Multimodal Immune and Neuroendocrine Assessment in Drinkers

NCT ID: NCT07220148

Last Updated: 2025-10-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 234 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-04-30
• Study Completion Date: 2031-12-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Binge Drinkers

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

Group Type: EXPERIMENTAL

Alcohol Cue Reactivity and Laboratory Alcohol Administration Paradigm

Intervention Type: BEHAVIORAL

Mechanistic evaluation of neural, neuroendocrine, and immune biomarkers underlying alcohol cue reactivity and drinking behavior.

Social Drinkers

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

Group Type: EXPERIMENTAL

Alcohol Cue Reactivity and Laboratory Alcohol Administration Paradigm

Intervention Type: BEHAVIORAL

Mechanistic evaluation of neural, neuroendocrine, and immune biomarkers underlying alcohol cue reactivity and drinking behavior.

Interventions

Alcohol Cue Reactivity and Laboratory Alcohol Administration Paradigm

Mechanistic evaluation of neural, neuroendocrine, and immune biomarkers underlying alcohol cue reactivity and drinking behavior.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

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 Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Auburn University

OTHER

Sponsor Role: lead

Responsible Party

Sara K Blaine

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Auburn University MRI Center

Auburn, Alabama, United States

Countries

United States

Central Contacts

Sara Blaine, PhD

Role: CONTACT

skb0058@auburn.edu

6103041056

Facility Contacts

Tom Denney, PhD

Role: primary

dennets@auburn.edu

Other Identifiers

STUDY00000843

Identifier Type: -

Identifier Source: org_study_id