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.
Who can participate
Age range
21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Diagnostic accuracy (AUROC) of a multimodal machine-learning model for detection of cannabis-impaired driving
Timeframe: Baseline (sober driving) and up to 6 hours after cannabis administration in the experimental arm, with matched time points in the reference arm.