INTERVENTIONALRECRUITINGNCT06975020

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

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.

Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2025-12-26

What this record can show

Protocol only - no registry results posted

This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.

Registry facts

Study at a glance

Phase: NA
Enrollment: 120 (ESTIMATED)
Start date: 2025-12-19
Sponsor: University of Basel
Design: NON RANDOMIZED · SEQUENTIAL · BASIC SCIENCE
Locations: 1
Results record: Not present in registry snapshot

Linked local records

Related local records

Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.

Conditions

No published condition report matched.

Cannabinoids and active compounds

No governed compound link was found.

Medicines

No exact medicine-name link was found.

Research network

Researchers and organizations

Anya Umlauf Breland E. Smith David J. Grelotti David Meiri Dzmitry Mukha Emily G. Sones Gil Lewitus Igor Grant Jacqueline A. Hubbard JOAN SEVERSON

secondary measures

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 months

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 months

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 months

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 months

Analysis of the protein-bound and free fractions of the different cannabinoids and their metabolites using e.g. equilibrium dialysis or ultracentrifugation

Time frame: 24 months

Targeted and untargeted analysis of endogenous biomarkers (e.g. endocannabinoids) using e.g. high-resolution mass-spectrometry

Time frame: 24 months

Subjectively experienced effects of cannabis inhalation (e.g. subjective driving ability, psychological effects and well-being) assessed by questionnaires (e.g. VAS)

Time frame: 24 months

The effects of cannabis inhalation on neurocognition by non-invasive, neurocognitive testing

Time frame: 24 months

Self-reported mood as measured e.g. by the Bf-SR questionnaire.

Time frame: 24 months

Usual reasons for cannabis use as measured e.g. by the Marijuana Motives Questionnaire (MMQ)

Time frame: 24 months

Measurement of hormones and biomarkers involved in the regulation of fluid balance (e.g. plasma osmolality …)

Time frame: 24 months

Measurement of hormones and biomarkers of the anterior and posterior pituitary gland (e.g., plasma oxytocin, neurophysin I, ACTH, TSH, prolactin …)

Time frame: 24 months

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

Protocol only - no registry results posted

Study at a glance

Related local records

Conditions

Cannabinoids and active compounds

Medicines

Researchers and organizations

What was registered

Participants will prepare their cannabis product ad libitum and inhale the prepared product as usual for a maximum of 15 minutes.

Population and criteria

Inclusion criteria

Exclusion criteria

primary measures

Quantification of phytochemicals in cannabis sativa (e.g. cannabinoids and flavonoids) and their metabolites in human whole blood samples.

secondary measures

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

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

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)

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

Analysis of the protein-bound and free fractions of the different cannabinoids and their metabolites using e.g. equilibrium dialysis or ultracentrifugation

Targeted and untargeted analysis of endogenous biomarkers (e.g. endocannabinoids) using e.g. high-resolution mass-spectrometry

Subjectively experienced effects of cannabis inhalation (e.g. subjective driving ability, psychological effects and well-being) assessed by questionnaires (e.g. VAS)

The effects of cannabis inhalation on neurocognition by non-invasive, neurocognitive testing

Self-reported mood as measured e.g. by the Bf-SR questionnaire.

Usual reasons for cannabis use as measured e.g. by the Marijuana Motives Questionnaire (MMQ)

Measurement of hormones and biomarkers involved in the regulation of fluid balance (e.g. plasma osmolality …)

Measurement of hormones and biomarkers of the anterior and posterior pituitary gland (e.g., plasma oxytocin, neurophysin I, ACTH, TSH, prolactin …)

Locally readable linked articles

Driving Performance and Cannabis Users' Perception of Safety: A Randomized Clinical Trial.

A new ESI-LC/MS approach for comprehensive metabolic profiling of phytocannabinoids in Cannabis.