Alcohol DrinkingNCT07125534
Alcohol and the Social Brain: An Alcohol-Administration Hyperscanning Study Employing a Within-Subject Design
A study testing Alcohol beverage in people with Alcohol Drinking and Alcohol Use Disorder (AUD), run by University of Illinois at Urbana-Champaign at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Drinking, Alcohol Use Disorder (AUD), Alcohol Intoxication
- What is being tested?
- Alcohol beverage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Aug 2025to May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between the ages of 21 and 30
- Regularly consumes alcohol
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
University of Illinois at Urbana Champaign
Champaign, Illinois, 61820
Catharine E Fairbairn, Ph.D., 2173005850, cfairbai@illlinois.edu
- Recruiting
University of Illinois Urbana-Champaign
Champaign, Illinois, 61820
Catharine Fairbairn, Ph.D., 217 300 5850, cfairbai@illlinois.edu
Catharine Fairbairn, Ph.D.
About this study
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.
Read the 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.
- Conditions
- Alcohol Drinking, Alcohol Use Disorder (AUD), Alcohol Intoxication, Alcohol; Harmful Use, Alcoholism, Binge Drinking
- Being tested
- Alcohol beverage, Control - non alcoholic beverage
- Medical subject headings
- Alcohol Drinking, Alcoholism, Alcoholic Intoxication, Binge Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcohol beverageDrug
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.
Control - non alcoholic beverageOther
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
| Study group | Role | What they receive |
|---|---|---|
| Alcohol beverage administration | Experimental | Not described Receives: Drug: Alcohol beverage |
| Control condition - non alcoholic beverage | Other | Not described Receives: Other: Control - non alcoholic beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inter-brain entrainment
Synchronization metrics (e.g., inter-subject PLV, inter-subject correlation) between paired participants, assessed separately in sober and intoxicated conditions
Measured: 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.
Measured: 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
Measured: 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
Measured: 14 days
Longitudinal Drinking Problems
Drinking assessed at longitudinal follow-up
Measured: Up to 24 months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start9 Aug 2025
- Primary completionJan 2027 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Catharine Fairbairn, University of Illinois at Urbana-Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07125534
- Sponsor's protocol ID
- 2R01AA025969-01
- Status last verified
- Aug 2025
- First submitted
- 9 Aug 2025
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data is being shared on the National Institute of Mental Health Data Archive
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alcohol and the Social Brain: An Alcohol-Administration Hyperscanning Study Employing a Within-Subject Design
- ClinicalTrials.gov ID
- NCT07125534
- Acronym / sponsor ID
- 2R01AA025969-01
- Conditions
- Alcohol Drinking, Alcohol Use Disorder (AUD), Alcohol Intoxication, Alcohol; Harmful Use, Alcoholism, Binge Drinking
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Study start
- 9 Aug 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 15 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alcohol beverage administration | Experimental | Drug: Alcohol beverage |
| Control condition - non alcoholic beverage | Other | Other: Control - non alcoholic beverage |
Who may qualify
- Ages
- 21 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Between the ages of 21 and 30
- Regularly consumes alcohol
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alcohol beverageThis 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. | Drug | Alcohol beverage administration |
| Control - non alcoholic beverageThis 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 | Other | Control condition - non alcoholic beverage |
Primary outcome
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
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.
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
Ambulatory Drinking
Time frame: 14 days
Drinking behavior assessed outside the laboratory using ambulatory assessment
Longitudinal Drinking Problems
Time frame: Up to 24 months post-baseline
Drinking assessed at longitudinal follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Individual participant dataSharing planned: Yes. Data is being shared on the National Institute of Mental Health Data Archive
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alcohol beverage in people with Alcohol Drinking and Alcohol Use Disorder (AUD), run by University of Illinois at Urbana-Champaign at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Catharine E Fairbairn, Ph.D. (217 300 5850, cfairbai@illlinois.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2025.