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

University of Bern

Status: Enrolling

Conditions: Driving Under the Influence; Cannabis-impaired Driving

Treatments: Drug: Cannabis (THC)

Study type: Interventional

Funder types: Other

Identifiers

NCT07401628

2025-01590

Details and patient eligibility

About

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.

Enrollment: 45 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 2 patient groups

Controlled Cannabis Administration

Experimental group

Description:

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.

Treatment:

Drug: Cannabis (THC)

Reference (No Cannabis)

No Intervention group

Description:

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.