Evaluating Perceived Fitness to Drive While Intoxicated

Sponsor
University of Pennsylvania (Other)
Overall Status
Completed
CT.gov ID
NCT05028413
Collaborator
(none)
20
1
2
1.5
13.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Participants Shown their Breath Alcohol Content Measurement
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Pilot Randomized Control Trial of Smartphone-enabled Breath Alcohol Monitoring on Perceived Fitness to Drive a Vehicle Among Intoxicated Adults
Actual Study Start Date :
May 8, 2017
Actual Primary Completion Date :
Jun 23, 2017
Actual Study Completion Date :
Jun 23, 2017

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Participants' Perceived Fitness to Drive Measurement [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 each Breath Alcohol Content Measurement collected

Secondary Outcome Measures

  1. Participants' Perceived Willingness to Drive Measurement [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 each Breath Alcohol Content Measurement collected

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 39 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Perelman Center for Advanced Medicine Philadelphia Pennsylvania United States 19104

Sponsors and Collaborators

  • University of Pennsylvania

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
M. Kit Delgado, MD, Assistant Professor of Emergency Medicine and Epidemiology, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT05028413
Other Study ID Numbers:
  • 827284
First Posted:
Aug 31, 2021
Last Update Posted:
Feb 15, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 15, 2022