Validation of Alcohol Level Identification Using DRIVESC

NCT ID: NCT07282405

Last Updated: 2025-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-11

Study Completion Date

2026-03-31

Brief Summary

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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

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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

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Driving Impaired

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Non-blinded three arm partial crossover
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Alcohol Negative Day 1, Alcohol Negative Day 2

N = 6 participants, participants do not crossover

Group Type EXPERIMENTAL

DRIVESC

Intervention Type DIAGNOSTIC_TEST

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

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

Group Type EXPERIMENTAL

DRIVESC

Intervention Type DIAGNOSTIC_TEST

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

Alcohol

Intervention Type 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

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

Group Type EXPERIMENTAL

DRIVESC

Intervention Type DIAGNOSTIC_TEST

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

Alcohol

Intervention Type 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

Interventions

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DRIVESC

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

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type OTHER

Other Intervention Names

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fitness to drive tests ethanol

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Heather Barkholtz, PhD

Role: PRINCIPAL_INVESTIGATOR

UW School of Pharmacy

Locations

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University of Wisconsin

Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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Protocol Version 10/22/25

Identifier Type: OTHER

Identifier Source: secondary_id

A561000

Identifier Type: OTHER

Identifier Source: secondary_id

2025-1470

Identifier Type: -

Identifier Source: org_study_id

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