BVS: Breathalyzer Validation Study

• Sponsor: University of Pennsylvania (Other)
• Overall Status: Completed
• CT.gov ID: NCT04086576
• Collaborator: (none)
• Enrollment: 20
• Arms: 2
• Actual Duration (Months): 4.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Alcohol Drinking; Alcohol Intoxication	Device: Alcohoot; Device: BACtrack Mobile Pro; Device: DRIVESAFE Evoc; Device: BACtrack Vio; Device: Drinkmate; Device: Floome; Device: Intoxilyzer 240	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Reducing Risky Drinking Using Smartphone Paired Breathalyzer
• Actual Study Start Date: Dec 13, 2016
• Actual Primary Completion Date: Apr 17, 2017
• Actual Study Completion Date: Apr 17, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Commercial Smartphone-paired breathalyzers-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.	Device: Alcohoot; Alcohoot branded smartphone-paired breathalyzer; Device: BACtrack Mobile Pro; BACtrack Mobile Pro branded smartphone-paired breathalyzer; Device: DRIVESAFE Evoc; DRIVESAFE Evoc branded smartphone-paired breathalyzer; Device: Intoxilyzer 240; Intoxilyzer 240 police grade breathalyzer
Experimental: Commercial Smartphone-paired breathalyzers-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.	Device: BACtrack Vio; BACtrack Vio branded smartphone-paired breathalyzer; Device: Drinkmate; Drinkmate branded smartphone-paired breathalyzer; Device: Floome; Floome branded smartphone-paired breathalyzer; Device: Intoxilyzer 240; Intoxilyzer 240 police grade breathalyzer

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 39 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Pennsylvania

Investigators

• Principal Investigator: M. Kit Delgado, MD, MS, University of Pennsylvania

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 21, 2017

More Information

Publications

• Alessi SM, Petry NM. A randomized study of cellphone technology to reinforce alcohol abstinence in the natural environment. Addiction. 2013 May;108(5):900-9. doi: 10.1111/add.12093. Epub 2013 Jan 30.
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• Harrison EL, Marczinski CA, Fillmore MT. Driver training conditions affect sensitivity to the impairing effects of alcohol on a simulated driving test [corrected]. Exp Clin Psychopharmacol. 2007 Dec;15(6):588-98. doi: 10.1037/1064-1297.15.6.588. Erratum in: Exp Clin Psychopharmacol. 2008 Apr;16(2):177.
• Kosten TR, O'Connor PG. Management of drug and alcohol withdrawal. N Engl J Med. 2003 May 1;348(18):1786-95. Review.
• Loewenstein G, Brennan T, Volpp KG. Asymmetric paternalism to improve health behaviors. JAMA. 2007 Nov 28;298(20):2415-7.
• MacKillop J, Amlung MT, Few LR, Ray LA, Sweet LH, Munafò MR. Delayed reward discounting and addictive behavior: a meta-analysis. Psychopharmacology (Berl). 2011 Aug;216(3):305-21. doi: 10.1007/s00213-011-2229-0. Epub 2011 Mar 4.
• Marczinski CA, Stamates AL. Artificial sweeteners versus regular mixers increase breath alcohol concentrations in male and female social drinkers. Alcohol Clin Exp Res. 2013 Apr;37(4):696-702. doi: 10.1111/acer.12039. Epub 2012 Dec 6.
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• Patel MS, Asch DA, Volpp KG. Wearable devices as facilitators, not drivers, of health behavior change. JAMA. 2015 Feb 3;313(5):459-60. doi: 10.1001/jama.2014.14781.
• Petry NM, Martin B, Cooney JL, Kranzler HR. Give them prizes, and they will come: contingency management for treatment of alcohol dependence. J Consult Clin Psychol. 2000 Apr;68(2):250-7.
• Petry NM. A comprehensive guide to the application of contingency management procedures in clinical settings. Drug Alcohol Depend. 2000 Feb 1;58(1-2):9-25. Review.
• Prendergast M, Podus D, Finney J, Greenwell L, Roll J. Contingency management for treatment of substance use disorders: a meta-analysis. Addiction. 2006 Nov;101(11):1546-60. Review.
• Roll JM, Petry NM, Stitzer ML, Brecht ML, Peirce JM, McCann MJ, Blaine J, MacDonald M, DiMaria J, Lucero L, Kellogg S. Contingency management for the treatment of methamphetamine use disorders. Am J Psychiatry. 2006 Nov;163(11):1993-9.
• Senecal N, Wang T, Thompson E, Kable JW. Normative arguments from experts and peers reduce delay discounting. Judgm Decis Mak. 2012 Sep 1;7(5):568-589.
• Sloan FA, Eldred LM, Xu Y. The behavioral economics of drunk driving. J Health Econ. 2014 May;35:64-81. doi: 10.1016/j.jhealeco.2014.01.005. Epub 2014 Feb 11.
• Van Dyke N, Fillmore MT. Acute effects of alcohol on inhibitory control and simulated driving in DUI offenders. J Safety Res. 2014 Jun;49:5-11. doi: 10.1016/j.jsr.2014.02.004. Epub 2014 Mar 22.
• Watson PE, Watson ID, Batt RD. Prediction of blood alcohol concentrations in human subjects. Updating the Widmark Equation. J Stud Alcohol. 1981 Jul;42(7):547-56.
• White A, Hingson R. The burden of alcohol use: excessive alcohol consumption and related consequences among college students. Alcohol Res. 2013;35(2):201-18. Review.

• Responsible Party: University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT04086576
• Other Study ID Numbers: 825273
• First Posted: Sep 11, 2019
• Last Update Posted: Oct 20, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Alcoholic Intoxication; Alcohol Drinking

Study Results

Participant Flow

Arm/Group Title	Commercial Smartphone-paired Breathalyzers-Set 1	Commercial Smartphone-paired Breathalyzers-Set 2
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	10	10
COMPLETED	10	10
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Commercial Smartphone-paired Breathalyzers-Set 1	Commercial Smartphone-paired Breathalyzers-Set 2	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	10	10	20
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	27.2 (3.9)	26.3 (2.5)	26.8 (3.2)
Sex: Female, Male (Count of Participants)
Female	5 50%	6 60%	11 55%
Male	5 50%	4 40%	9 45%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	2 20%	1 10%	3 15%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 10%	1 10%	2 10%
White	7 70%	8 80%	15 75%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
BMI (mean ± SD) (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	24.4 (4.6)	24.7 (4.3)	24.6 (4.3)

Outcome Measures

1. Primary Outcome

Title	Percentage Alcohol in Breath Variability
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Alcohoot	BACtrack Mobile Pro	DRIVESAFE Evoc	Intoxilyzer 240 (A)	BACtrack Vio	Drinkmate	Floome	Intoxilyzer 240 (B)	Percent of Alcohol in Blood
Arm/Group Description	Alcohoot branded smartphone-paired breathalyzer	BACtrack Mobile Pro branded smartphone-paired breathalyzer	DRIVESAFE Evoc branded smartphone-paired breathalyzer	Intoxilyzer 240 police grade breathalyzer	BACtrack Vio branded smartphone-paired breathalyzer	Drinkmate branded smartphone-paired breathlyzer	Floome branded smartphone-paired breathalyzer	Intoxilyzer 240 police grade breathalyzer	Percentage of Alcohol in Blood measured from blood draw
Measure Participants	10	10	10	10	10	10	10	10	20
Mean (Standard Deviation) [percentage of alcohol]	0.0912 (0.0164)	0.0968 (0.0147)	0.0694 (0.0074)	0.0912 (0.0099)	0.0746 (0.0312)	0.0495 (0.0181)	0.0770 (0.0194)	0.0860 (0.0160)	0.0996 (0.0165)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intoxilyzer 240 (A), Intoxilyzer 240 (B)
	Comments	Each breathalyzer is compared to the percentage of alcohol in the blood during the time of blood draw (90 minutes).
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<.0001
	Comments	Yes, used Tukey Kramer pairwise comparisons to adjust for multiple comparisons
	Method	ANOVA
	Comments	ANOVA in repeated measures

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Alcohoot	BACtrack Mobile Pro	DRIVESAFE Evoc	BACtrack Vio	Drinkmate	Floome
Arm/Group Description	Alcohoot branded smartphone-paired breathalyzer	BACtrack Mobile Pro branded smartphone-paired breathalyzer	DRIVESAFE Evoc branded smartphone-paired breathalyzer	BACtrack Vio branded smartphone-paired breathalyzer	Drinkmate branded smartphone-paired breathlyzer	Floome branded smartphone-paired breathalyzer
Measure Participants	10	10	10	10	10	10
Mean (95% Confidence Interval) [percentage of alcohol in breath]	-0.000836	0.005853	-0.015698	-0.000405	-0.014616	-0.006004

Adverse Events

Time Frame	8 hours
Adverse Event Reporting Description	Screening for eligibility reduced risk of all risk mortality
Arm/Group Title	Commercial Smartphone-paired Breathalyzers-Set 1		Commercial Smartphone-paired Breathalyzers-Set 2
Arm/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. Alcohoot: Alcohoot branded smartphone-paired breathalyzer BACtrack Mobile Pro: BACtrack Mobile Pro branded smartphone-paired breathalyzer DRIVESAFE Evoc: DRIVESAFE Evoc branded smartphone-paired breathalyzer Intoxilyzer 240: Intoxilyzer 240 police grade breathalyzer		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. BACtrack Vio: BACtrack Vio branded smartphone-paired breathalyzer Drinkmate: Drinkmate branded smartphone-paired breathalyzer Floome: Floome branded smartphone-paired breathalyzer Intoxilyzer 240: Intoxilyzer 240 police grade breathalyzer
All Cause Mortality
	Commercial Smartphone-paired Breathalyzers-Set 1		Commercial Smartphone-paired Breathalyzers-Set 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)
Serious Adverse Events
	Commercial Smartphone-paired Breathalyzers-Set 1		Commercial Smartphone-paired Breathalyzers-Set 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)
Other (Not Including Serious) Adverse Events
	Commercial Smartphone-paired Breathalyzers-Set 1		Commercial Smartphone-paired Breathalyzers-Set 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.