NCT04086576

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 13, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 17, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 17, 2017

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

September 3, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 11, 2019

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

October 20, 2020

Completed
Last Updated

October 20, 2020

Status Verified

September 1, 2020

Enrollment Period

4 months

First QC Date

September 3, 2019

Results QC Date

February 20, 2020

Last Update Submit

September 25, 2020

Conditions

Alcohol DrinkingAlcohol Intoxication

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Differences in Readings on Devices for Percentage of Alcohol in Breath

    8 Hours

Study Arms (2)

Commercial Smartphone-paired breathalyzers-Set 1

EXPERIMENTAL

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: AlcohootDevice: BACtrack Mobile ProDevice: DRIVESAFE EvocDevice: Intoxilyzer 240

Commercial Smartphone-paired breathalyzers-Set 2

EXPERIMENTAL

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 VioDevice: DrinkmateDevice: FloomeDevice: Intoxilyzer 240

Interventions

AlcohootDEVICE

Alcohoot branded smartphone-paired breathalyzer

Commercial Smartphone-paired breathalyzers-Set 1
BACtrack Mobile ProDEVICE

BACtrack Mobile Pro branded smartphone-paired breathalyzer

Commercial Smartphone-paired breathalyzers-Set 1
DRIVESAFE EvocDEVICE

DRIVESAFE Evoc branded smartphone-paired breathalyzer

Commercial Smartphone-paired breathalyzers-Set 1
BACtrack VioDEVICE

BACtrack Vio branded smartphone-paired breathalyzer

Commercial Smartphone-paired breathalyzers-Set 2
DrinkmateDEVICE

Drinkmate branded smartphone-paired breathalyzer

Commercial Smartphone-paired breathalyzers-Set 2
FloomeDEVICE

Floome branded smartphone-paired breathalyzer

Commercial Smartphone-paired breathalyzers-Set 2
Intoxilyzer 240DEVICE

Intoxilyzer 240 police grade breathalyzer

Commercial Smartphone-paired breathalyzers-Set 1Commercial Smartphone-paired breathalyzers-Set 2

Eligibility Criteria

Age21 Years - 39 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (21)

  • 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.

    PMID: 23279560BACKGROUND

  • 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.

    PMID: 10636603BACKGROUND

  • 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.

    PMID: 15907777BACKGROUND

  • 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.

    PMID: 18179312BACKGROUND

  • 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.

    PMID: 12724485BACKGROUND

  • 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.

    PMID: 18042920BACKGROUND

  • 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.

    PMID: 21373791BACKGROUND

  • 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.

    PMID: 23216417BACKGROUND

  • 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.

    PMID: 22690907BACKGROUND

  • 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.

    PMID: 9707655BACKGROUND

  • 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.

    PMID: 25569175BACKGROUND

  • 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.

    PMID: 12503979BACKGROUND

  • 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.

    PMID: 10669051BACKGROUND

  • 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.

    PMID: 10780125BACKGROUND

  • 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.

    PMID: 17034434BACKGROUND

  • 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.

    PMID: 17074952BACKGROUND

  • 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.

    PMID: 23596504BACKGROUND

  • 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.

    PMID: 24603444BACKGROUND

  • 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.

    PMID: 24913486BACKGROUND

  • 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.

    PMID: 7289599BACKGROUND

  • 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. doi: 10.35946/arcr.v35.2.11.

    PMID: 24881329BACKGROUND

MeSH Terms

Conditions

Alcohol DrinkingAlcoholic Intoxication

Condition Hierarchy (Ancestors)

Drinking BehaviorBehaviorAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Results Point of Contact

Title
Jessie Hemmons
Organization
University of Pennsylvania
jhemmons@pennmedicine.upenn.edu
215-746-8255

Study Officials

  • M. Kit Delgado, MD, MS

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2019

First Posted

September 11, 2019

Study Start

December 13, 2016

Primary Completion

April 17, 2017

Study Completion

April 17, 2017

Last Updated

October 20, 2020

Results First Posted

October 20, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share