Alcohol DrinkingNCT03449095
Understanding Alcohol Reward in Social Context
A study testing Alcohol in people with Alcohol Drinking and Alcohol Use Disorder, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial summary
In this study, the investigators examine whether emotional and social reward from alcohol varies depending on the social context of consumption. 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, Alcohol Intoxication
- What is being tested?
- Alcohol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 640 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2017to 5 Jul 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Currently drinks alcohol
- Able to provide at least 2 same-gender friend referrals
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Urbana-Champaign
Champaign, Illinois, 61820
About this study
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
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.
- Conditions
- Alcohol Drinking, Alcohol Use Disorder, Alcohol Intoxication, Alcohol; Harmful Use, Alcoholism, Binge Drinking
- Being tested
- Alcohol
- 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.
AlcoholDrug
Alcohol Target BAC .08%
| Study group | Role | What they receive |
|---|---|---|
| Alcohol Administration | Experimental | A moderate dose of alcohol (Target BAC .08%) Receives: Drug: Alcohol |
| Control Beverage Administration | No intervention | Participants consume a non-alcoholic beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: during the laboratory session, up to 9 hours
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.
Measured: during the laboratory session, up to 9 hours
Secondary outcomes (4)
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.
Measured: 1 day (laboratory session)
Self-Reported Emotion
Positive and negative emotion will be assessed during the ambulatory assessment period via self-report on the "8-item Mood Measure."
Measured: 2-3 week ambulatory assessment period
Interpersonal Distance
Physical proximity to other participants during the experiment
Measured: 1 day (laboratory session)
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.
Measured: 1 day (laboratory session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2018
- Study start4 Nov 2017
- Primary completion5 Jul 2023
- Study completion5 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 640 participants (actual)
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
- Investigators
- Catharine E Fairbairn, Ph.D., Principal investigator, University of Illinois at Urbana-Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03449095
- Sponsor's protocol ID
- R01AA025969
- Status last verified
- Jul 2024
- First submitted
- 23 Nov 2017
- Last updated
- 31 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 2221564Fairbairn 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 28287750Fairbairn CE, Sayette MA. A social-attributional analysis of alcohol response. Psychol Bull. 2014 Sep;140(5):1361-82. doi: 10.1037/a0037563.
PubMed 25180806Sayette 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 22760882Fairbairn 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 at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03449095
- Acronym / sponsor ID
- R01AA025969
- Conditions
- Alcohol Drinking, Alcohol Use Disorder, Alcohol Intoxication, Alcohol; Harmful Use, Alcoholism, Binge Drinking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 640 participants (actual)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Study start
- 4 Nov 2017 (actual)
- Primary completion
- 5 Jul 2023 (actual)
- Study completion
- 5 Jul 2023 (actual)
- First posted
- 28 Feb 2018 (actual)
- Results
- Posted 31 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alcohol Administration | Experimental | Drug: AlcoholA moderate dose of alcohol (Target BAC .08%) |
| Control Beverage Administration | No intervention | –Participants consume a non-alcoholic beverage |
Who may qualify
- Ages
- 21 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Between the ages of 21 and 30
- Currently drinks alcohol
- Able to provide at least 2 same-gender friend referrals
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| AlcoholAlcohol Target BAC .08% | Drug | Alcohol Administration |
Primary outcome
Self-Reported Emotion
Time frame: during the laboratory session, up to 9 hours
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.
Self-Reported Social Reinforcement
Time frame: during the laboratory session, up to 9 hours
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.
4 secondary outcomes
Social Bonding
Time frame: 1 day (laboratory session)
Self-Reported Emotion
Time frame: 2-3 week ambulatory assessment period
Interpersonal Distance
Time frame: 1 day (laboratory session)
Neuro-cognitive Social Engagement
Time frame: 1 day (laboratory session)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 2221564Steele 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.
- Background: PubMed 28287750Fairbairn 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.
- Background: PubMed 25180806Fairbairn CE, Sayette MA. A social-attributional analysis of alcohol response. Psychol Bull. 2014 Sep;140(5):1361-82. doi: 10.1037/a0037563.
- Background: PubMed 22760882Sayette 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.
- Background: PubMed 24016015Fairbairn 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.
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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. This study is not recruiting at the moment.
Catharine E Fairbairn, Ph.D. principal investigator
University of Illinois at Urbana-Champaign
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alcohol in people with Alcohol Drinking and Alcohol Use Disorder, run by University of Illinois at Urbana-Champaign at 1 site 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 31 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Reported Emotion (time frame: during the laboratory session, up to 9 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03449095, which also lists 5 linked publications.
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 31 Jul 2024.