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Clinical Trials/NCT03467191
NCT03467191
Active, not recruiting
Early Phase 1

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

Carnegie Mellon University1 site in 1 country782 target enrollmentFebruary 13, 2018

Overview

Phase
Early Phase 1
Intervention
Alcohol
Conditions
Alcohol Drinking
Sponsor
Carnegie Mellon University
Enrollment
782
Locations
1
Primary Endpoint
Change from Baseline Alcohol Use at 12-months
Status
Active, not recruiting
Last Updated
last year

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
February 13, 2018
End Date
October 31, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kasey Creswell

Associate Professor

Carnegie Mellon University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Arms & Interventions

Alcohol Beverage

Moderate dose of alcohol (target BAC .08%)

Intervention: Alcohol

Placebo Beverage

Intervention: Placebo

Outcomes

Primary Outcomes

Change from Baseline Alcohol Use at 12-months

Time Frame: 12-month follow-up

Timeline Follow Back Method

Change from Baseline Alcohol Use Disorder Symptoms at 12-months

Time Frame: 12-month follow-up

Structured Clinical Interview for DSM-5

Secondary Outcomes

  • Social Bonding(1 day (laboratory session))
  • Alcohol Use(21-day ambulatory assessment period)
  • Subjective Responses to Alcohol(1 day (laboratory session) and 21-day ambulatory assessment period)
  • Mood(1 day (laboratory session))

Study Sites (1)

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