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Trial Outcomes & Findings for Understanding Alcohol Reward in Social Context (NCT NCT03449095)

NCT ID: NCT03449095

Last Updated: 2024-07-31

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

640 participants

Primary outcome timeframe

during the laboratory session, up to 9 hours

Results posted on

2024-07-31

Participant Flow

Participant milestones

Participant milestones
Measure
Alcohol Administration
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) who received a moderate dose of alcohol (Target BAC .08%).
Control Beverage Administration
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) who received a non-alcoholic beverage.
Overall Study
STARTED
320
320
Overall Study
COMPLETED
320
320
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Understanding Alcohol Reward in Social Context

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Alcohol Administration
n=320 Participants
Primary participants in the current study consisted of both eligible individuals who first contacted the lab and their eligible friends. Here we report the data from individual participants (both initial contacts and their friends) who received a moderate dose of alcohol (Target BAC .08%).
Control Beverage Administration
n=320 Participants
Primary participants in the current study consisted of both eligible individuals who first contacted the lab and their eligible friends. Here we report the data from individual participants (both initial contacts and their friends) who received a non-alcoholic beverage.
Total
n=640 Participants
Total of all reporting groups
Age, Continuous
22.63 years
STANDARD_DEVIATION 1.923 • n=93 Participants
22.74 years
STANDARD_DEVIATION 2.101 • n=4 Participants
22.69 years
STANDARD_DEVIATION 2.013 • n=27 Participants
Sex: Female, Male
Female
160 Participants
n=93 Participants
160 Participants
n=4 Participants
320 Participants
n=27 Participants
Sex: Female, Male
Male
160 Participants
n=93 Participants
160 Participants
n=4 Participants
320 Participants
n=27 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
66 Participants
n=93 Participants
68 Participants
n=4 Participants
134 Participants
n=27 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
254 Participants
n=93 Participants
252 Participants
n=4 Participants
506 Participants
n=27 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Race (NIH/OMB)
American Indian or Alaska Native
2 Participants
n=93 Participants
1 Participants
n=4 Participants
3 Participants
n=27 Participants
Race (NIH/OMB)
Asian
110 Participants
n=93 Participants
129 Participants
n=4 Participants
239 Participants
n=27 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Race (NIH/OMB)
Black or African American
13 Participants
n=93 Participants
11 Participants
n=4 Participants
24 Participants
n=27 Participants
Race (NIH/OMB)
White
180 Participants
n=93 Participants
164 Participants
n=4 Participants
344 Participants
n=27 Participants
Race (NIH/OMB)
More than one race
15 Participants
n=93 Participants
15 Participants
n=4 Participants
30 Participants
n=27 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Region of Enrollment
United States
320 participants
n=93 Participants
320 participants
n=4 Participants
640 participants
n=27 Participants
Education level
16.08 Years of Education
STANDARD_DEVIATION 1.716 • n=93 Participants
16.09 Years of Education
STANDARD_DEVIATION 1.741 • n=4 Participants
16.08 Years of Education
STANDARD_DEVIATION 1.727 • n=27 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Alcohol Administration
n=320 Participants
Primary participants in the current study consisted of both eligible individuals who first contacted the lab and their eligible friends. Here we report the data from individual participants (both initial contacts and their friends) who received a moderate dose of alcohol (Target BAC .08%).
Control Beverage Administration
n=320 Participants
Primary participants in the current study consisted of both eligible individuals who first contacted the lab and their eligible friends. Here we report the data from individual participants (both initial contacts and their friends) who received a non-alcoholic beverage.
Self-Reported Emotion
Positive Emotion
3.49 score on a scale
Standard Deviation 1.085
2.98 score on a scale
Standard Deviation 1.101
Self-Reported Emotion
Negative Emotion
0.32 score on a scale
Standard Deviation 0.447
0.673 score on a scale
Standard Deviation 0.750

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Alcohol Administration
n=320 Participants
Primary participants in the current study consisted of both eligible individuals who first contacted the lab and their eligible friends. Here we report the data from individual participants (both initial contacts and their friends) who received a moderate dose of alcohol (Target BAC .08%).
Control Beverage Administration
n=320 Participants
Primary participants in the current study consisted of both eligible individuals who first contacted the lab and their eligible friends. Here we report the data from individual participants (both initial contacts and their friends) who received a non-alcoholic beverage.
Self-Reported Social Reinforcement
7.471 score on a scale
Standard Deviation 1.129
7.180 score on a scale
Standard Deviation 1.155

SECONDARY outcome

Timeframe: 1 day (laboratory session)

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2-3 week ambulatory assessment period

Positive and negative emotion will be assessed during the ambulatory assessment period via self-report on the "8-item Mood Measure."

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 day (laboratory session)

Physical proximity to other participants during the experiment

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 day (laboratory session)

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.

Outcome measures

Outcome data not reported

Adverse Events

Alcohol Administration

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Control Beverage Administration

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Catharine Fairbairn

University of Illinois at Urbana-Champaign

Phone: 215-300-5850

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place