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
This trial accepts healthy volunteersQualifiers
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
Design model
Sequential
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.
DrugParticipants 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.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Cannabis groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Quantification of phytochemicals in cannabis sativa (e.g. cannabinoids and flavonoids) and their metabolites in human whole blood samples.
Quantification of the blood concentration of cannabis sativa phytochemicals such as minor cannabinoids, cannabinoids, and flavonoids. Blood samples will be analyzed at baseline and several time-points (0, 10, 20, 60, 180) post consumption of cannabis. Concentrations will be reported as ng/mL whole blood.
Time frame
24 monthsSecondary outcomes
1
Measurement of the expression levels of relevant genes e.g. cannabinoid receptor 1 (CB1) and cannabinoid receptor 2 (CB2) in whole blood samples by e.g. RT-PCR to evaluate especially their correlation with cannabinoid plasma levels, metabolism, and ph
Time frame
24 months2
Assessment of selected genetic polymorphisms in the genes known to interact with cannabinoids (i.e. CYP2C9, CYP2C19) by e.g. RT-PCR to evaluate their influence on cannabinoid plasma levels and the ability to predict cannabinoid metabolism and pharmaco
Time frame
24 months3
Quantitation of biomarkers applicable to determine the activity of enzymes or transporters known to be involved in the handling of cannabinoids (e.g. 4-ß-hydroxycholesterol, Coproporphyrin I und Coproporphyrin III)
Time frame
24 months4
Comparison of DNA methylation profiles on blood-derived DNA samples between regular and non-cannabis users by evaluating key CpG sites (e.g., in the MCU gene) that interplay with risk factors and mental health by e.g. targeted Illumina DNA methylation
Time frame
24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
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