Alcohol Drinking, Alcohol Intoxication
Conditions
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.
Interventions
DEVICEAlcohoot
Alcohoot branded smartphone-paired breathalyzer
DEVICEBACtrack Mobile Pro
BACtrack Mobile Pro branded smartphone-paired breathalyzer
DEVICEDRIVESAFE Evoc
DRIVESAFE Evoc branded smartphone-paired breathalyzer
DEVICEBACtrack Vio
BACtrack Vio branded smartphone-paired breathalyzer
DEVICEDrinkmate
Drinkmate branded smartphone-paired breathalyzer
DEVICEFloome
Floome branded smartphone-paired breathalyzer
DEVICEIntoxilyzer 240
Intoxilyzer 240 police grade breathalyzer
Sponsors
University of Pennsylvania
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 39 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Commercial Smartphone-paired Breathalyzers-Set 1 Smartphone-paired mobile breathalyzer-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. | 10 |
| Commercial Smartphone-paired Breathalyzers-Set 2 Smartphone-paired mobile breathalyzer-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. | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Commercial Smartphone-paired Breathalyzers-Set 2 | Total | Commercial Smartphone-paired Breathalyzers-Set 1 |
|---|---|---|---|
| Age, Continuous | 26.3 years STANDARD_DEVIATION 2.5 | 26.8 years STANDARD_DEVIATION 3.2 | 27.2 years STANDARD_DEVIATION 3.9 |
| BMI (mean ± SD) | 24.7 kg/m^2 STANDARD_DEVIATION 4.3 | 24.6 kg/m^2 STANDARD_DEVIATION 4.3 | 24.4 kg/m^2 STANDARD_DEVIATION 4.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 15 Participants | 7 Participants |
| Sex: Female, Male Female | 6 Participants | 11 Participants | 5 Participants |
| Sex: Female, Male Male | 4 Participants | 9 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
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.
Time frame: 8 Hours
Population: Group 1: Alcohoot, Evoc, BACtrack Mobile Pro, Intoxilyzer 240 (A). Group 2: BACtrack Vio, Drinkmate, Floome, Intoxilyzer 240 (B). Percent of Alcohol in Blood - grouped.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alcohoot | Percentage Alcohol in Breath Variability | 0.0912 percentage of alcohol | Standard Deviation 0.0164 |
| BACtrack Mobile Pro | Percentage Alcohol in Breath Variability | 0.0968 percentage of alcohol | Standard Deviation 0.0147 |
| DRIVESAFE Evoc | Percentage Alcohol in Breath Variability | 0.0694 percentage of alcohol | Standard Deviation 0.0074 |
| Intoxilyzer 240 (A) | Percentage Alcohol in Breath Variability | 0.0912 percentage of alcohol | Standard Deviation 0.0099 |
| BACtrack Vio | Percentage Alcohol in Breath Variability | 0.0746 percentage of alcohol | Standard Deviation 0.0312 |
| Drinkmate | Percentage Alcohol in Breath Variability | 0.0495 percentage of alcohol | Standard Deviation 0.0181 |
| Floome | Percentage Alcohol in Breath Variability | 0.0770 percentage of alcohol | Standard Deviation 0.0194 |
| Intoxilyzer 240 (B) | Percentage Alcohol in Breath Variability | 0.0860 percentage of alcohol | Standard Deviation 0.016 |
| Percent of Alcohol in Blood | Percentage Alcohol in Breath Variability | 0.0996 percentage of alcohol | Standard Deviation 0.0165 |
Comparison: Each breathalyzer is compared to the percentage of alcohol in the blood during the time of blood draw (90 minutes).p-value: <0.0001ANOVA
Secondary
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
Time frame: 8 Hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Alcohoot | Differences in Readings on Devices for Percentage of Alcohol in Breath | -0.000836 percentage of alcohol in breath |
| BACtrack Mobile Pro | Differences in Readings on Devices for Percentage of Alcohol in Breath | 0.005853 percentage of alcohol in breath |
| DRIVESAFE Evoc | Differences in Readings on Devices for Percentage of Alcohol in Breath | -0.015698 percentage of alcohol in breath |
| Intoxilyzer 240 (A) | Differences in Readings on Devices for Percentage of Alcohol in Breath | -0.000405 percentage of alcohol in breath |
| BACtrack Vio | Differences in Readings on Devices for Percentage of Alcohol in Breath | -0.014616 percentage of alcohol in breath |
| Drinkmate | Differences in Readings on Devices for Percentage of Alcohol in Breath | -0.006004 percentage of alcohol in breath |