Clinical trial NCT06687525: Alcohol and the Social Brain: an Alcohol-Administration Hyperscanning Study
Official title: Alcohol and the Social Brain: an Alcohol-Administration Hyperscanning Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Alcohol Drinking
Alcohol Use Disorder
Alcohol Intoxication
Alcohol; Harmful Use
Alcoholism
Binge Drinking
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
First posted: 2024-11-13
Enrollment: 240
Sex: ALL
Minimum age (years): 21
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy regular drinkers aged 21-30

Brief summary: In this study, the investigators aim to capture inter- and intra-brain mechanisms underlying alcohol reward in novel social context.

Detailed description: Objective: Alcohol's ability to boost mood in the face of stress is perhaps its most notoriously addictive property, long held by researchers to be of critical importance for understanding alcohol use disorder (AUD) etiology. Yet, while most real-world alcohol consumption occurs in social settings, in the context of laboratory studies, participants have almost always consumed alcohol alone. The discrepancy between real-world and laboratory contexts emerges as particularly stark in the neuroimaging literature, where no alcohol-administration study to date has incorporated in-vivo social context. In this first alcohol-administration study to leverage EEG hyperscanning methods, the investigators aim to capture inter- and intra-brain mechanisms underlying alcohol reward in novel social context.

Specifically, this study aims to characterize the mechanisms driving social reward from alcohol in the context of stress and elucidate the role of social processes and novel social context in driving problem drinking.

Study Population: Participants will consist of 240 regular drinkers, aged 21-30, with no reported history of severe alcohol use disorder.

Design: In the laboratory arm of the study, individuals will be randomly assigned to consume either a moderate dose of alcohol or a control beverage in stranger dyads. Participants will engage in both structured and unstructured tasks aimed at assessing social engagement and threat sensitivity. EEG and ERP data will be collected from both participants simultaneously. In the ambulatory study arm, participants will wear transdermal sensors to assess BAC and will further provide information about their mood and their social contexts in response to random prompts.

Outcome Measures: Primary outcome measures include EEG measures of inter-brain entrainment as well as ERP metrics derived from task contexts (both players and observers). Additional outcomes include measures of positive mood, negative mood, and social bonding. Finally, drinking behaviors will be assessed via transdermal ambulatory alcohol sensors and longitudinal self-reports of drinking.

Eligibility criteria: 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

Primary outcomes:
measure: Inter-brain entrainment
timeFrame: 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)
measure: Feedback-related negativity
timeFrame: 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)
measure: Ambulatory Drinking
timeFrame: 14 days
measure: Longitudinal Drinking Problems
timeFrame: Up to 24 months post-baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Champaign
country: United States
facility: University of Illinois at Urbana-Champaign
state: Illinois
Study officials:
affiliation: University of Illinois at Urbana-Champaign
name: Catharine E Fairbairn, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sayette MA, Creswell KG, Dimoff JD, Fairbairn CE, Cohn JF, Heckman BW, Kirchner TR, Levine JM, Moreland RL. Alcohol and group formation: a multimodal investigation of the effects of alcohol on emotion and social bonding. Psychol Sci. 2012 Aug 1;23(8):869-78. doi: 10.1177/0956797611435134. Epub 2012 Jul 3.
citation: Fairbairn CE, Sayette MA. A social-attributional analysis of alcohol response. Psychol Bull. 2014 Sep;140(5):1361-82. doi: 10.1037/a0037563.
citation: Fairbairn CE, Kang D, Federmeier KD. Alcohol and Neural Dynamics: A Meta-analysis of Acute Alcohol Effects on Event-Related Brain Potentials. Biol Psychiatry. 2021 May 15;89(10):990-1000. doi: 10.1016/j.biopsych.2020.11.024. Epub 2020 Dec 11.