Behavioral Alcohol Responses (BAR) Study

• Sponsor: Carnegie Mellon University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03467191
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH), University of Pittsburgh (Other), Penn State University (Other)
• Enrollment: 400
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 65.5
• Patients Per Site Per Month: 6.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Alcohol Drinking; Alcohol Use Disorder; Alcohol Intoxication; Alcohol; Harmful Use; Alcoholism; Binge Drinking	Drug: Alcohol; Other: Placebo	Early Phase 1

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 400 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Predicting Alcohol Use and Alcohol Use Disorder Symptoms From Subjective Responses to Alcohol in a Laboratory Social Setting
• Actual Study Start Date: Feb 13, 2018
• Actual Primary Completion Date: Jul 15, 2022
• Anticipated Study Completion Date: Jul 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change from Baseline Alcohol Use at 12-months [12-month follow-up]

   Timeline Follow Back Method

2. Change from Baseline Alcohol Use Disorder Symptoms at 12-months [12-month follow-up]

   Structured Clinical Interview for DSM-5

Secondary Outcome Measures

1. 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).

2. Social Bonding [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 [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 [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 [21-day ambulatory assessment period]

   Quantity of standard drinks consumed.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 29 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.]

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Carnegie Mellon University	Pittsburgh	Pennsylvania	United States	15213

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kasey Creswell, Associate Professor, Carnegie Mellon University
• ClinicalTrials.gov Identifier: NCT03467191
• Other Study ID Numbers: STUDY2017_00000346; R01AA025936
• First Posted: Mar 15, 2018
• Last Update Posted: Jul 26, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Alcoholism; Binge Drinking; Alcoholic Intoxication; Alcohol Drinking

Study Results

No Results Posted as of Jul 26, 2022