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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03449095
Other study ID # R01AA025969
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 4, 2017
Est. completion date July 5, 2023

Study information

Verified date January 2023
Source University of Illinois at Urbana-Champaign
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In this study, the investigators examine whether emotional and social reward from alcohol varies depending on the social context of consumption.


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.


Recruitment information / eligibility

Status Completed
Enrollment 640
Est. completion date July 5, 2023
Est. primary completion date July 5, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 30 Years
Eligibility 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

Study Design


Intervention

Drug:
Alcohol
Alcohol Target BAC .08%

Locations

Country Name City State
United States University of Illinois at Urbana-Champaign Champaign Illinois

Sponsors (1)

Lead Sponsor Collaborator
University of Illinois at Urbana-Champaign

Country where clinical trial is conducted

United States, 

References & Publications (5)

Fairbairn CE, Sayette MA. A social-attributional analysis of alcohol response. Psychol Bull. 2014 Sep;140(5):1361-82. doi: 10.1037/a0037563. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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." 1 day (laboratory session)
Primary 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. 1 day (laboratory session)
Secondary 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. 1 day (laboratory session)
Secondary Self-Reported Emotion Positive and negative emotion will be assessed during the ambulatory assessment period via self-report on the "8-item Mood Measure." 2-3 week ambulatory assessment period
Secondary Interpersonal Distance Physical proximity to other participants during the experiment 1 day (laboratory session)
Secondary 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. 1 day (laboratory session)
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