ClinicalTrials.gg
CompletedNCT02963818STEADYUpdated Feb 26, 2024

Smartphone Technology: Young Adult Drinking

A Phase 1/2 interventional study of Smartphone breathalyzer device/app use and BAC estimator app use in Alcohol Use, Alcohol Drinking and Drinking Behavior, sponsored by University of Florida. Completed at 1 site in United States. Open to participants aged 21 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-26.

Sponsored by University of Florida · Phase 1/2, Interventional, and Basic science

Phase
Phase 1/2
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
21 Years to 25 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Alcohol Use
  • Alcohol Drinking
  • Drinking Behavior

Keywords

  • Brief intervention
  • Harm reduction
  • Young adult
  • College Student
03

In context

Alcohol Drinking

701 studies on the registry are indexed under Alcohol Drinking; 133 are open to participants now.

This study's enrollment of 110 is close to the median of 122 across 607 interventional studies indexed under Alcohol Drinking.

Browse Alcohol Drinking studies →

Lead sponsor

University of Florida is the lead sponsor of 1,287 studies on the registry; 199 are open to participants now.

Of its 180 completed or terminated interventional studies of FDA-regulated products, 143 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
110 participants (actual)

Study arms

  • Experimental
    Smartphone breathalyzer device & app

    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

  • Experimental
    BAC estimator app

    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

  • Experimental
    Text Messaging

    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

  • OtherSmartphone breathalyzer device/app use

    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.

  • OtherBAC estimator app use

    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.

  • OtherText messaging procedure

    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.

06

What researchers measure

Primary outcomes

  1. Quantity of alcohol consumption

    Compare forms of mobile technology for their effects on alcohol consumption

    Time frame: During one alcohol drinking session, an average of 2 hours

Secondary outcomes

  1. Quantity of alcohol consumption

    Compare forms of mobile technology for their effects on alcohol consumption

    Time frame: two-week field period

07

Study locations

1 site
  • EDGE Laboratory
    Gainesville, Florida 32611, United States
08

References and documents

Publications

  • 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. PubMed 34766785 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02963818
Responsible party
Sponsor
First posted
Nov 15, 2016
Start date
Nov 2016
Primary completion
Jun 20, 2019
Completion
Jun 20, 2020
Last update
Feb 26, 2024

Study contacts

Robert F Leeman, Ph.D.
principal investigator · University of Florida

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion