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Completed

NCT Number: NCT05028413

Evaluating Perceived Fitness to Drive While Intoxicated

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.

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Key information

Conditions

Alcohol Drinking Alcohol Intoxication Alcohol-Related Disorders Alcoholic Intoxication Behavior Chemically-Induced Disorders Criminal Behavior Dangerous Behavior Drinking Behavior Drinking, Alcohol Driving Under the Influence Mental Disorders Perception, Self Substance-Related Disorders

Age range

21 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Participants Shown their Breath Alcohol Content Measurement

Behavioral

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 outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Aug 31, 2021
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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