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OpenTrials
Completed

NCT Number: NCT04086576

Breathalyzer Validation Study

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.

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Key information

Conditions

Alcohol Drinking Alcohol Intoxication Alcohol-Related Disorders Alcoholic Intoxication Behavior Chemically-Induced Disorders Drinking Behavior Mental Disorders Substance-Related Disorders

Age range

21 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Alcohoot

Device

Alcohoot branded smartphone-paired breathalyzer

BACtrack Mobile Pro

Device

BACtrack Mobile Pro branded smartphone-paired breathalyzer

DRIVESAFE Evoc

Device

DRIVESAFE Evoc branded smartphone-paired breathalyzer

BACtrack Vio

Device

BACtrack Vio branded smartphone-paired breathalyzer

Drinkmate

Device

Drinkmate branded smartphone-paired breathalyzer

Floome

Device

Floome branded smartphone-paired breathalyzer

Intoxilyzer 240

Device

Intoxilyzer 240 police grade breathalyzer

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

Reducing Risky Drinking Using Smartphone Paired Breathalyzer

Acronym: BVS

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 11, 2019
Registry last updated
Oct 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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