Breathalyzer Validation Study

Not Applicable

Completed

• Conditions: Alcohol Intoxication; Alcohol Drinking
• Interventions: Device: Alcohoot; Device: BACtrack Vio; Device: BACtrack Mobile Pro; Device: Drinkmate; Device: DRIVESAFE Evoc; Device: Floome; Device: Intoxilyzer 240

• Registration Number: NCT04086576
• Lead Sponsor: University of Pennsylvania

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-13
• Primary Completion: 2017-04-17
• Study Completion: 2017-04-17
• Study First Submitted: 2019-09-03
• Study First Submitted QC: 2019-09-09
• Study First Posted: 2019-09-11
• Results First Submitted: 2020-02-20
• Status Verified: 2020-09
• Results First Submitted QC: 2020-09-25
• Last Update Submitted: 2020-09-25
• Results First Posted: 2020-10-20
• Last Update Posted: 2020-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Commercial Smartphone-paired breathalyzers-Set 1	DRIVESAFE Evoc	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.
Commercial Smartphone-paired breathalyzers-Set 1	Alcohoot	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.
Commercial Smartphone-paired breathalyzers-Set 2	Intoxilyzer 240	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.
Commercial Smartphone-paired breathalyzers-Set 1	BACtrack Mobile Pro	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.
Commercial Smartphone-paired breathalyzers-Set 2	Drinkmate	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.
Commercial Smartphone-paired breathalyzers-Set 2	BACtrack Vio	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.
Commercial Smartphone-paired breathalyzers-Set 2	Floome	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.
Commercial Smartphone-paired breathalyzers-Set 1	Intoxilyzer 240	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.

Primary Outcome Measures

Name	Time	Method
Percentage Alcohol in Breath Variability	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 Outcome Measures

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