Behavioral Alcohol Responses (BAR) Study

Predicting Alcohol Use and Alcohol Use Disorder Symptoms From Subjective Responses to Alcohol in a Laboratory Social Setting

This study aims to identify risk factors that prospectively predict alcohol problems in young adults.

Study Overview

• Status: Active, not recruiting
• Conditions: Alcohol Drinking; Alcoholism; Alcohol; Harmful Use; Binge Drinking; Alcohol Use Disorder; Alcohol Intoxication
• Intervention / Treatment: Drug: Alcohol; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 782
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Kasey G. Creswell, PhD; Phone Number: 412-268-3151; Email: kasey@andrew.cmu.edu
• Study Contact Backup: Name: Greta Lyons, BS; Email: glyons@andrew.cmu.edu

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Carnegie Mellon University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 29 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.]

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Alcohol Beverage; Moderate dose of alcohol (target BAC .08%)	Drug: Alcohol; target BAC .08%
Placebo Comparator: Placebo Beverage	Other: Placebo; placebo beverage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Alcohol Use at 12-months	Timeline Follow Back Method	12-month follow-up
Change from Baseline Alcohol Use Disorder Symptoms at 12-months	Structured Clinical Interview for DSM-5	12-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	1 day (laboratory session) and 21-day ambulatory assessment period
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.	1 day (laboratory session)
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).	1 day (laboratory session)
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).	1 day (laboratory session)
Alcohol Use	Quantity of standard drinks consumed.	21-day ambulatory assessment period

Collaborators and Investigators

• Sponsor: Carnegie Mellon University
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA); University of Pittsburgh; Penn State University

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2018
• Primary Completion (Actual): July 15, 2022
• Study Completion (Estimated): July 31, 2024

Study Registration Dates

• First Submitted: March 1, 2018
• First Submitted That Met QC Criteria: March 14, 2018
• First Posted (Actual): March 15, 2018

Study Record Updates

• Last Update Posted (Estimated): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 12, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Drinking Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Alcohol Drinking; Alcoholism; Binge Drinking; Alcoholic Intoxication
• Other Study ID Numbers: STUDY2017_00000346; R01AA025936 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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