NCT03890484

Brief Summary

The present study will evaluate college students (N=100) from 2- and 4-year colleges/universities between 21-24 years old to assess anxiety, affect, broad social motives (BSM) and peer group influences on drinking and other risk-taking behaviors. This study will employ two sound scientific methods for testing behavior during drinking events (i.e., lab alcohol administration and daily diary) and use novel strategies to compare results of these two methods in the same sample. Using an ad-lib drinking paradigm, students' risk-taking, as measured by the Balloon Analogue Risk Task (BART), will be assessed when alone and during one of two randomly assigned peer group conditions (close friends or new peers). Participants will be allowed to freely drink (within safety limits) with their peer group prior to completing the BART again. These same students will complete daily electronic diaries on four weekends (Thursday - Sunday; total 24 assessments) regarding BSM, motives to drink, peers in their social group, alcohol use and consequences, and if/how their social group changed (e.g., few close friends to large party with many new peers) during the drinking event. Competing hypotheses will be tested such that: 1) anxiety is expected to be a stronger predictor of drinking behavior and greater differences in risk-taking in the new peer condition than close friend condition or 2) BSM is expected to be a stronger predictor of drinking behavior and greater differences in risk-taking in the close friend condition than new peers condition. Results are expected to be replicated in the daily diary reports. Further, this multimethod approach will allow us to evaluate how behavior assessed in the lab predicts naturally occurring behaviors in an uncontrolled setting. For example, the investigators will assess whether greater increases in self-reported risk-taking from baseline to after entering peer groups in the bar lab setting will predict heavier drinking on nights when most drinking companions are close friends reported during daily diary.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 26, 2019

Completed
10 months until next milestone

Study Start

First participant enrolled

January 25, 2020

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 3, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 3, 2022

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

April 17, 2024

Completed
Last Updated

April 17, 2024

Status Verified

March 1, 2024

Enrollment Period

2.4 years

First QC Date

December 20, 2018

Results QC Date

December 21, 2023

Last Update Submit

March 22, 2024

Conditions

Keywords

Alcohol useRisk-takingAnxietyMotivesMultimethod

Outcome Measures

Primary Outcomes (5)

  • Alcohol Use

    Number of drinks consumed

    During 1 hour ad-lib period, starting an average of 1 hour after Baseline.

  • Alcohol Use - Daily Diary

    Number of drinks consumed, self-reported the morning after drinking events

    4 weeks following ad-lib.

  • Alcohol Consequences

    Self-report of the Young Adult Alcohol Problems Screening Test (YAAPST). Count of number of consequences experienced. Range: 0-27. Higher scores represent more consequences experienced.

    4 weeks following ad-lib.

  • Risk-taking

    Scores on the Balloon Analogue Risk Task (BART). Scores are calculated by adding the number of pumps for unexploded balloons, with higher scores reflecting greater risk-taking. Range varies - explosions are at a random point between 1 and 128 pumps.

    Change from baseline (alone) to 20 minutes following Peer Type intervention.

  • Risk-taking

    Scores on the Balloon Analogue Risk Task (BART). Scores are calculated by adding the number of pumps for unexploded balloons, with higher scores reflecting greater risk-taking. Range varies - explosions are at a random point between 1 and 128 pumps.

    Change from baseline (alone) to immediately following ad-lib, an average of 2 hours after baseline.

Study Arms (2)

New Peers

EXPERIMENTAL

Participants will drink with two new peers (i.e. strangers), who they did not know prior to the study and their Peer Type.

Behavioral: Peer Type - New Peer

Close Friends

EXPERIMENTAL

Participants will recruit and drink with two of their close friends and their Peer Type

Behavioral: Peer Type - Close Friends

Interventions

Participants drink with 2 unfamiliar confederate peers

New Peers

Participants drink with 2 close friends

Close Friends

Eligibility Criteria

Age21 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • currently enrolled in college
  • has consumed 3 or more alcoholic drinks in one sitting at least once in the past month
  • drinking frequency of once a week

You may not qualify if:

  • past-month alcohol
  • past-month other substance dependence,
  • past-month mood disorder
  • past-month anxiety disorder
  • past-moth suicidal ideation
  • excessive alcohol use reaching a BAC greater than .30% in past month
  • history of serious medical conditions
  • regular use of prescription psychotropic or pain medication
  • history of negative reactions to alcohol
  • history of treatment for alcohol use disorder
  • pregnancy
  • nursing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Center for the Study of Health and Risk Behaviors

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Alcohol DrinkingRisk-TakingAnxiety Disorders

Condition Hierarchy (Ancestors)

Drinking BehaviorBehaviorMental Disorders

Results Point of Contact

Title
Dr. Jessica Canning
Organization
University of Washington

Study Officials

  • Mary E Larimer, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to one of two conditions, which will run in parallel.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, School of Medicine, Psychiatry and Behavioral Sciences

Study Record Dates

First Submitted

December 20, 2018

First Posted

March 26, 2019

Study Start

January 25, 2020

Primary Completion

July 3, 2022

Study Completion

July 3, 2022

Last Updated

April 17, 2024

Results First Posted

April 17, 2024

Record last verified: 2024-03

Locations