Actively Recruiting
Pilot-Study for the Comparison of Biomarkers Between Regular Cannabis Users and Non-Users
Led by University of Basel · Updated on 2025-12-26
120
Participants Needed
1
Research Sites
54 weeks
Total Duration
On this page
Sponsors
U
University of Basel
Lead Sponsor
U
University Psychiatric Clinics Basel
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Pilot-Study for the Comparison of Biomarkers Between Regular Cannabis Users and Non-Users
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Experience of smoking cannabis products on average once a week, including possible combination with tobacco
- Age between 18 and 65 years
- Possession of a 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 use on the study day
- No alcohol consumption within the last 24 hours
You will not qualify if you...
- Participation in a trial with investigational drugs within 30 days
- Current or previous major psychiatric disorders such as major depression or schizophrenia spectrum disorder
- Pregnancy or breastfeeding
- Use of CYP2C9, CYP2C19, or CYP3A4 inducers or inhibitors within 4 weeks before the study, including specific antibiotics, anticonvulsants, antiarrhythmics, antifungals, protease inhibitors, or grapefruit juice
- Presence of vasopressin deficiency, pituitary tumor, active malignancy, severe hyponatremia requiring treatment, congestive heart failure, or liver cirrhosis
AI-Screening
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Trial Site Locations
Total: 1 location
1
Insitute of forensic medicine
Basel, Switzerland, 4056
Actively Recruiting
Research Team
U
Urs Duthaler, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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