search
Back to results

Breathalyzer Validation Study (BVS)

Primary Purpose

Alcohol Drinking, Alcohol Intoxication

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Alcohoot
BACtrack Mobile Pro
DRIVESAFE Evoc
BACtrack Vio
Drinkmate
Floome
Intoxilyzer 240
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Alcohol Drinking

Eligibility Criteria

21 Years - 39 Years (Adult)All SexesAccepts 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Commercial Smartphone-paired breathalyzers-Set 1

    Commercial Smartphone-paired breathalyzers-Set 2

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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

    Full Information

    First Posted
    September 3, 2019
    Last Updated
    September 25, 2020
    Sponsor
    University of Pennsylvania
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04086576
    Brief Title
    Breathalyzer Validation Study
    Acronym
    BVS
    Official Title
    Reducing Risky Drinking Using Smartphone Paired Breathalyzer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    December 13, 2016 (Actual)
    Primary Completion Date
    April 17, 2017 (Actual)
    Study Completion Date
    April 17, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Pennsylvania

    4. Oversight

    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
    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alcohol Drinking, Alcohol Intoxication

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Commercial Smartphone-paired breathalyzers-Set 1
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    Commercial Smartphone-paired breathalyzers-Set 2
    Arm Type
    Experimental
    Arm 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.
    Intervention Type
    Device
    Intervention Name(s)
    Alcohoot
    Intervention Description
    Alcohoot branded smartphone-paired breathalyzer
    Intervention Type
    Device
    Intervention Name(s)
    BACtrack Mobile Pro
    Intervention Description
    BACtrack Mobile Pro branded smartphone-paired breathalyzer
    Intervention Type
    Device
    Intervention Name(s)
    DRIVESAFE Evoc
    Intervention Description
    DRIVESAFE Evoc branded smartphone-paired breathalyzer
    Intervention Type
    Device
    Intervention Name(s)
    BACtrack Vio
    Intervention Description
    BACtrack Vio branded smartphone-paired breathalyzer
    Intervention Type
    Device
    Intervention Name(s)
    Drinkmate
    Intervention Description
    Drinkmate branded smartphone-paired breathalyzer
    Intervention Type
    Device
    Intervention Name(s)
    Floome
    Intervention Description
    Floome branded smartphone-paired breathalyzer
    Intervention Type
    Device
    Intervention Name(s)
    Intoxilyzer 240
    Intervention Description
    Intoxilyzer 240 police grade breathalyzer
    Primary Outcome Measure Information:
    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
    Secondary Outcome Measure Information:
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    39 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    M. Kit Delgado, MD, MS
    Organizational Affiliation
    University of Pennsylvania
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    23279560
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    10636603
    Citation
    Easton CJ, Swan S, Sinha R. Prevalence of family violence in clients entering substance abuse treatment. J Subst Abuse Treat. 2000 Jan;18(1):23-8. doi: 10.1016/s0740-5472(99)00019-7.
    Results Reference
    background
    PubMed Identifier
    15907777
    Citation
    Harrison EL, Fillmore MT. Are bad drivers more impaired by alcohol? Sober driving precision predicts impairment from alcohol in a simulated driving task. Accid Anal Prev. 2005 Sep;37(5):882-9. doi: 10.1016/j.aap.2005.04.005.
    Results Reference
    background
    PubMed Identifier
    18179312
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    12724485
    Citation
    Kosten TR, O'Connor PG. Management of drug and alcohol withdrawal. N Engl J Med. 2003 May 1;348(18):1786-95. doi: 10.1056/NEJMra020617. No abstract available.
    Results Reference
    background
    PubMed Identifier
    18042920
    Citation
    Loewenstein G, Brennan T, Volpp KG. Asymmetric paternalism to improve health behaviors. JAMA. 2007 Nov 28;298(20):2415-7. doi: 10.1001/jama.298.20.2415. No abstract available.
    Results Reference
    background
    PubMed Identifier
    21373791
    Citation
    MacKillop J, Amlung MT, Few LR, Ray LA, Sweet LH, Munafo 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.
    Results Reference
    background
    PubMed Identifier
    23216417
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    22690907
    Citation
    McCarthy DM, Niculete ME, Treloar HR, Morris DH, Bartholow BD. Acute alcohol effects on impulsivity: associations with drinking and driving behavior. Addiction. 2012 Dec;107(12):2109-14. doi: 10.1111/j.1360-0443.2012.03974.x. Epub 2012 Aug 10.
    Results Reference
    background
    PubMed Identifier
    9707655
    Citation
    McNeill JA, Sherwood GD, Starck PL, Thompson CJ. Assessing clinical outcomes: patient satisfaction with pain management. J Pain Symptom Manage. 1998 Jul;16(1):29-40. doi: 10.1016/s0885-3924(98)00034-7.
    Results Reference
    background
    PubMed Identifier
    25569175
    Citation
    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. No abstract available.
    Results Reference
    background
    PubMed Identifier
    12503979
    Citation
    Naimi TS, Brewer RD, Mokdad A, Denny C, Serdula MK, Marks JS. Binge drinking among US adults. JAMA. 2003 Jan 1;289(1):70-5. doi: 10.1001/jama.289.1.70.
    Results Reference
    background
    PubMed Identifier
    10669051
    Citation
    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. doi: 10.1016/s0376-8716(99)00071-x.
    Results Reference
    background
    PubMed Identifier
    10780125
    Citation
    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. doi: 10.1037//0022-006x.68.2.250.
    Results Reference
    background
    PubMed Identifier
    17034434
    Citation
    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. doi: 10.1111/j.1360-0443.2006.01581.x.
    Results Reference
    background
    PubMed Identifier
    17074952
    Citation
    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. doi: 10.1176/ajp.2006.163.11.1993.
    Results Reference
    background
    PubMed Identifier
    23596504
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    24603444
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    24913486
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    7289599
    Citation
    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. doi: 10.15288/jsa.1981.42.547. No abstract available.
    Results Reference
    background
    PubMed Identifier
    24881329
    Citation
    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.
    Results Reference
    background

    Learn more about this trial

    Breathalyzer Validation Study

    We'll reach out to this number within 24 hrs