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Evaluating Perceived Fitness to Drive While Intoxicated

Primary Purpose

Alcohol Drinking, Alcohol Intoxication, Perception, Self

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Participants Shown their Breath Alcohol Content Measurement
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Alcohol Drinking

Eligibility Criteria

21 Years - 39 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Perelman Center for Advanced Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Participants Blinded to BrAC reading (Control)

Participants Aware of their BrAC reading

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Participants' Perceived Fitness to Drive Measurement
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

Participants' Perceived Willingness to Drive Measurement
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

Full Information

First Posted
August 24, 2021
Last Updated
January 31, 2022
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT05028413
Brief Title
Evaluating Perceived Fitness to Drive While Intoxicated
Official Title
Pilot Randomized Control Trial of Smartphone-enabled Breath Alcohol Monitoring on Perceived Fitness to Drive a Vehicle Among Intoxicated Adults
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
May 8, 2017 (Actual)
Primary Completion Date
June 23, 2017 (Actual)
Study Completion Date
June 23, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking, Alcohol Intoxication, Perception, Self, Drinking, Alcohol, Driving Under the Influence, Drinking Behavior

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Participants Blinded to BrAC reading (Control)
Arm Type
No Intervention
Arm Description
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.
Arm Title
Participants Aware of their BrAC reading
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Participants Shown their Breath Alcohol Content Measurement
Intervention Description
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.
Primary Outcome Measure Information:
Title
Participants' Perceived Fitness to Drive Measurement
Description
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
Time Frame
The duration of study visit, up to 8 hours
Secondary Outcome Measure Information:
Title
Participants' Perceived Willingness to Drive Measurement
Description
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
Time Frame
The duration of study visit, up to 8 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Perelman Center for Advanced Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18179312
Citation
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.
Results Reference
background
PubMed Identifier
15907777
Citation
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.
Results Reference
background
PubMed Identifier
23216417
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.
Results Reference
background
PubMed Identifier
22690907
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.
Results Reference
background
PubMed Identifier
8778124
Citation
Patton JH, Stanford MS, Barratt ES. Factor structure of the Barratt impulsiveness scale. J Clin Psychol. 1995 Nov;51(6):768-74. doi: 10.1002/1097-4679(199511)51:63.0.co;2-1.
Results Reference
background
PubMed Identifier
23596504
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.
Results Reference
background
Links:
URL
https://www.bactrack.com/products/bactrack-mobile-smartphone-breathalyzer
Description
BacTrack Mobile Smartphone Paired Breathalyzer

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Evaluating Perceived Fitness to Drive While Intoxicated

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