Validation of Alcohol Level Identification Using DRIVESC

February 23, 2026 updated by: University of Wisconsin, Madison
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Alcohol Negative Day 1, Alcohol Negative Day 2
N = 6 participants, participants do not crossover
Diagnostic test: DRIVESC
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
Experimental: Alcohol Negative Day 1, Alcohol Positive Day 2
N = 6-9 participants, prior to dosing day, participants must demonstrate 0.00 grams / 210 liter breath alcohol
Diagnostic test: DRIVESC
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
Other: Alcohol
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
Experimental: Alcohol Positive Day 1, Alcohol Negative Day 2
N = 6-9 participants, prior to dosing day, participants must demonstrate 0.00 grams / 210 liter breath alcohol
Diagnostic test: DRIVESC
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
Other: Alcohol
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through day 2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through day 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Investigators

  • Principal Investigator: Heather Barkholtz, PhD, UW School of Pharmacy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2025

Primary Completion (Actual)

February 4, 2026

Study Completion (Actual)

February 4, 2026

Study Registration Dates

First Submitted

December 2, 2025

First Submitted That Met QC Criteria

December 2, 2025

First Posted (Actual)

December 15, 2025

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 23, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-1470
  • A561000 (Other Identifier: UW Madison)
  • Protocol Version 10/22/25 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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