NCT02963818

Brief Summary

Exploring technology based tools to reduce drinking is important. The purpose of this research study is to compare different BAC monitoring apps for their effects on alcohol drinking and ratings of usability among young adults.This study will be conducted in six phases: a web-based and in-person screening assessment; brief counseling session on the day before the alcohol drinking session; brief appointment on the day of the alcohol drinking session; alcohol drinking session; two-week field period; and a follow-up appointment. Participation in this study will last approximately two months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2016

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

November 1, 2016

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

November 8, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 15, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2020

Completed
Last Updated

February 26, 2024

Status Verified

February 1, 2024

Enrollment Period

2.6 years

First QC Date

November 8, 2016

Last Update Submit

February 23, 2024

Conditions

Keywords

Brief interventionHarm reductionYoung adultCollege Student

Outcome Measures

Primary Outcomes (1)

  • Quantity of alcohol consumption

    Compare forms of mobile technology for their effects on alcohol consumption

    During one alcohol drinking session, an average of 2 hours

Secondary Outcomes (1)

  • Quantity of alcohol consumption

    two-week field period

Study Arms (3)

Smartphone breathalyzer device & app

EXPERIMENTAL

This is a small device that connects to a smartphone with an accompanying app that produces accurate breath alcohol readings when a user blows into a small tube attached to the device. Participants randomized to this study condition will have the opportunity to use this device and app during an alcohol drinking session in an actual bar and during a two-week field period.

Other: Smartphone breathalyzer device/app use

BAC estimator app

EXPERIMENTAL

This is an app that produces estimated blood alcohol content (eBAC) readings based on sex, weight, number of drinks and time taken to consume drinks. Participants randomized to this study condition will have the opportunity to use this app during an alcohol drinking session in an actual bar and during a two-week field period.

Other: BAC estimator app use

Text Messaging

EXPERIMENTAL

A procedure whereby one sends a text message to the phone one is using after each alcoholic drink. Participants randomized to this study condition will have the opportunity to the text messaging procedure during an alcohol drinking session in an actual bar and during a two-week field period.

Other: Text messaging procedure

Interventions

Participants randomized to this condition will be able to blow into the smartphone breathalyzer after consuming each alcoholic drink, which produces an accurate breath alcohol reading on the app. These breath alcohol readings may inform participants' subsequent decisions regarding drinking.

Smartphone breathalyzer device & app

Participants randomized to this condition will be able to make an entry into the BAC estimator app after consuming each alcoholic drink, which produces an estimated blood alcohol concentration based on the individual's sex, weight, number of alcoholic drinks and time spent drinking alcohol. These estimated blood alcohol concentrations may inform participants' subsequent decisions regarding drinking.

BAC estimator app

Participants randomized to this condition will be instructed to send a text to a smartphone they will use for the study after each alcoholic drink. A consideration of the number of texts sent may inform participants' subsequent decisions regarding drinking.

Text Messaging

Eligibility Criteria

Age21 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Be able to read/write English and complete study assessments
  • Drink alcohol regularly

You may not qualify if:

  • Test positive on a urine test for use of certain illegal drugs
  • Undergraduate student enrolled at the University of Florida
  • Graduate students from the College of Health and Human Performance at the University of Florida
  • Pregnant, or currently breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

EDGE Laboratory

Gainesville, Florida, 32611, United States

Location

Related Publications (1)

  • Leeman RF, Berey BL, Frohe T, Rowland BHP, Martens MP, Fucito LM, Stellefson M, Nixon SJ, O'Malley SS. A combined laboratory and field test of a smartphone breath alcohol device and blood alcohol concentration estimator to facilitate moderate drinking among young adults. Psychol Addict Behav. 2022 Sep;36(6):710-723. doi: 10.1037/adb0000780. Epub 2021 Nov 11.

MeSH Terms

Conditions

Alcohol DrinkingDrinking BehaviorHarm Reduction

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Robert F Leeman, Ph.D.

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2016

First Posted

November 15, 2016

Study Start

November 1, 2016

Primary Completion

June 20, 2019

Study Completion

June 20, 2020

Last Updated

February 26, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations