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Active, not recruitingNCT03467191Updated Feb 12, 2025

Behavioral Alcohol Responses (BAR) Study

An Early Phase 1 interventional study of Alcohol and Placebo in Alcohol Drinking, Alcohol Use Disorder and Alcohol Intoxication, sponsored by Carnegie Mellon University. Active, not recruiting at 1 site in United States. Open to participants aged 21 Years to 29 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-12.

Sponsored by Carnegie Mellon University · Early Phase 1, Interventional, and Basic science

Phase
Early Phase 1
Study type
Interventional
Enrollment
782
Allocation
Randomized
Ages
21 Years to 29 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Alcohol Drinking
  • Alcohol Use Disorder
  • Alcohol Intoxication
  • Alcohol; Harmful Use
  • Alcoholism
  • Binge Drinking
03

Who can participate

Ages eligible
21 Years to 29 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 21 to 29 years of age
  • currently drinks alcohol
  • owns a smartphone

Exclusion criteria

Exclusion Criteria:

[Exclusion criteria are masked from public viewing until data collection is complete. Please contact project managers.]

04

Study design

Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
782 participants (actual)

Study arms

  • Experimental
    Alcohol Beverage

    Moderate dose of alcohol (target BAC .08%)

    Drug: Alcohol

  • Placebo comparator
    Placebo Beverage

    Other: Placebo

Interventions

  • DrugAlcohol

    target BAC .08%

  • OtherPlacebo

    placebo beverage

05

What researchers measure

Primary outcomes

  1. Change from Baseline Alcohol Use at 12-months

    Timeline Follow Back Method

    Time frame: 12-month follow-up

  2. Change from Baseline Alcohol Use Disorder Symptoms at 12-months

    Structured Clinical Interview for DSM-5

    Time frame: 12-month follow-up

Secondary outcomes

  1. 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).

    Time frame: 1 day (laboratory session) and 21-day ambulatory assessment period

  2. 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.

    Time frame: 1 day (laboratory session)

  3. 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).

    Time frame: 1 day (laboratory session)

  4. 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).

    Time frame: 1 day (laboratory session)

  5. Alcohol Use

    Quantity of standard drinks consumed.

    Time frame: 21-day ambulatory assessment period

06

Study locations

1 site
  • Carnegie Mellon University
    Pittsburgh, Pennsylvania 15213, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03467191
Lead sponsor
Carnegie Mellon University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA), University of Pittsburgh, Penn State University
Responsible party
Kasey Creswell (Associate Professor, Carnegie Mellon University) — Principal investigator
First posted
Mar 15, 2018
Start date
Feb 13, 2018
Primary completion
Jul 15, 2022
Completion
Oct 31, 2025 (estimated)
Last update
Feb 12, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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