Validation of Alcohol Level Identification Using DRIVESC

University of Wisconsin (UW)

Status: Invitation-only

Conditions: Driving Impaired

Treatments: Diagnostic Test: DRIVESC; Other: Alcohol

Study type: Interventional

Funder types: Other

Identifiers

NCT07282405

2025-1470

Protocol Version 10/22/25 (Other Identifier)

A561000 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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22 participants in 3 patient groups

Alcohol Negative Day 1, Alcohol Negative Day 2

Experimental group

Description:

N = 6 participants, participants do not crossover

Treatment:

Diagnostic Test: DRIVESC

Alcohol Negative Day 1, Alcohol Positive Day 2

Experimental group

Description:

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

Treatment:

Other: Alcohol

Diagnostic Test: DRIVESC

Alcohol Positive Day 1, Alcohol Negative Day 2

Experimental group

Description:

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

Treatment:

Other: Alcohol

Diagnostic Test: DRIVESC