Multimodal Immune and Neuroendocrine Assessment in Drinkers

Part of paid clinical trials in Auburn, Alabama.

Sponsor
Auburn University
Study ID
NCT07220148
Status
Not Yet Recruiting

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Conditions

  • Alcohol Drinking

Eligibility Criteria

Sex
ALL
Age
21 Years - 25 Years
Healthy Volunteers
Accepted

Interventions

  • Alcohol Cue Reactivity and Laboratory Alcohol Administration Paradigm — BEHAVIORAL
    Mechanistic evaluation of neural, neuroendocrine, and immune biomarkers underlying alcohol cue reactivity and drinking behavior.

Study Details

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.

Key Dates

Start date
Apr 30, 2026
Status verified
Oct 2025
Primary completion
Dec 31, 2031
Completion
Dec 31, 2031

Study Design

Enrollment
234 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Binge Drinkers
    Behavioral Intervention: Laboratory alcohol administration and cue exposure task; completion of EMA and blood sampling at all waves.
  • Experimental: Social Drinkers
    Behavioral Intervention: Identical procedures without the binge-level drinking phenotype; completion of EMA and blood sampling at all waves.

Primary Outcome Measure

Neural cue reactivity to alcohol stimuli (fMRI BOLD response) [ Time Frame: Baseline, 1-year follow-up, 2-year follow-up. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Auburn University MRI CenterAuburnAlabama36832
Tom Denney, PhD

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