- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07125534
- Original Trial
Alcohol and the Social Brain: An Alcohol-Administration Hyperscanning Study Employing a Within-Subject Design
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Objective:
Alcohol's ability to enhance social bonding and modulate mood in social contexts has been identified as a key factor contributing to its reinforcing properties and risk for Alcohol Use Disorder (AUD). While prior research has demonstrated alcohol's role in enhancing social interactions, laboratory studies often fail to replicate the real-world context in which most alcohol consumption occurs-social settings with familiar companions. This discrepancy limits our understanding of the mechanisms through which alcohol exerts its effects in social contexts.
This study is the first to employ EEG hyperscanning methods to investigate the inter- and intra-brain mechanisms underlying alcohol's social rewards within dyadic interactions. Specifically, the study aims to characterize how alcohol modulates social bonding, emotional regulation, and neural synchrony during social interactions, and to identify the cognitive and affective processes driving alcohol's reinforcing properties. The findings are expected to deepen understanding of the role of alcohol in social dynamics and inform interventions for AUD.
Study Population:
The study will recruit 200 participants, aged 21-30, who self-identify as regular social drinkers and with no reported history of severe alcohol use disorder.
Design:
This within-subject laboratory study involves two experimental sessions spaced approximately one week apart. Each session includes participants interacting in dyads with a stranger, where they will consume either a moderate dose of alcohol (target BAC ~0.08%) or a non-alcoholic control beverage, with the order randomized between sessions. Participants will engage in structured and unstructured tasks during each session, allowing for the evaluation of behavioral, emotional, and neural outcomes in both intoxicated and sober states.
- EEG Hyperscanning: Neural activity will be recorded simultaneously from both members of the dyad using EEG hyperscanning technology. This allows for the investigation of intra-brain processes (e.g., cognitive and emotional regulation) and inter-brain synchrony (e.g., neural alignment during social interactions).
- Tasks and Measures: Participants will complete tasks designed to assess social bonding, emotional regulation, and cognitive processing. Tasks include structured paradigms (e.g., music perception tasks and flanker task) and naturalistic social interactions. These are complemented by self-report measures assessing mood, social closeness, and perceptions of the interaction.
- Randomization and Counterbalancing: The order of alcohol versus control sessions will be randomized across participants to control for carryover effects.
Outcome Measures:
Neurophysiological Outcomes:
Intra and Inter Brain Coupling (IBC):
- Intra brain synchrony (within-subject): Coherence or phase-locking between brain regions within the same participant, compared across sober versus intoxicated states.
- Inter brain synchrony (between-subject): Synchronization metrics (e.g., inter subject PLV, inter subject correlation) between paired participants, assessed separately in sober and intoxicated conditions
Event Related Potentials (ERP):
• Amplitudes and latencies of task-related ERP components, specifically Feedback Related Negativity (FRN), measured both for the operating ("player") and observing ("observer") participant, with comparisons across sobriety conditions
Behavioral and Psychological Outcomes:
Self-reported mood and social bonding assessed pre- and post-interaction using validated measures such as the Inclusion of Other in Self Scale and the Biphasic Alcohol Effects Scale.
Observational coding of nonverbal behaviors (e.g., facial expressions, body language) during dyadic interactions.
- Drinking Behavior:
Longitudinal self-reports of drinking patterns and alcohol-related outcomes.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Catharine E Fairbairn, Ph.D.
- Phone Number: 217 300 5850
- Email: cfairbai@illlinois.edu
Study Locations
-
-
Illinois
-
Champaign, Illinois, United States, 61820
- Recruiting
- University of Illinois Urbana-Champaign
-
Principal Investigator:
- Catharine Fairbairn, Ph.D.
-
Contact:
- Catharine Fairbairn, Ph.D.
- Phone Number: 217 300 5850
- Email: cfairbai@illlinois.edu
-
Champaign, Illinois, United States, 61820
- Not yet recruiting
- University of Illinois at Urbana Champaign
-
Contact:
- Catharine E Fairbairn, Ph.D.
- Phone Number: 2173005850
- Email: cfairbai@illlinois.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Between the ages of 21 and 30
- Regularly consumes alcohol
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Alcohol beverage administration
|
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.
|
|
Other: Control condition - non alcoholic beverage
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ambulatory Drinking
Time Frame: 14 days
|
Drinking behavior assessed outside the laboratory using ambulatory assessment
|
14 days
|
|
Longitudinal Drinking Problems
Time Frame: Up to 24 months post-baseline
|
Drinking assessed at longitudinal follow-up
|
Up to 24 months post-baseline
|
|
Inter-brain entrainment
Time Frame: 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)
|
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
Time Frame: 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)
|
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)
Time Frame: 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)
|
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)
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2R01AA025969-01 (U.S. NIH Grant/Contract)
- 2R01AA025969 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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