Multimodal Immune and Neuroendocrine Assessment in Drinkers

NCT07220148 | Not Yet Recruiting DMC

• 1 other identifier: STUDY00000843
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alcohol Drinking

Outcome Measures

Primary Outcomes (3)

• Neural cue reactivity to alcohol stimuli (fMRI BOLD response)

  Change in blood-oxygen-level dependent (BOLD) activation to alcohol versus neutral cues in regions of interest (e.g., medial prefrontal cortex, posterior cingulate cortex, striatum) measured using 7 Tesla functional MRI.

  Baseline, 1-year follow-up, 2-year follow-up.

• Cortisol and IL-6 reactivity to alcohol cues

  Change in plasma cortisol and interleukin-6 concentrations (pg/mL) from pre- to post-cue exposure in the laboratory alcohol administration session.

  Baseline, 1-year follow-up, 2-year follow-up.

• Alcohol craving and consumption following cue exposure

  Alcohol craving ratings on the Alcohol Urge Questionnaire (1-7 visual analog scale, high scores mean worse outocme) and total volume of alcohol consumed (mL) during the Alcohol Taste Test following cue exposure.

  Baseline, 1-year follow-up, 2-year follow-up.

Secondary Outcomes (2)

• Real-world craving and drinking behavior (EMA)

  30-day EMA period after each assessment wave (baseline, 1 year, 2 years).

• Composite biomarker index of neurobiological vulnerability

  Baseline, 1-year follow-up, 2-year follow-up.

Study Arms (2)

Binge Drinkers

EXPERIMENTAL

Behavioral Intervention: Laboratory alcohol administration and cue exposure task; completion of EMA and blood sampling at all waves.

Behavioral: Alcohol Cue Reactivity and Laboratory Alcohol Administration Paradigm

Social Drinkers

EXPERIMENTAL

Behavioral Intervention: Identical procedures without the binge-level drinking phenotype; completion of EMA and blood sampling at all waves.

Behavioral: Alcohol Cue Reactivity and Laboratory Alcohol Administration Paradigm

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.

Binge Drinkers; Social Drinkers

Eligibility Criteria

• Age: 21 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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

You may not qualify if:

• All Participants:
• Any psychotic disorder or current psychiatric symptoms requiring specific attention, including active symptoms of psychosis or suicidal/homicidal ideation
• meets criteria for current or past moderate or severe substance use disorder
• women who are pregnant or lactating
• inability to give informed consent
• any contraindications for MRI (e.g., medical devices in the body, claustrophobia, etc)
• current PTSD or acute stress disorder
• other illicit drug use as determined by a urine drug screen

Sponsors & Collaborators

• Auburn University: lead

Study Sites (1)

Auburn University MRI Center

Auburn, Alabama, 36832, United States

Location

MeSH Terms

Conditions

Alcohol Drinking

Interventions

Ethanol; Laboratories

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals; Non-Medical Public and Private Facilities; Health Facilities; Health Care Facilities Workforce and Services

Central Study Contacts

Sara Blaine, PhD

CONTACT

6103041056; skb0058@auburn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 19, 2025
• First Posted: October 23, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2031
• Study Completion (Estimated): December 1, 2031
• Last Updated: October 23, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will become available in 2033 and remain accessible thereafter.

Locations

US (1)