Breathalyzer Validation Study (BVS)

September 25, 2020 updated by: University of Pennsylvania

Reducing Risky Drinking Using Smartphone Paired Breathalyzer

The proposed project will test three commercial cellphone breathalyzers against a police grade breathalyzer device.The study will test the accuracy of these smartphone breathalyzers at assessing Breath Alcohol Content (BrAC) against a standard police grade breathalyzer. This study aims to fill the knowledge gap by determining the validity of smartphone paired breathalyzer devices to accurately assess BrAC. Data collection includes collection of BrAC measurements, as well as survey data.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 39 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 21-39 old
  • Less than 4 drinking days and less than 12 drinks per week on average in the past 2 months
  • Have previously consumed four (women) or five (men) or more standard drinks without problems
  • A valid photo ID
  • Willing to take public transportation home, via septa or an uber rideshare credit.

Exclusion Criteria:

  • Desire alcohol treatment now or received it in the past 6 months
  • Alcohol dependence with withdrawal per DSM-V criteria
  • Non-English-speaking
  • Individuals who have a medical condition or who are taking medication which limits or prevents the consumption of alcohol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Commercial Smartphone-paired breathalyzers-Set 1
All subjects will first be given a priming dose of alcohol containing vodka designed to raise the blood alcohol content based on weight and gender. Blood alcohol content will first be measured with three commercial smartphone-paired breathalyzers: Drivesafe Evoc, Alcohoot, and BacTrack Pro which will be tested in a randomized order and recorded. Participants blood alcohol content will also be measured using the Intoxilyzer 240, a police grade breathalyzer device After the tertiary dose of alcohol, a nurse will perform a blood draw on the participants, which will be used to determine blood alcohol content.
Device: Alcohoot
Alcohoot branded smartphone-paired breathalyzer
Device: BACtrack Mobile Pro
BACtrack Mobile Pro branded smartphone-paired breathalyzer
Device: DRIVESAFE Evoc
DRIVESAFE Evoc branded smartphone-paired breathalyzer
Device: Intoxilyzer 240
Intoxilyzer 240 police grade breathalyzer
EXPERIMENTAL: Commercial Smartphone-paired breathalyzers-Set 2
All subjects will first be given a priming dose of alcohol containing vodka designed to raise the blood alcohol content based on weight and gender. Blood alcohol content will first be measured with three commercial smartphone-paired breathalyzers: BACtrack Vio, Drinkmate, and Floome which will be tested in a randomized order and recorded. Participants blood alcohol content will also be measured using the Intoxilyzer 240, a police grade breathalyzer device After the tertiary dose of alcohol, a nurse will perform a blood draw on the participants, which will be used to determine blood alcohol content.
Device: Intoxilyzer 240
Intoxilyzer 240 police grade breathalyzer
Device: BACtrack Vio
BACtrack Vio branded smartphone-paired breathalyzer
Device: Drinkmate
Drinkmate branded smartphone-paired breathalyzer
Device: Floome
Floome branded smartphone-paired breathalyzer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage Alcohol in Breath Variability
Time Frame: 8 Hours
Difference in Breath Alcohol Concentration (BrAC) from police-grade (Intoxilyzer 240) and consumer smartphone-paired breath testing devices relative to Blood Alcohol Concentration (BAC) measured from blood draw after tertiary dose of alcohol.
8 Hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in Readings on Devices for Percentage of Alcohol in Breath
Time Frame: 8 Hours
Mean difference in percent of blood in breath (BrAC) between the police-grade and personal, commercial breath testing devices
8 Hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 13, 2016

Primary Completion (ACTUAL)

April 17, 2017

Study Completion (ACTUAL)

April 17, 2017

Study Registration Dates

First Submitted

September 3, 2019

First Submitted That Met QC Criteria

September 9, 2019

First Posted (ACTUAL)

September 11, 2019

Study Record Updates

Last Update Posted (ACTUAL)

October 20, 2020

Last Update Submitted That Met QC Criteria

September 25, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 825273

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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