Breathalyzer Validation Study

Alcohol Drinking Clinical Trial

— BVS  

Official title:

Reducing Risky Drinking Using Smartphone Paired Breathalyzer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04086576
• Other study ID #: 825273
• Status: Completed
• Phase: N/A
• Start date: December 13, 2016
• Est. completion date: April 17, 2017

Study information

• Verified date: September 2020
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 17, 2017
• Est. primary completion date: April 17, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 39 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Intoxication
• Alcoholic Intoxication

Intervention

Device:
• Alcohoot
Alcohoot branded smartphone-paired breathalyzer
• BACtrack Mobile Pro
BACtrack Mobile Pro branded smartphone-paired breathalyzer
• DRIVESAFE Evoc
DRIVESAFE Evoc branded smartphone-paired breathalyzer
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

References & 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. — View Citation

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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. — View Citation

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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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. Review. — View 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. Review. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. Review. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	8 Hours
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	8 Hours