NCT07282405

Validation of Alcohol Level Identification Using DRIVESC

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Driving Impaired

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	DRIVESC	Fitness to Drive Screening test battery and computer cognitive tests to assess divided attention, reaction time, and working memory
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

Timeline

• Start date: 2025-11-11
• Primary completion: 2026-02-04
• Completion: 2026-02-04
• First posted: 2025-12-15
• Last updated: 2026-02-27

Locations

1 site across 1 country: United States