Behavioral Alcohol Responses (BAR) Study

Early Phase 1

Active, not recruiting

• Conditions: Alcohol Drinking; Alcohol Use Disorder; Alcohol Intoxication; Alcohol; Harmful Use; Alcoholism; Binge Drinking
• Interventions: Drug: Alcohol; Other: Placebo

• Registration Number: NCT03467191
• Lead Sponsor: Carnegie Mellon University

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.

Study Timeline

• Study Start: 2018-02-13
• Study First Submitted: 2018-03-01
• Study First Submitted QC: 2018-03-14
• Study First Posted: 2018-03-15
• Primary Completion: 2022-07-15
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-12
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 782

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Alcohol Beverage	Alcohol	Moderate dose of alcohol (target BAC .08%)
Placebo Beverage	Placebo	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Social Bonding	1 day (laboratory session)	Perceived Group Reinforcement Scale, which is a 12-item scale assessing self-reported bonding (1-9 scale, with higher scores indicating more bonding).
Alcohol Use	21-day ambulatory assessment period	Quantity of standard drinks consumed.
Subjective Responses to Alcohol	1 day (laboratory session) and 21-day ambulatory assessment period	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).
Mood	1 day (laboratory session)	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).

Trial Locations

Locations (1)

Carnegie Mellon University; 🇺🇸 Pittsburgh, Pennsylvania, United States