- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06687525
Alcohol and the Social Brain: An Alcohol-Administration Hyperscanning Study
Study Overview
Status
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Illinois
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Champaign, Illinois, United States, 61820
- University of Illinois at Urbana-Champaign
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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)
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The association between dyad-members EEG signals during the hyperscanning task
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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)
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Feedback-related negativity
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)
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An ERP component calculated from a time-estimation task
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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)
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Ambulatory Drinking
Time Frame: 14 days
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Drinking behavior assessed outside the laboratory using ambulatory assessment
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14 days
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Longitudinal Drinking Problems
Time Frame: Up to 24 months post-baseline
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Drinking assessed at longitudinal follow-up
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Up to 24 months post-baseline
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Collaborators and Investigators
Investigators
- Principal Investigator: Catharine E Fairbairn, Ph.D., University of Illinois at Urbana-Champaign
Publications and helpful links
General Publications
- Fairbairn CE, Sayette MA. A social-attributional analysis of alcohol response. Psychol Bull. 2014 Sep;140(5):1361-82. doi: 10.1037/a0037563.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
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 (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.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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