Breathalyzer Validation Study (BVS)

University of Pennsylvania

Status: Completed

Conditions: Alcohol Intoxication; Alcohol Drinking

Treatments: Device: Floome; Device: Alcohoot; Device: BACtrack Mobile Pro; Device: Drinkmate; Device: DRIVESAFE Evoc; Device: Intoxilyzer 240; Device: BACtrack Vio

Study type: Interventional

Funder types: Other

Identifiers

NCT04086576

825273

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 21 to 39 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Commercial Smartphone-paired breathalyzers-Set 1

Experimental group

Description:

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.

Treatment:

Device: BACtrack Mobile Pro

Device: Alcohoot

Device: DRIVESAFE Evoc

Device: Intoxilyzer 240

Commercial Smartphone-paired breathalyzers-Set 2

Experimental group

Description:

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.

Treatment:

Device: Drinkmate

Device: BACtrack Vio

Device: Intoxilyzer 240

Device: Floome