Evaluating Perceived Fitness to Drive While Intoxicated

Not Applicable

Completed

• Conditions: Drinking, Alcohol; Drinking Behavior; Alcohol Intoxication; Driving Under the Influence; Alcohol Drinking; Perception, Self
• Interventions: Behavioral: Participants Shown their Breath Alcohol Content Measurement

• Registration Number: NCT05028413
• Lead Sponsor: University of Pennsylvania

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-05-08
• Primary Completion: 2017-06-23
• Study Completion: 2017-06-23
• Study First Submitted: 2021-08-24
• Study First Submitted QC: 2021-08-30
• Study First Posted: 2021-08-31
• Results First Submitted: 2023-12-11
• Status Verified: 2024-06
• Results First Submitted QC: 2024-06-20
• Last Update Submitted: 2024-06-20
• Results First Posted: 2024-09-30
• Last Update Posted: 2024-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Participants Aware of their BrAC reading	Participants Shown their Breath Alcohol Content Measurement	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.

Primary Outcome Measures

Name	Time	Method
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 Breath Alcohol Content Measurement was collected

Secondary Outcome Measures

Name	Time	Method
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 Breath Alcohol Content Measurement was collected

Trial Locations

Locations (1)

Perelman Center for Advanced Medicine; 🇺🇸 Philadelphia, Pennsylvania, United States