NCT03467191

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
782

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Feb 2018

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 13, 2018

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

March 1, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 15, 2018

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2022

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2025

Completed
Last Updated

February 12, 2025

Status Verified

February 1, 2025

Enrollment Period

4.4 years

First QC Date

March 1, 2018

Last Update Submit

February 10, 2025

Conditions

Alcohol DrinkingAlcohol Use DisorderAlcohol IntoxicationAlcohol; Harmful UseAlcoholismBinge Drinking

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

  • Subjective Responses to Alcohol

    1 day (laboratory session) and 21-day ambulatory assessment period

  • Social Bonding

    1 day (laboratory session)

  • Social Bonding

    1 day (laboratory session)

  • Mood

    1 day (laboratory session)

  • Alcohol Use

    21-day ambulatory assessment period

Study Arms (2)

Alcohol Beverage

EXPERIMENTAL

Moderate dose of alcohol (target BAC .08%)

Drug: Alcohol

Placebo Beverage

PLACEBO COMPARATOR
Other: Placebo

Interventions

AlcoholDRUG

target BAC .08%

Alcohol Beverage
PlaceboOTHER

placebo beverage

Placebo Beverage

Eligibility Criteria

Age21 Years - 29 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsMay be either male or female, but must be same as gender assigned at birth.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carnegie Mellon University

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Alcohol DrinkingAlcoholismAlcoholic IntoxicationBinge Drinking

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Drinking BehaviorBehaviorAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 1, 2018

First Posted

March 15, 2018

Study Start

February 13, 2018

Primary Completion

July 15, 2022

Study Completion

October 31, 2025

Last Updated

February 12, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)