Understanding Alcohol Reward in Social Context
Primary Purpose
Alcohol Drinking, Alcohol Use Disorder, Alcohol Intoxication
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Alcohol
Sponsored by
About this trial
This is an interventional basic science trial for Alcohol Drinking
Eligibility Criteria
Inclusion Criteria:
- Between the ages of 21 and 30
- Currently drinks alcohol
- Able to provide at least 2 same-gender friend referrals
Exclusion Criteria:
- Female participant is pregnant or trying to become pregnant
- Endorsed medical disorder caused by, or made worse by, alcohol
- History of severe alcohol problems
- Use of drugs known to interact with alcohol
Sites / Locations
- University of Illinois at Urbana-ChampaignRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Alcohol Administration
Control Beverage Administration
Arm Description
A moderate dose of alcohol (Target BAC .08%)
Participants consume a non-alcoholic beverage
Outcomes
Primary Outcome Measures
Self-Reported Emotion
Positive and negative emotion will be assessed during the laboratory beverage-administration session via self-report on the "8-item Mood Measure."
Self-Reported Social Reinforcement
Social reinforcement will be assessed using an index of perceived social closeness as well as a modified version of the Perceived Group Reinforcement Scale.
Secondary Outcome Measures
Social Bonding
Social bonding will be assessed during the laboratory beverage-administration session. This will be assessed by examining the synchronization among group members of facial expressions of emotion.
Self-Reported Emotion
Positive and negative emotion will be assessed during the ambulatory assessment period via self-report on the "8-item Mood Measure."
Interpersonal Distance
Physical proximity to other participants during the experiment
Neuro-cognitive social engagement
Electroencephalogram (EEG) hyperscanning methods will be employed to assess task engagement and social attention, including through the examination of event-related potentials (ERPs) during social tasks.
Full Information
NCT ID
NCT03449095
First Posted
November 23, 2017
Last Updated
January 17, 2023
Sponsor
University of Illinois at Urbana-Champaign
1. Study Identification
Unique Protocol Identification Number
NCT03449095
Brief Title
Understanding Alcohol Reward in Social Context
Official Title
Examining the Impact of Stress on the Emotionally Reinforcing Properties of Alcohol in Heavy Social Drinkers: A Multimodal Investigation Integrating Laboratory and Ambulatory Methods
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 4, 2017 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Urbana-Champaign
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
In this study, the investigators examine whether emotional and social reward from alcohol varies depending on the social context of consumption.
Detailed Description
Objective: Although the vast majority of alcohol consumption outside the laboratory occurs in social context, experimental studies of alcohol's emotionally reinforcing effects have overwhelmingly examined individuals drinking in isolation. The current study examines motivationally salient elements of everyday social drinking contexts as moderators of alcohol-related reinforcement. More specifically, the present study examine whether alcohol is more reinforcing within the context of unfamiliar vs. familiar social interaction and, further, whether alcohol is more reinforcing within the context of low vs. high quality social relationships. The current study furthermore examine whether individuals with characteristics that put them at risk for developing an alcohol use disorder (e.g., male gender, impulsive/extraverted personality profile, heavy patterns of consumption, family history of AUD, ...) exhibit heightened emotional reinforcement from alcohol within these social drinking contexts.
The current project represents a test of competing theories of alcohol reinforcement. Alcohol myopia theory-which has heretofore represented the most prominent theory of alcohol's effects-predicts that alcohol's ability to relieve stress depends on the nature (positive or negative) of stimuli in the drinker's immediate environment. Alcohol myopia theory might thus predict that alcohol's rewarding effects will be larger within familiar interactions and within secure relationships. In contrast, the social attributional theory of alcohol reinforcement predicts that alcohol-related reinforcement will be most pronounced within the context of unfamiliar social interactions.
In addition to providing an opportunity to test contextual and individual-level moderators of alcohol reinforcement, the current study represents an opportunity to directly test the replicability of research indicating a pronounced reinforcing effect of alcohol specifically within interactions among unfamiliar individuals (Sayette et al., 2012; Fairbairn et al., 2013).
Study Population: Participants will consist of 640 male and female drinkers, aged 21-30, with no reported history of severe alcohol use disorder. Participants will be sampled such that at least 360 of these participants will classify as heavy drinkers.
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 the company of either familiar or unfamiliar individuals. Of these individuals, a subset will participate in additional tasks post beverage-consumption including a hyperscanning EEG task, while an additional subset will also participate in an ambulatory assessment period over the course of several weeks to examine the interaction of alcohol and social contextual factors in daily life. 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 self-reports of positive and negative mood and perceived social reinforcement. The investigators will also examine facial expressions using the Facial Action Coding System, a comprehensive, anatomically-based system for categorizing facial muscle movement. One aim of the current study is to examine whether differential reinforcement from alcohol in unfamiliar social contexts emerges only with respect to self-reports, or is also observable within facial behaviors. EEG/ERP measures will also be examined for a subset of participants engaged in a hyperscanning task.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking, Alcohol Use Disorder, Alcohol Intoxication, Alcohol; Harmful Use, Alcoholism, Binge Drinking
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
640 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Alcohol Administration
Arm Type
Experimental
Arm Description
A moderate dose of alcohol (Target BAC .08%)
Arm Title
Control Beverage Administration
Arm Type
No Intervention
Arm Description
Participants consume a non-alcoholic beverage
Intervention Type
Drug
Intervention Name(s)
Alcohol
Intervention Description
Alcohol Target BAC .08%
Primary Outcome Measure Information:
Title
Self-Reported Emotion
Description
Positive and negative emotion will be assessed during the laboratory beverage-administration session via self-report on the "8-item Mood Measure."
Time Frame
1 day (laboratory session)
Title
Self-Reported Social Reinforcement
Description
Social reinforcement will be assessed using an index of perceived social closeness as well as a modified version of the Perceived Group Reinforcement Scale.
Time Frame
1 day (laboratory session)
Secondary Outcome Measure Information:
Title
Social Bonding
Description
Social bonding will be assessed during the laboratory beverage-administration session. This will be assessed by examining the synchronization among group members of facial expressions of emotion.
Time Frame
1 day (laboratory session)
Title
Self-Reported Emotion
Description
Positive and negative emotion will be assessed during the ambulatory assessment period via self-report on the "8-item Mood Measure."
Time Frame
2-3 week ambulatory assessment period
Title
Interpersonal Distance
Description
Physical proximity to other participants during the experiment
Time Frame
1 day (laboratory session)
Title
Neuro-cognitive social engagement
Description
Electroencephalogram (EEG) hyperscanning methods will be employed to assess task engagement and social attention, including through the examination of event-related potentials (ERPs) during social tasks.
Time Frame
1 day (laboratory session)
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
May be either male or female, but must be same as gender assigned at birth.
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Between the ages of 21 and 30
Currently drinks alcohol
Able to provide at least 2 same-gender friend referrals
Exclusion Criteria:
Female participant is pregnant or trying to become pregnant
Endorsed medical disorder caused by, or made worse by, alcohol
History of severe alcohol problems
Use of drugs known to interact with alcohol
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Catharine E Fairbairn, Ph.D.
Phone
217 300 5850
Email
cfairbai@illlinois.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Brynne Velia, B.S.
Phone
217 300 5850
Email
bvelia@illinois.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catharine E Fairbairn, Ph.D.
Organizational Affiliation
University of Illinois at Urbana-Champaign
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Illinois at Urbana-Champaign
City
Champaign
State/Province
Illinois
ZIP/Postal Code
61820
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catharine E Fairbairn, Ph.D.
Phone
217-300-5850
Email
uiucalcohollab@gmail.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
2221564
Citation
Steele CM, Josephs RA. Alcohol myopia. Its prized and dangerous effects. Am Psychol. 1990 Aug;45(8):921-33. doi: 10.1037//0003-066x.45.8.921.
Results Reference
background
PubMed Identifier
28287750
Citation
Fairbairn CE. Drinking among strangers: A meta-analysis examining familiarity as a moderator of alcohol's rewarding effects. Psychol Addict Behav. 2017 May;31(3):255-264. doi: 10.1037/adb0000264. Epub 2017 Mar 13.
Results Reference
background
PubMed Identifier
25180806
Citation
Fairbairn CE, Sayette MA. A social-attributional analysis of alcohol response. Psychol Bull. 2014 Sep;140(5):1361-82. doi: 10.1037/a0037563.
Results Reference
background
PubMed Identifier
22760882
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.
Results Reference
background
PubMed Identifier
24016015
Citation
Fairbairn CE, Sayette MA. The effect of alcohol on emotional inertia: a test of alcohol myopia. J Abnorm Psychol. 2013 Aug;122(3):770-81. doi: 10.1037/a0032980.
Results Reference
background
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Understanding Alcohol Reward in Social Context
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