Behavioral Alcohol Responses (BAR) Study

Alcohol Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03467191
• Other study ID #: STUDY2017_00000346
• Secondary ID: R01AA025936
• Status: Active, not recruiting
• Phase: Early Phase 1
• Start date: February 13, 2018
• Est. completion date: July 31, 2024

Study information

• Verified date: February 2024
• Source: Carnegie Mellon University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 782
• Est. completion date: July 31, 2024
• Est. primary completion date: July 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 29 Years

Eligibility

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.]

Related Conditions & MeSH terms

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

Intervention

Drug:
• Alcohol
target BAC .08%

Other:
• Placebo
placebo beverage

Locations

Country	Name	City	State
United States	Carnegie Mellon University	Pittsburgh	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
Carnegie Mellon University	National Institute on Alcohol Abuse and Alcoholism (NIAAA), Penn State University, University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Alcohol Use at 12-months	Timeline Follow Back Method	12-month follow-up
Primary	Change from Baseline Alcohol Use Disorder Symptoms at 12-months	Structured Clinical Interview for DSM-5	12-month follow-up
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Alcohol Use	Quantity of standard drinks consumed.	21-day ambulatory assessment period