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Driving Under the InfluenceREVELIONCT07401628

In-Vehicle Real-Time Cannabis Influenced Driving Detection

A study testing Cannabis (THC) in people with Driving Under the Influence and Cannabis-impaired Driving, run by University of Bern at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this clinical trial is to evaluate whether in-vehicle sensor data can be used to detect cannabis-impaired driving in healthy adult recreational cannabis users. The study aims to assess whether changes in vehicle, driver, and physiological sensor data can distinguish sober driving from cannabis-impaired… Read more about this study

Who is it for?
Ages 21 years and olderHealthy volunteers can take part
What is being tested?
Cannabis (THC)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteSwitzerland
Study dates
5 Jan 2026to 14 Jul 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 21 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Informed consent as documented by signature
  • Recreational cannabis-consumption (more than once per month)
  • In possession of a definite Swiss or European Union (EU) driving license
  • At least 21 years old
  • Active, regular driving a car in the last 6 months
  • Must be in good health condition
  • No special equipment needed when driving (special seats, levers, etc.)
  • Fluent in (Swiss) German and no speech impairment

Who cannot join

  • Health concerns where cannabis consumption is contra-indicated (such as: high blood pressure, psychiatric problems (e.g. psychosis, depression, attention-deficit conditions, etc.)
  • Cannabis-abstinence or excessive consumption, , assessed using the Cannabis Use Disorders Identification Test-Revised (CUDIT-R)
  • For women: pregnancy or breastfeeding or if intention to become pregnant during study period (time between telephone screening and study day (visit 2)
  • Alcohol misuse or excessive alcohol consumption habits/risky drinking behaviour, assessed using the Alcohol Use Disorders Identification Test (AUDIT) and/or phosphatidylethanol (PEth) in capillary blood > 200 ng/mL at first visit
  • If breath alcohol test is positive at Visit 1 or Visit 2 (study day)
  • Consumption of drugs of abuse (others than cannabis) within 4 weeks before the study
  • Consumption of medications / pharmaceutical drugs which interfere with driving ability
  • Inability to follow the procedures of the study, e.g., due to language

Trial locations and contacts

1 site in 1 country.

Switzerland1 site
  • Institute for Forensic Medicine, Forensic Chemistry and Toxicology University of Bern

    Bern, 3008

Other trials in Switzerland

About this study

Official title: Randomised, Controlled, Interventional Single-center Study for the Design and Evaluation of an In-vehicle Real-time System for Detecting Cannabis-impaired Driving (CID)

The goal of this clinical trial is to evaluate whether in-vehicle sensor data can be used to detect cannabis-impaired driving in healthy adult recreational cannabis users.

The study aims to assess whether changes in vehicle, driver, and physiological sensor data can distinguish sober driving from cannabis-impaired driving, and how driving performance changes from baseline to approximately 1 to 6 hours after controlled cannabis consumption.

Read more

Researchers will compare driving behavior and in-vehicle sensor data from participants who receive controlled cannabis administration with data from a randomized reference group without cannabis exposure, to determine whether cannabis-related impairment driving can be identified on the basis of machine learning.

Participants will complete screening and baseline assessments and drive an instrumented vehicle on a closed test track under sober conditions. Participants assigned to the experimental arm will receive controlled cannabis administration, while participants in the reference arm will receive no intervention. All participants will perform repeated standardized driving sessions over several hours and complete traffic-medical, traffic-psychological, and in-vehicle pre-driving tests. Biological samples and in-vehicle sensor data will be collected throughout the study.

Being tested
Cannabis (THC)
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.

  • Cannabis (THC)Drug

    Participants assigned to the experimental arm receive a single, controlled inhalative administration of cannabis by smoking a THC-containing joint (target dose 0.67 mg THC per kg body weight; cannabis flowers with 15-18% THC).

Study groups in NCT07401628
Study groupRoleWhat they receive
Controlled Cannabis AdministrationExperimentalParticipants assigned to this arm receive a single, controlled inhalative administration of cannabis by smoking a THC-containing joint with a target dose of approximately 0.67 mg THC per kg body weight. Participants complete standardized driving sessions in an instrumented vehicle on a closed test track under sober baseline conditions and repeatedly after cannabis administration (approximately 1-6 hours post-dose). All driving sessions are conducted with a certified driving instructor seated in the front passenger seat with access to dual pedals, allowing immediate intervention if required. Multimodal in-vehicle sensor data, physiological signals, driving performance measures, and biological samples are collected throughout the study.
Receives: Drug: Cannabis (THC)
Reference (No Cannabis)No interventionParticipants assigned to this reference arm receive no cannabis administration. They complete the same screening procedures, standardized driving sessions, assessments, and data collection as the experimental group under sober conditions, following the same schedule and time points. All driving sessions are conducted with a certified driving instructor seated in the front passenger seat with access to dual pedals, ensuring identical safety conditions. This arm serves as a non-impaired reference for comparison of driving behavior and in-vehicle sensor data.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Diagnostic accuracy (AUROC) of a multimodal machine-learning model for detection of cannabis-impaired driving

    Area under the receiver operating characteristic curve (AUROC) of a single machine-learning classifier that integrates multimodal in-vehicle data (including vehicle controller area network [CAN] data, driver monitoring camera [DMC] features, and physiological signals). All modalities are combined into one predictive model, and performance is reported as one aggregated AUROC value distinguishing non-impaired (sober) driving from cannabis-impaired driving.

    Measured: Baseline (sober driving) and up to 6 hours after cannabis administration in the experimental arm, with matched time points in the reference arm.

Secondary outcomes (17)
  1. Diagnostic accuracy (AUROC) using CAN data

    AUROC for detecting cannabis-impaired driving using vehicle controller area network (CAN) data only.

    Measured: Baseline (sober driving) and approximately 1-2, 3-4, and 5-6 hours after cannabis administration in the experimental arm, with matched time points in the reference arm.

  2. Diagnostic accuracy (AUROC) using DMC data

    AUROC for detecting cannabis-impaired driving using driver monitoring camera (DMC) data only.

    Measured: Baseline (sober driving) and approximately 1-2, 3-4, and 5-6 hours after cannabis administration in the experimental arm, with matched time points in the reference arm.

  3. Diagnostic accuracy (AUROC) of a physiology-based machine-learning model for detection of cannabis-impaired driving

    AUROC of a single machine-learning classifier trained and evaluated using aggregated physiological features only, derived from signals including heart rate, heart-rate variability, oxygen saturation, electrodermal activity, skin temperature, and respiration-related measures. All physiological signals are combined into one predictive model, and performance is reported as a single AUROC value distinguishing non-impaired (sober) driving from cannabis-impaired driving.

    Measured: Baseline (sober driving) and approximately 1-2, 3-4, and 5-6 hours after cannabis administration in the experimental arm, with matched time points in the reference arm.

  4. Change in driving behavior derived from vehicle CAN data

    Change in driving behavior between sober driving and post-cannabis driving, derived from vehicle controller area network (CAN) signals, including steering, braking, acceleration, and velocity-related measures.

    Measured: Baseline (sober driving) and approximately 1-2, 3-4, and 5-6 hours after cannabis administration in the experimental arm, with matched time points in the reference arm.

  5. Change in driver gaze behavior derived from DMC data

    Change in gaze behavior between sober and post-cannabis driving, derived from driver monitoring camera (DMC) data, including gaze direction and gaze dynamics during driving.

    Measured: Baseline (sober driving) and approximately 1-2, 3-4, and 5-6 hours after cannabis administration in the experimental arm, with matched time points in the reference arm.

  6. Change in head movement behavior derived from DMC data

    Change in head movement behavior between sober and post-cannabis driving, derived from driver monitoring camera (DMC) data.

    Measured: Baseline (sober driving) and approximately 1-2, 3-4, and 5-6 hours after cannabis administration in the experimental arm, with matched time points in the reference arm.

  7. Driving instructor assessment of driving performance

    Assessment of driving performance conducted by a certified driving instructor, quantified as the number of safety interventions required during each standardized driving session.

    Measured: Baseline (sober driving) and approximately 1-2, 3-4, and 5-6 hours after cannabis administration in the experimental arm, with matched time points in the reference arm.

  8. Diagnostic accuracy (AUROC) of an in-vehicle pre-driving readiness test for detection of cannabis-impaired driving

    AUROC of a machine-learning (ML) classification model implementing a study-specific in-vehicle pre-driving readiness test. The test produces an ML-derived readiness score, computed from features derived from the pre-driving test (e.g., attention-related, reaction-time-related, and psychomotor-related features), and is used to classify driving sessions as sober versus post-cannabis.

    Measured: Baseline (sober driving) and approximately 1-2, 3-4, and 5-6 hours after cannabis administration in the experimental arm, with matched time points in the reference arm.

  9. Performance in the standardized Psytest assessment

    Performance in the standardized Psytest assessment (mobility version of the Test of Attentional Performance), administered under sober conditions and after cannabis consumption. Test performance is summarized using a standardized test score reflecting overall attentional and psychomotor performance relevant for driving.

    Measured: Baseline (sober driving) and approximately 1-2, 3-4, and 5-6 hours after cannabis administration in the experimental arm, with matched time points in the reference arm.

  10. Self-reported subjective effects

    Self-reported subjective effects assessed using study questionnaires, including subjective feeling of "high" and degree of sleepiness. Responses are recorded using a Likert scale ranging from 0 to 10, where 0 indicates "not at all" and 10 indicates "extremely." Higher scores indicate a worse outcome, reflecting stronger subjective drug effects and greater sleepiness.

    Measured: Baseline (sober driving) and approximately 1-2, 3-4, and 5-6 hours after cannabis administration in the experimental arm, with matched time points in the reference arm.

  11. Cannabinoid biomarker concentrations in biological samples

    Concentrations of Δ9-tetrahydrocannabinol (THC) measured in capillary blood, oral fluid, and breath samples.

    Measured: Baseline in all participants, and approximately 1-2, 3-4, and 5-6 hours after cannabis administration in the experimental arm.

  12. Incidence of adverse events

    Incidence of adverse events and serious adverse events recorded during all study visits.

    Measured: From the first study procedure (i.e. baseline assessment) to the end of the main study day (i.e. driving assessment) expected to be on average up to 6 hours.

  13. Change in heart rate during driving

    Change in heart rate measured during driving between sober conditions and post-cannabis conditions.

    Measured: Baseline (sober driving) and approximately 1-2, 3-4, and 5-6 hours after cannabis administration in the experimental arm, with matched time points in the reference arm.

  14. Change in oxygen saturation during driving

    Change in oxygen saturation measured during driving between sober conditions and post-cannabis conditions.

    Measured: Baseline (sober driving) and approximately 1-2, 3-4, and 5-6 hours after cannabis administration in the experimental arm, with matched time points in the reference arm.

  15. Change in electrodermal activity during driving

    Change in electrodermal activity measured during driving between sober conditions and post-cannabis conditions.

    Measured: Baseline (sober driving) and approximately 1-2, 3-4, and 5-6 hours after cannabis administration in the experimental arm, with matched time points in the reference arm.

  16. Change in skin temperature during driving

    Change in skin temperature measured during driving between sober conditions and post-cannabis conditions.

    Measured: Baseline (sober driving) and approximately 1-2, 3-4, and 5-6 hours after cannabis administration in the experimental arm, with matched time points in the reference arm.

  17. Change in respiration during driving

    Change in respiration measured during driving between sober conditions and post-cannabis conditions.

    Measured: Baseline (sober driving) and approximately 1-2, 3-4, and 5-6 hours after cannabis administration in the experimental arm, with matched time points in the reference arm.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2026
  2. Study start5 Jan 2026
  3. Primary completion14 Jul 2026
  4. Study completion14 Jul 2026

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07401628
Sponsor's protocol ID
2025-01590
Other IDs
2025
Acronym
REVELIO
Status last verified
Jul 2026
First submitted
22 Jan 2026
Last updated
20 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Deuber R, Bechny M, Heck C, Brugger J, Pfaffli M, Jovanova M, Fleisch E, Wortmann F, Weinmann W. Protocol for the REVELIO test-track pilot study: A randomised, controlled, single-centre trial in healthy recreational cannabis users investigating real-time in-vehicle detection of cannabis-impaired driving. PLoS One. 2026 Oct 1;21(10):e0349328. doi: 10.1371/journal.pone.0349328. eCollection 2026.

    PubMed 42821661

Questions about this trial

What is this clinical trial studying?

A study testing Cannabis (THC) in people with Driving Under the Influence and Cannabis-impaired Driving, run by University of Bern at 1 site in Switzerland.

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 8 inclusion and 8 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 20 Jul 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 Switzerland. 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?

Diagnostic accuracy (AUROC) of a multimodal machine-learning model for detection of cannabis-impaired driving (time frame: Baseline (sober driving) and up to 6 hours after cannabis administration in the experimental arm, with matched time points in the reference arm.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07401628, which also lists 1 linked publication.

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 20 Jul 2026.

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