Pilot-Study for the Comparison of Biomarkers Between Regular Cannabis Users and Non-Users
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Basel
About this trial
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.
Eligibility criteria
Qualifiers
Experience of smoking cannabis products, on average once a week. This may be in combination with tobacco.
Age 18-65 years Possession of driving license in at least one of the categories A, B, A1; B1, F, G or M
Sufficient knowledge of German
No cannabis inhalation or nicotine consumption on study day
Disqualifiers
Participation in a trial with investigational drugs within 30 days
Current or previous major psychiatric disorder (e.g., major depression, schizophrenia spectrum disorder)
Pregnancy or breastfeeding
Intake of CYP2C9, CYP2C19, and CYP3A4-inducers in the last 4 weeks before the study visit, e.g. rifampicin (antibiotic), carbamazepine (anticonvulsant), phenobarbital (anticonvulsant), phenytoin (anticonvulsant) or inhibitors, such as amiodarone (class III antiarrhythmic medication), antifungal drugs such as fluconazole, miconazole, voriconazole and itraconazole, antibiotics such as clarithromycin and sulfamethoxazole, ritonavir (protease inhibitor) and grapefruit juice.
Trial design
Treatments tested in this trial
- Participants will prepare their cannabis product ad libitum and inhale the prepared product as usual for a maximum of 15 minutes.
Treatment groups
120 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Basel
Lead sponsor
University Psychiatric Clinics Basel
Collaborator
Department of Endocrinology, Diabetology and Metabolism, University Hospital Basel, Basel, Switzerland
Collaborator
Biopharmacy, Department of Pharmaceutical Sciences, University of Basel, Basel, Switzerland
Collaborator
Institute of Forensic Medicine, University of Basel, Basel, Switzerland
Collaborator
Source ClinicalTrials.gov