Driving ImpairedNCT07282405
Validation of Alcohol Level Identification Using DRIVESC
A study testing DRIVESC and Alcohol in people with Driving Impaired, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Driving Impaired
- What is being tested?
- DRIVESC and Alcohol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2025to 4 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- DRIVESC, Alcohol
- Keywords
- drunk driving, alcohol
- Medical subject headings
- Driving Under the Influence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DRIVESCDiagnostic test
Also called fitness to drive tests
Fitness to Drive Screening test battery and computer cognitive tests to assess divided attention, reaction time, and working memory
AlcoholOther
Also called ethanol
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
| Study group | Role | What they receive |
|---|---|---|
| Alcohol Negative Day 1, Alcohol Negative Day 2 | Experimental | N = 6 participants, participants do not crossover Receives: 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 Receives: 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 Receives: Diagnostic Test: DRIVESC; Other: Alcohol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through day 2
Secondary outcomes (1)
Within-Participant Change in DRIVESC Composite Score from Day 1 to Day 2: Non-Drinking Arm
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.
Measured: through day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start11 Nov 2025
- Primary completion4 Feb 2026
- Study completion4 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Driving ImpairedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Non-blinded three arm partial crossover
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heather Barkholtz, PhD, Principal investigator, UW School of Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07282405
- Sponsor's protocol ID
- 2025-1470
- Other IDs
- Protocol Version 10/22/25, A561000
- Status last verified
- Feb 2026
- First submitted
- 2 Dec 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Alcohol Level Identification Using DRIVESC
- ClinicalTrials.gov ID
- NCT07282405
- Acronym / sponsor ID
- 2025-1470
- Conditions
- Driving Impaired
- Keywords
- drunk driving, alcohol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 11 Nov 2025 (actual)
- Primary completion
- 4 Feb 2026 (actual)
- Study completion
- 4 Feb 2026 (actual)
- First posted
- 15 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Non-blinded three arm partial crossover
| Arm | Type | Receives |
|---|---|---|
| Alcohol Negative Day 1, Alcohol Negative Day 2 | Experimental | Diagnostic Test: DRIVESCN = 6 participants, participants do not crossover |
| Alcohol Negative Day 1, Alcohol Positive Day 2 | Experimental | Diagnostic Test: DRIVESC, Other: AlcoholN = 6-9 participants, prior to dosing day, participants must demonstrate 0.00 grams / 210 liter breath alcohol |
| Alcohol Positive Day 1, Alcohol Negative Day 2 | Experimental | Diagnostic Test: DRIVESC, Other: AlcoholN = 6-9 participants, prior to dosing day, participants must demonstrate 0.00 grams / 210 liter breath alcohol |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DRIVESCAlso: fitness to drive testsFitness to Drive Screening test battery and computer cognitive tests to assess divided attention, reaction time, and working memory | Diagnostic test | Alcohol Negative Day 1, Alcohol Negative Day 2, Alcohol Negative Day 1, Alcohol Positive Day 2, Alcohol Positive Day 1, Alcohol Negative Day 2 |
| AlcoholAlso: ethanolparticipants 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 | Alcohol Negative Day 1, Alcohol Positive Day 2, Alcohol Positive Day 1, Alcohol Negative Day 2 |
Primary outcome
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.
1 secondary outcome
Within-Participant Change in DRIVESC Composite Score from Day 1 to Day 2: Non-Drinking Arm
Time frame: through day 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather Barkholtz, PhD principal investigator
UW School of Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DRIVESC and Alcohol in people with Driving Impaired, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Enrolled Participants who Complete all Scheduled Activities (time frame: through day 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.