Behavioral Alcohol Responses (BAR) Study
Primary Purpose
Alcohol Drinking, Alcohol Use Disorder, Alcohol Intoxication
Status
Active
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Alcohol
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Alcohol Drinking
Eligibility Criteria
Inclusion Criteria:
- 21 to 29 years of age
- currently drinks alcohol
- owns a smartphone
Exclusion Criteria:
[Exclusion criteria are masked from public viewing until data collection is complete. Please contact project managers.]
Sites / Locations
- Carnegie Mellon University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Alcohol Beverage
Placebo Beverage
Arm Description
Moderate dose of alcohol (target BAC .08%)
Outcomes
Primary Outcome Measures
Change from Baseline Alcohol Use at 12-months
Timeline Follow Back Method
Change from Baseline Alcohol Use Disorder Symptoms at 12-months
Structured Clinical Interview for DSM-5
Secondary Outcome Measures
Subjective Responses to Alcohol
Participants will indicate how they feel after drinking alcohol using the Brief-Biphasic Alcohol Effects Scale, which is a 6-item scale assessing alcohol's acute stimulant and sedative effects (0-10 scale, with higher scores indicating higher values).
Social Bonding
Facial expressions of emotions using Paul Ekman's Facial Action Coding System (FACS). The duration of AUs associated with positive and negative affect will be coded.
Social Bonding
Perceived Group Reinforcement Scale, which is a 12-item scale assessing self-reported bonding (1-9 scale, with higher scores indicating more bonding).
Mood
8-item Mood Measure, which is an 8-item scale assessing mood items from each of the four quadrants of the affective circumplex (with higher scores indicating more felt emotion).
Alcohol Use
Quantity of standard drinks consumed.
Full Information
NCT ID
NCT03467191
First Posted
March 1, 2018
Last Updated
February 13, 2023
Sponsor
Carnegie Mellon University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA), University of Pittsburgh, Penn State University
1. Study Identification
Unique Protocol Identification Number
NCT03467191
Brief Title
Behavioral Alcohol Responses (BAR) Study
Official Title
Predicting Alcohol Use and Alcohol Use Disorder Symptoms From Subjective Responses to Alcohol in a Laboratory Social Setting
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 13, 2018 (Actual)
Primary Completion Date
July 15, 2022 (Actual)
Study Completion Date
July 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Carnegie Mellon University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA), University of Pittsburgh, Penn State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aims to identify risk factors that prospectively predict alcohol problems in young adults.
Detailed Description
The vast majority of alcohol use takes place in social settings, yet nearly all human experimental work has administered alcohol to individuals in isolation. This study will examine the effects of alcohol in social groups and test whether these responses predict the escalation of alcohol use and development of alcohol use disorder symptoms. Participants will also complete smartphone surveys querying subjective responses to alcohol in their daily lives.
N=400 male and female young adults will participate in a laboratory session with two other participants and will consume either a moderate dose of alcohol or placebo beverage. Subjective and objective responses to alcohol will be assessed. Participants will also complete surveys on their smartphones; these will occur during drinking episodes and at random times throughout the day. Follow-up sessions will occur at 6-months and 12-months, to collect information about drinking habits and potential alcohol-related problems.
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
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
782 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Alcohol Beverage
Arm Type
Experimental
Arm Description
Moderate dose of alcohol (target BAC .08%)
Arm Title
Placebo Beverage
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Alcohol
Intervention Description
target BAC .08%
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
placebo beverage
Primary Outcome Measure Information:
Title
Change from Baseline Alcohol Use at 12-months
Description
Timeline Follow Back Method
Time Frame
12-month follow-up
Title
Change from Baseline Alcohol Use Disorder Symptoms at 12-months
Description
Structured Clinical Interview for DSM-5
Time Frame
12-month follow-up
Secondary Outcome Measure Information:
Title
Subjective Responses to Alcohol
Description
Participants will indicate how they feel after drinking alcohol using the Brief-Biphasic Alcohol Effects Scale, which is a 6-item scale assessing alcohol's acute stimulant and sedative effects (0-10 scale, with higher scores indicating higher values).
Time Frame
1 day (laboratory session) and 21-day ambulatory assessment period
Title
Social Bonding
Description
Facial expressions of emotions using Paul Ekman's Facial Action Coding System (FACS). The duration of AUs associated with positive and negative affect will be coded.
Time Frame
1 day (laboratory session)
Title
Social Bonding
Description
Perceived Group Reinforcement Scale, which is a 12-item scale assessing self-reported bonding (1-9 scale, with higher scores indicating more bonding).
Time Frame
1 day (laboratory session)
Title
Mood
Description
8-item Mood Measure, which is an 8-item scale assessing mood items from each of the four quadrants of the affective circumplex (with higher scores indicating more felt emotion).
Time Frame
1 day (laboratory session)
Title
Alcohol Use
Description
Quantity of standard drinks consumed.
Time Frame
21-day ambulatory assessment period
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
29 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
21 to 29 years of age
currently drinks alcohol
owns a smartphone
Exclusion Criteria:
[Exclusion criteria are masked from public viewing until data collection is complete. Please contact project managers.]
Facility Information:
Facility Name
Carnegie Mellon University
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Behavioral Alcohol Responses (BAR) Study
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