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Breathalyzer Validation Study (BVS)

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ClinicalTrials.gov Identifier: NCT04086576
Recruitment Status : Completed
First Posted : September 11, 2019
Last Update Posted : September 11, 2019
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

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: Smartphone-paired mobile breathalyzer Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
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 : December 13, 2016
Actual Primary Completion Date : April 17, 2017
Actual Study Completion Date : April 17, 2017

Arm Intervention/treatment
Experimental: Commercial Smartphone-paired breathalyzers
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: Smartphone-paired mobile 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: 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.




Primary Outcome Measures :
  1. Blood Alcohol Content Variability [ Time Frame: 8 Hours ]
    Mean paired-difference between the peak BrAC and phlebotomy drawn BAC among the police-grade and personal breath testing devices


Secondary Outcome Measures :
  1. Differences in Breathlyzer Readings [ Time Frame: 8 Hours ]
    Mean difference in BrAC between the police-grade and personal breath testing devices


Other Outcome Measures:
  1. Driving Limit Threshold Detection [ Time Frame: 8 Hours ]
    The sensitivity to detect driving-limit thresholds of > 0.05% and > 0.08% relative to the police-grade breath testing devices



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 39 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04086576


Sponsors and Collaborators
University of Pennsylvania
Investigators
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Principal Investigator: M. Kit Delgado, MD, MS University of Pennsylvania

Publications:

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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT04086576    
Other Study ID Numbers: 825273
First Posted: September 11, 2019    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Alcoholic Intoxication
Alcohol Drinking
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders