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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.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2026-07-20
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Registry facts
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Interventions
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).
Eligibility
primary outcomes
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.
secondary outcomes
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Publications
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