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Active, Not Recruiting

NCT Number: NCT03467191

Behavioral Alcohol Responses (BAR) Study

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Alcohol Drinking Alcohol Intoxication Alcohol Use Disorder Alcohol-Related Disorders Alcohol; Harmful Use Alcoholic Intoxication Alcoholism Behavior Binge Drinking Chemically-Induced Disorders Drinking Behavior Mental Disorders Substance-Related Disorders

Age range

21 year–29 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Carnegie Mellon University

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.]

Treatment and study plan

Alcohol

Drug

target BAC .08%

Placebo

Other

placebo beverage

Primary outcomes

  1. Change from Baseline Alcohol Use at 12-months

    Time frame: 12-month follow-up

    Timeline Follow Back Method

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

    Time frame: 12-month follow-up

    Structured Clinical Interview for DSM-5

Secondary outcomes

  1. Subjective Responses to Alcohol

    Time frame: 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).

  2. Social Bonding

    Time frame: 1 day (laboratory session)

    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.

  3. Social Bonding

    Time frame: 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).

  4. Mood

    Time frame: 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).

  5. Alcohol Use

    Time frame: 21-day ambulatory assessment period

    Quantity of standard drinks consumed.

Sponsors and collaborators

Lead sponsor

Carnegie Mellon University

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  • Penn State University
  • University of Pittsburgh

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2025
First posted
Mar 15, 2018
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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