NCT07125534

Brief Summary

The study investigates the effects of alcohol consumption on social and individual behaviors using a within-subject design. Participants, aged 21-30, will attend two laboratory sessions approximately one week apart, participating as part of a dyad (pair). During one session, they will consume an alcoholic beverage, while in the other, they will receive a control beverage, with the order of conditions randomized. This design facilitates direct within-participant comparisons of behaviors and neural activity in intoxicated versus sober states. To achieve these aims, the study employs EEG technology to explore intra-brain and inter-brain dynamics during social interactions. Additionally, validated self-report questionnaires will capture data on mood, social bonding, and other psychological variables. The findings are expected to enhance understanding of alcohol's role in social reward processes and contribute to developing evidence-based prevention and intervention strategies for alcohol use disorder.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
24mo left

Started Aug 2025

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress27%
Aug 2025May 2028

First Submitted

Initial submission to the registry

August 9, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

August 9, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 15, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Last Updated

August 29, 2025

Status Verified

August 1, 2025

Enrollment Period

1.4 years

First QC Date

August 9, 2025

Last Update Submit

August 22, 2025

Conditions

Outcome Measures

Primary Outcomes (5)

  • Inter-brain entrainment

    Synchronization metrics (e.g., inter-subject PLV, inter-subject correlation) between paired participants, assessed separately in sober and intoxicated conditions

    During active laboratory beverage manipulation exposure (during or immediately after beverage administration, at which time participants in the alcohol condition will register a positive BAC)

  • Intra-brain entrainment

    The comparison of EEG signal synchronization within the same participant across the alcohol and non-alcohol conditions, reflecting intra-brain activity changes due to alcohol consumption during the hyperscanning task.

    During active laboratory beverage manipulation exposure (during or immediately after beverage administration, at which time participants in the alcohol condition will register a positive BAC)

  • Event-Related Potentials (ERP)

    Feedback-Related Negativity (FRN), measured both for the operating ("player") and observing ("observer") participant, with comparisons across sobriety conditions

    During active laboratory beverage manipulation exposure (during or immediately after beverage administration, at which time participants in the alcohol condition will register a positive BAC)

  • Ambulatory Drinking

    Drinking behavior assessed outside the laboratory using ambulatory assessment

    14 days

  • Longitudinal Drinking Problems

    Drinking assessed at longitudinal follow-up

    Up to 24 months post-baseline

Study Arms (2)

Alcohol beverage administration

EXPERIMENTAL
Drug: Alcohol beverage

Control condition - non alcoholic beverage

OTHER
Other: Control - non alcoholic beverage

Interventions

This intervention involves the administration of an alcohol beverage (vodka mixed with juice or soda) in a controlled laboratory setting, targeting a blood alcohol concentration (BAC) of 0.08%. The alcohol is consumed over a 36-minute period in three equal parts.

Alcohol beverage administration

This intervention involves the administration of a non-alcoholic control beverage in a controlled laboratory setting. The beverage is matched in volume and palatability to the alcohol condition but co

Control condition - non alcoholic beverage

Eligibility Criteria

Age21 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Between the ages of 21 and 30
  • Regularly consumes alcohol

You may not qualify if:

  • History of adverse reaction to the amount of beverage employed in the study
  • Have a history of major problems associated with alcohol
  • Take medications that could adversely interact with alcohol
  • Have medical conditions that contraindicate alcohol administration
  • Individuals with a history of skull fractures or who indicate discomfort with EEG procedures used
  • Female participant is pregnant or trying to become pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Illinois at Urbana Champaign

Champaign, Illinois, 61820, United States

NOT YET RECRUITING

University of Illinois Urbana-Champaign

Champaign, Illinois, 61820, United States

RECRUITING

MeSH Terms

Conditions

Alcohol DrinkingAlcoholismAlcoholic IntoxicationBinge Drinking

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Drinking BehaviorBehaviorAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Central Study Contacts

Catharine E Fairbairn, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D.

Study Record Dates

First Submitted

August 9, 2025

First Posted

August 15, 2025

Study Start

August 9, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

May 1, 2028

Last Updated

August 29, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

Data is being shared on the National Institute of Mental Health Data Archive

Locations