which involves drinking beer.
There will be a total of 3 visits at baseline, 2 visits one year later, and 2 visits one year after that. Each visit will last 2 hours. Each year, participants will do 21 days of surveys on a smart phone (4 surveys a day; each survey takes less than 2 minutes). The total time commitment for the entire study will be 23 hours.
Who can participate
Age range
21 Years – 25 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
In this study, researchers will recruit 234 individuals who report binge use of alcohol or who consume alcohol moderately with no episodes of binge drinking. All participants will be recruited from the community primarily through advertisements in local newspapers, online venues like craigslist, flyers, and list-serve emails, as well as through radio and other media advertisements.
Inclusion Criteria
All Participants:
* Male and Females between the ages of 21-25
* able to read and write in English and complete study evaluations
* able to provide negative breathalyzer and negative toxicology screenings for substances at all study appointments
* able to provide written and verbal consent.
* Must be a beer drinker (not exclusively), to ensure subjects are not averse to the taste of beverages presented in the ATT
* BMI of 18-35
Binge Drinkers:
• At least twice per month binge drinking and weekly alcohol use of at least 8 standard drinks/week females or 15 or more drinks for males for the past year, with binge drinking defined as drinking enough alcohol that brings blood alcohol concentration to 0.08 percent or higher in about 2 hours, which is typically equivalent to consuming 5 or more drinks for males, or 4 or more drinks for females.
Social Drinkers:
• at least weekly alcohol use for the past 6 months not to exceed 7 standard drinks/wk for women and 14 standard drinks/week for males, with no episodes of binge drinking in the past year
Exclusion Cri…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Neural cue reactivity to alcohol stimuli (fMRI BOLD response)