Behavioral Alcohol Responses (BAR) Study

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

Detailed Description
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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.

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

Conditions
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Alcohol Drinking, Alcohol Use Disorder, Alcohol Intoxication, Alcohol; Harmful Use, Alcoholism, Binge Drinking

Intervention / Treatment
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* Drug: Alcohol
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.]

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 29 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alcohol Beverage<br>Moderate dose of alcohol (target BAC .08%) | Drug: Alcohol<br>* target BAC .08%<br>|
| Placebo Comparator: Placebo Beverage<br> | Other: Placebo<br>* placebo beverage<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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) | 
| 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) | 
| 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) | 
| Alcohol Use | Quantity of standard drinks consumed. | 21-day ambulatory assessment period |