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Completed

NCT Number: NCT07282405

Validation of Alcohol Level Identification Using DRIVESC

This pilot study will evaluate the feasibility and acceptability of using a commercially available DRIVESC fitness-to-drive measurement tool to detect alcohol-induced impairment in healthy adult participants. The investigators hypothesize that DRIVESC can detect measurable changes in driving-related cognitive and motor performance across blood alcohol concentrations up to the U.S. per se legal limit of 0.08% g/210L ethanol. The study will enroll healthy adults aged 18-64 years (including both dosed and zero-alcohol arms) participating in the Wisconsin Breath Alcohol Examiner Specialist course, with each participant completing two study visits over two days.

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Key information

Conditions

Driving Impaired Behavior Criminal Behavior Dangerous Behavior Driving Under the Influence

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin

Madison, Wisconsin, 53792, United States

About this study

A total of 18-22 participants will be enrolled in this single-site partial crossover pilot study. Under the auspices of the Wisconsin Basic Breath Examiner Specialist training, participants will be dosed with alcohol on the first, second, or neither day of the three-day training.

This study design includes 6 double-alcohol-negative participants who will complete two days of alcohol-negative study tasks. The investigators will consider enrolling 12 alcohol-positive participants a success but are aiming to enroll 16 alcohol-positive participants. Alcohol-positive participants will complete two days of study tasks where one day is alcohol-negative and the other day is alcohol-positive. The order of positive-negative and negative-positive will be balanced. This range allows for flexibility in this feasibility study as study activities are scheduled in coordination with and around Chemical Testing Section training activities to minimize disruption to their educational tasks.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Participants will be included in this study if they are trainees, observers, or instructors in the Wisconsin Basic Breath Examiner Specialist training program
  • Meet the age requirements for their assigned study arm (18 years or older for non-drinking, 21 years or older for drinking), and
  • Are able to provide informed consent.

Exclusion criteria

  • Participants will be excluded from this study if they are unable to provide informed consent
  • Do not meet the age requirements for their assigned study arm, or
  • Are determined to be not suitable for participation due to other reasons at the discretion of the study team.

Treatment and study plan

DRIVESC

Diagnostic Test

Fitness to Drive Screening test battery and computer cognitive tests to assess divided attention, reaction time, and working memory

Other names: fitness to drive tests

Alcohol

Other

participants are dosed as part of the Wisconsin Basic Breath Examiner Specialist Training offered by the Chemical Testing Section (and not by the study team) over a one-hour period to a breath alcohol up to the legal limit of 0.08 percent grams/210 liter ethanol

Other names: ethanol

Primary outcomes

  1. Proportion of Enrolled Participants who Complete all Scheduled Activities

    Time frame: through day 2

    Data will be recorded as completed vs not completed measurements or timepoints for each participant session.

Secondary outcomes

  1. Within-Participant Change in DRIVESC Composite Score from Day 1 to Day 2: Non-Drinking Arm

    Time frame: through day 2

    The DRIVESC composite scoring is proprietary, but creates a single score representative of an individual's fitness to drive. It is calculated by combining the individual's performance on different cognitive and psychomotor assessments including measures of resilience, short-term memory recall, reaction ability, and completion of divided attention tasks. Scores range from 0-1 where 1 is the highest fitness to drive.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 15, 2025
Registry last updated
Feb 27, 2026

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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