Validation of Alcohol Level Identification Using DRIVESC

NCT07282405 | Completed

• 3 other identifiers: 2025-1470Protocol Version 10/22/25A561000
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Driving Impaired

Keywords

drunk driving; alcohol

Outcome Measures

Primary Outcomes (1)

• Proportion of Enrolled Participants who Complete all Scheduled Activities

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

  through day 2

Secondary Outcomes (1)

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

  through day 2

Study Arms (3)

Alcohol Negative Day 1, Alcohol Negative Day 2

EXPERIMENTAL

N = 6 participants, participants do not crossover

Diagnostic Test: DRIVESC

Alcohol Negative Day 1, Alcohol Positive Day 2

EXPERIMENTAL

N = 6-9 participants, prior to dosing day, participants must demonstrate 0.00 grams / 210 liter breath alcohol

Diagnostic Test: DRIVESC; Other: Alcohol

Alcohol Positive Day 1, Alcohol Negative Day 2

EXPERIMENTAL

N = 6-9 participants, prior to dosing day, participants must demonstrate 0.00 grams / 210 liter breath alcohol

Diagnostic Test: DRIVESC; Other: Alcohol

Interventions

DRIVESC DIAGNOSTIC_TEST

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

Also known as: fitness to drive tests

Alcohol Negative Day 1, Alcohol Negative Day 2; Alcohol Negative Day 1, Alcohol Positive Day 2; Alcohol Positive Day 1, Alcohol Negative Day 2

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

Also known as: ethanol

Alcohol Negative Day 1, Alcohol Positive Day 2; Alcohol Positive Day 1, Alcohol Negative Day 2

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Driving Under the Influence

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Criminal Behavior; Behavior; Dangerous Behavior

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Heather Barkholtz, PhD

  UW School of Pharmacy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Non-blinded three arm partial crossover

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 15, 2025
• Study Start: November 11, 2025
• Primary Completion: February 4, 2026
• Study Completion: February 4, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)