In-Vehicle Real-Time Cannabis Influenced Driving Detection (REVELIO)

February 3, 2026 updated by: University of Bern

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Michal Bechny, Dr.
  • Phone Number: +41 76 221 62 56
  • Email: mbechny@ethz.ch

Study Locations

  • Switzerland
      • Bern, Switzerland, 3008
        • Recruiting
        • Institute for Forensic Medicine, Forensic Chemistry and Toxicology University of Bern
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Controlled Cannabis Administration
Participants 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.
Drug: Cannabis (THC)
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).
No Intervention: Reference (No Cannabis)
Participants 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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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.
Baseline (sober driving) and up to 6 hours after cannabis administration in the experimental arm, with matched time points in the reference arm.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy (AUROC) using CAN data
Time Frame: 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.
AUROC for detecting cannabis-impaired driving using vehicle controller area network (CAN) data only.
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.
Diagnostic accuracy (AUROC) using DMC data
Time Frame: 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.
AUROC for detecting cannabis-impaired driving using driver monitoring camera (DMC) data only.
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.
Diagnostic accuracy (AUROC) of a physiology-based machine-learning model for detection of cannabis-impaired driving
Time Frame: 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.
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.
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.
Change in driving behavior derived from vehicle CAN data
Time Frame: 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.
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.
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.
Change in driver gaze behavior derived from DMC data
Time Frame: 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.
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.
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.
Change in head movement behavior derived from DMC data
Time Frame: 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.
Change in head movement behavior between sober and post-cannabis driving, derived from driver monitoring camera (DMC) data.
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.
Driving instructor assessment of driving performance
Time Frame: 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.
Assessment of driving performance conducted by a certified driving instructor, quantified as the number of safety interventions required during each standardized driving session.
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.
Diagnostic accuracy (AUROC) of an in-vehicle pre-driving readiness test for detection of cannabis-impaired driving
Time Frame: 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.
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.
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.
Performance in the standardized Psytest assessment
Time Frame: 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.
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.
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.
Self-reported subjective effects
Time Frame: 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.
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.
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.
Cannabinoid biomarker concentrations in biological samples
Time Frame: Baseline in all participants, and approximately 1-2, 3-4, and 5-6 hours after cannabis administration in the experimental arm.
Concentrations of Δ9-tetrahydrocannabinol (THC) measured in capillary blood, oral fluid, and breath samples.
Baseline in all participants, and approximately 1-2, 3-4, and 5-6 hours after cannabis administration in the experimental arm.
Incidence of adverse events
Time Frame: 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.
Incidence of adverse events and serious adverse events recorded during all study visits.
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.
Change in heart rate during driving
Time Frame: 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.
Change in heart rate measured during driving between sober conditions and post-cannabis conditions.
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.
Change in oxygen saturation during driving
Time Frame: 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.
Change in oxygen saturation measured during driving between sober conditions and post-cannabis conditions.
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.
Change in electrodermal activity during driving
Time Frame: 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.
Change in electrodermal activity measured during driving between sober conditions and post-cannabis conditions.
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.
Change in skin temperature during driving
Time Frame: 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.
Change in skin temperature measured during driving between sober conditions and post-cannabis conditions.
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.
Change in respiration during driving
Time Frame: 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.
Change in respiration measured during driving between sober conditions and post-cannabis conditions.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Bern

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
ETH Zurich
University of St.Gallen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Wolfgang Weinmann, Prof. Dr., Institute for Forensic Medicine, Forensic Chemistry and Toxicology University of Bern

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 5, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 19, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 19, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 22, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025-01590

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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