Breathalyzer Validation Study

Study Overview
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Brief Summary
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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.

Official Title
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Reducing Risky Drinking Using Smartphone Paired Breathalyzer

Conditions
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Alcohol Drinking, Alcohol Intoxication

Intervention / Treatment
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* Device: Alcohoot
* Device: BACtrack Mobile Pro
* Device: DRIVESAFE Evoc
* Device: BACtrack Vio
* Device: Drinkmate
* Device: Floome
* Device: Intoxilyzer 240


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Commercial Smartphone-paired breathalyzers-Set 1<br>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<br>* Alcohoot branded smartphone-paired breathalyzer<br>Device: BACtrack Mobile Pro<br>* BACtrack Mobile Pro branded smartphone-paired breathalyzer<br>Device: DRIVESAFE Evoc<br>* DRIVESAFE Evoc branded smartphone-paired breathalyzer<br>Device: Intoxilyzer 240<br>* Intoxilyzer 240 police grade breathalyzer<br>|
| Experimental: Commercial Smartphone-paired breathalyzers-Set 2<br>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: BACtrack Vio<br>* BACtrack Vio branded smartphone-paired breathalyzer<br>Device: Drinkmate<br>* Drinkmate branded smartphone-paired breathalyzer<br>Device: Floome<br>* Floome branded smartphone-paired breathalyzer<br>Device: Intoxilyzer 240<br>* Intoxilyzer 240 police grade breathalyzer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage Alcohol in Breath Variability | 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 | Mean difference in percent of blood in breath (BrAC) between the police-grade and personal, commercial breath testing devices | 8 Hours |