NCT06975020

Pilot-Study for the Comparison of Biomarkers Between Regular Cannabis Users and Non-Users

CANBiome: Pilot-Study for the Comparison of Biomarkers Between Regular Cannabis Users and Non-Users

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: University of Basel · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The relevance of driving under the influence of cannabis is becoming increasingly important in the context of legalization. However, the measurement of tetrahydrocannabinol (THC) blood concentration is an inadequate marker for assessing driving impairment. Currently, there is no reliable marker available for estimating the time of last cannabis inhalation, which would provide a promising tool for regulating driving under the influence of cannabis. This pilot study aims to explore potential biomarkers and factors that could approximate the timing of the last cannabis inhalation, with emphasis on the potential explanation of interindividual differences in THC pharmacokinetics and -dynamics. The results will assist future research aimed at improving the ability to distinguish between impaired and unimpaired cannabis users in road traffic. These findings are of significant importance for road safety and for society at large, as they may provide more objective markers for cannabis inhalation, thereby permitting a methodologically sound evaluation of driving under the influence of cannabis.

Conditions

• Driving Under the Influence of Cannabis

Interventions

Type	Name	Description
DRUG	Participants will prepare their cannabis product ad libitum and inhale the prepared product as usual for a maximum of 15 minutes.	Participants will prepare and inhale their cannabis product ad libitum for a maximum of 15 minutes. Prior to inhaling cannabis (the baseline), and for three hours thereafter, biological samples (e.g., blood) will be collected. Participants will be asked to complete a series of questionnaires addressing their (subjective) neurocognitive function and well-being, as well as their self-rated driving ability and subjective cannabis effects.

Timeline

• Start date: 2025-12-19
• Primary completion: 2026-12-31
• Completion: 2027-01-01
• First posted: 2025-05-16
• Last updated: 2025-12-26

Locations

1 site across 1 country: Switzerland