Evaluating Perceived Fitness to Drive While Intoxicated

June 20, 2024 updated by: M. Kit Delgado, MD, University of Pennsylvania

Pilot Randomized Control Trial of Smartphone-enabled Breath Alcohol Monitoring on Perceived Fitness to Drive a Vehicle Among Intoxicated Adults

The goal of this study is to conduct a laboratory-based pilot randomized control trial of smartphone-enabled breath alcohol monitoring on perceived fitness to drive a vehicle among intoxicated adults. The study team will enroll up to 30 adults aged > 21-44 who are frequent drinkers without dependence who drive more than four times per week to complete a standardized alcohol drinking protocol in a monitored setting collecting breathalyzer measurements. The protocol involves consuming three weight-based doses of alcohol with a target BAC of 0.10 and completing breathalyzer measurements every 20 minutes until a BAC of 0.03 is reached. The control group will complete a visual analog scale on their perceived fitness to drive and be blinded to their breath alcohol readings with the BACtrack Mobile Pro breathalyzer device, while the intervention group would do the same, but be shown their breath alcohol readings on the paired BACtrack smartphone application. The research team's previous research has validated the accuracy of the BACtrack Mobile Pro device to measure BAC within +/- 0.001 of police-grade breathalyzer and estimate BAC within +/- 0.01 of a blood test.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Perelman Center For Advanced Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 39 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age 21-39 years old,
  • Less than 4 drinking days and less than 12 drinks per week on average in the past 2 months,
  • Have consumed at least 4 (women) or 5 (men) drinks on one occasion, in the past year without experiencing adverse effects
  • Have a valid photo ID
  • Willing and able to use a rideshare credit or septa token as transportation home from the study visit
  • Drives at least 2 days per week on average.

Exclusion Criteria:

  • Desire alcohol treatment now or received it in the past 6 months,
  • Have Alcohol use disorder per DSM-V criteria
  • Meet or have met criteria for a substance use disorder within the past 12 months per DSM V criteria
  • Have a prior psychiatric condition requiring hospitalization
  • Are non-English-speaking
  • Individuals who have a medical condition or who are taking medication which limits or prevents the consumption of alcohol
  • Are experiencing suicidal ideation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Participants Blinded to BrAC reading (Control)
Participants randomized to this arm will consume three weight-based doses of alcohol with a target BAC of 0.10 and comple breathalyzer measurements every 20 minutes until a BAC of 0.03 is reached. They will complete a visual analog scale (the Self-Reported intoxication Survey) on their perceived fitness to drive and be blinded to their breath alcohol readings with the BACtrack Mobile Pro device.
Experimental: Participants Aware of their BrAC reading
Participants randomized to this arm will consume three weight-based doses of alcohol with a target BAC of 0.10 and comple breathalyzer measurements every 20 minutes until a BAC of 0.03 is reached. They will be shown their breath alcohol readings with the BACtrack Mobile Pro device before completing a visual analog scale (the Self-Reported intoxication Survey) on their perceived fitness to drive.
Behavioral: Participants Shown their Breath Alcohol Content Measurement
Each time a Breath Alcohol Content (BrAC) Measurement is taken by the research team, the participant is shown the measurement before completing the paper visual analog scale scale (the Self-Reported intoxication Survey) on their perceived fitness to drive.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participants' Perceived Fitness to Drive Measurement
Time Frame: The duration of study visit, up to 8 hours
Participant's self rating on visual analog scale from 1-10 (1: Extremely Able to Drive; 10: Not at all Able to Drive) after Breath Alcohol Content Measurement was collected
The duration of study visit, up to 8 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participants' Perceived Willingness to Drive Measurement
Time Frame: The duration of study visit, up to 8 hours
Participant's self rating on visual analog scale from 1-10 (1: Not at all Willing to Drive; 10: Extremely Willing to Drive) after Breath Alcohol Content Measurement was collected
The duration of study visit, up to 8 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 8, 2017

Primary Completion (Actual)

June 23, 2017

Study Completion (Actual)

June 23, 2017

Study Registration Dates

First Submitted

August 24, 2021

First Submitted That Met QC Criteria

August 30, 2021

First Posted (Actual)

August 31, 2021

Study Record Updates

Last Update Posted (Actual)

October 1, 2024

Last Update Submitted That Met QC Criteria

June 20, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 827284

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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