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CompletedNCT03449095Updated Jul 31, 2024Results posted

Understanding Alcohol Reward in Social Context

An interventional study of Alcohol in Alcohol Drinking, Alcohol Use Disorder and Alcohol Intoxication, sponsored by University of Illinois at Urbana-Champaign. Completed at 1 site in United States. Open to participants aged 21 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-31.

Sponsored by University of Illinois at Urbana-Champaign · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
640
Allocation
Randomized
Ages
21 Years to 30 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Alcohol Drinking
  • Alcohol Use Disorder
  • Alcohol Intoxication
  • Alcohol; Harmful Use
  • Alcoholism
  • Binge Drinking
03

Who can participate

Ages eligible
21 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Between the ages of 21 and 30
  • Currently drinks alcohol
  • Able to provide at least 2 same-gender friend referrals

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Single (Outcomes assessor)
Enrollment
640 participants (actual)

Study arms

  • Experimental
    Alcohol Administration

    A moderate dose of alcohol (Target BAC .08%)

    Drug: Alcohol

  • No intervention
    Control Beverage Administration

    Participants consume a non-alcoholic beverage

Interventions

  • DrugAlcohol

    Alcohol Target BAC .08%

05

What researchers measure

Primary outcomes

  1. 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." This measure yields two subscales (positive emotion; negative emotion) each ranges from 1 to 6. For positive mood, higher value represents increased alcohol reward. For negative mood, lower value represents increased alcohol reward.

    Time frame: during the laboratory session, up to 9 hours

  2. 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. The score of the scale ranges from 1 to 9. Higher score indicates increased alcohol reward.

    Time frame: during the laboratory session, up to 9 hours

Secondary outcomes

  1. 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.

    Time frame: 1 day (laboratory session)

  2. Self-Reported Emotion

    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

  3. Interpersonal Distance

    Physical proximity to other participants during the experiment

    Time frame: 1 day (laboratory session)

  4. 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.

    Time frame: 1 day (laboratory session)

06

Results

Posted Jul 31, 2024

Participant flow

Participant flow — Overall Study
MilestoneAlcohol AdministrationControl Beverage Administration
Started320320
Completed320320
Not completed00

Outcome measures

PrimarySelf-Reported Emotion

Positive and negative emotion will be assessed during the laboratory beverage-administration session via self-report on the "8-item Mood Measure." This measure yields two subscales (positive emotion; negative emotion) each ranges from 1 to 6. For positive mood, higher value represents increased alcohol reward. For negative mood, lower value represents increased alcohol reward.

Time frame:
during the laboratory session, up to 9 hours
Reported as:
Mean · score on a scale
Self-Reported Emotion
score on a scaleAlcohol AdministrationControl Beverage Administration
Positive Emotion3.49 ± 1.0852.98 ± 1.101
Negative Emotion0.32 ± 0.4470.673 ± 0.750
Statistical analysis
  • Alcohol Administration vs Control Beverage Administration · ANOVA · p = <0.001 (The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance.)
PrimarySelf-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. The score of the scale ranges from 1 to 9. Higher score indicates increased alcohol reward.

Time frame:
during the laboratory session, up to 9 hours
Reported as:
Mean · score on a scale
Self-Reported Social Reinforcement
score on a scaleAlcohol AdministrationControl Beverage Administration
Self-Reported Social Reinforcement7.471 ± 1.1297.180 ± 1.155
Statistical analysis
  • Alcohol Administration vs Control Beverage Administration · ANCOVA · p = .001 (The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance.)
SecondarySocial 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.

Time frame:
1 day (laboratory session)

Results for this outcome have not been posted.

SecondarySelf-Reported Emotion

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

Results for this outcome have not been posted.

SecondaryInterpersonal Distance

Physical proximity to other participants during the experiment

Time frame:
1 day (laboratory session)

Results for this outcome have not been posted.

SecondaryNeuro-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.

Time frame:
1 day (laboratory session)

Results for this outcome have not been posted.

Adverse events

Collected over 6-9 hours (length of the laboratory session). Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Alcohol Administration0/320 (0%)0/320 (0%)0/320 (0%)
Control Beverage Administration0/320 (0%)0/320 (0%)0/320 (0%)

Baseline characteristics

Primary participants in the current study consisted of both eligible individuals who first contacted the lab and their eligible friends. Here we report the total number of individual participants (both initial contacts and their friends) enrolled in the study.

Age, Continuous
Age, Continuous(years)Alcohol AdministrationControl Beverage AdministrationTotal
Mean22.63 ± 1.92322.74 ± 2.10122.69 ± 2.013
Sex: Female, Male
Sex: Female, Male(Participants)Alcohol AdministrationControl Beverage AdministrationTotal
Female160160320
Male160160320
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Alcohol AdministrationControl Beverage AdministrationTotal
Hispanic or Latino6668134
Not Hispanic or Latino254252506
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Alcohol AdministrationControl Beverage AdministrationTotal
American Indian or Alaska Native213
Asian110129239
Native Hawaiian or Other Pacific Islander000
Black or African American131124
White180164344
More than one race151530
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)Alcohol AdministrationControl Beverage AdministrationTotal
United States320320640
Education level
Education level(Years of Education)Alcohol AdministrationControl Beverage AdministrationTotal
Mean16.08 ± 1.71616.09 ± 1.74116.08 ± 1.727
07

Study locations

1 site
  • University of Illinois at Urbana-Champaign
    Champaign, Illinois 61820, United States
08

References and documents

Publications

  • 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. PubMed 2221564 ↗
  • 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. PubMed 28287750 ↗
  • Fairbairn CE, Sayette MA. A social-attributional analysis of alcohol response. Psychol Bull. 2014 Sep;140(5):1361-82. doi: 10.1037/a0037563. PubMed 25180806 ↗
  • 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. PubMed 22760882 ↗
  • 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. PubMed 24016015 ↗

Study documents

  • Protocol and statistical analysis plan · Apr 23, 2024
  • Informed consent form · Feb 22, 2022

Documents are hosted by the registry — open the source record to download them.

09

Registry details

Key details

Study ID
NCT03449095
Lead sponsor
University of Illinois at Urbana-Champaign
Responsible party
Catharine Fairbairn (Associate Professor, University of Illinois at Urbana-Champaign) — Principal investigator
First posted
Feb 28, 2018
Start date
Nov 4, 2017
Primary completion
Jul 5, 2023
Completion
Jul 5, 2023
Results posted
Jul 31, 2024
Last update
Jul 31, 2024

Study contacts

Catharine E Fairbairn, Ph.D.
principal investigator · University of Illinois at Urbana-Champaign

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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