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

NCT ID: NCT06975020

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-19

Study Completion Date

2027-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Driving Under the Influence of Cannabis

Keywords

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Cannabis Driving Biomarker

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Cannabis group

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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.

Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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
* No alcohol consumption within the last 24 h

Exclusion Criteria

* 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.
* The following conditions: vasopressin deficiency, pituitary tumor, active malignancy, severe hyponatremia requiring treatment, congestive heart failure, liver cirrhosis.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Psychiatric Clinics Basel, University of Basel, Basel, Switzerland

UNKNOWN

Sponsor Role collaborator

Department of Endocrinology, Diabetology and Metabolism, University Hospital Basel, Basel, Switzerland

UNKNOWN

Sponsor Role collaborator

Biopharmacy, Department of Pharmaceutical Sciences, University of Basel, Basel, Switzerland

UNKNOWN

Sponsor Role collaborator

Institute of Forensic Medicine, University of Basel, Basel, Switzerland

UNKNOWN

Sponsor Role collaborator

University of Basel

OTHER

Sponsor Role lead

Responsible Party

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Urs Duthaler

PD Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Insitute of forensic medicine

Basel, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Urs Duthaler, PhD

Role: CONTACT

Phone: +41612673889

Email: [email protected]

Facility Contacts

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Urs Philipp Duthaler, PhD

Role: primary

References

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Kraemer M, Madea B, Hess C. Detectability of various cannabinoids in plasma samples of cannabis users: Indicators of recent cannabis use? Drug Test Anal. 2019 Oct;11(10):1498-1506. doi: 10.1002/dta.2682. Epub 2019 Sep 1.

Reference Type BACKGROUND
PMID: 31407526 (View on PubMed)

Berman P, Futoran K, Lewitus GM, Mukha D, Benami M, Shlomi T, Meiri D. A new ESI-LC/MS approach for comprehensive metabolic profiling of phytocannabinoids in Cannabis. Sci Rep. 2018 Sep 24;8(1):14280. doi: 10.1038/s41598-018-32651-4.

Reference Type BACKGROUND
PMID: 30250104 (View on PubMed)

Manthey J, Freeman TP, Kilian C, Lopez-Pelayo H, Rehm J. Public health monitoring of cannabis use in Europe: prevalence of use, cannabis potency, and treatment rates. Lancet Reg Health Eur. 2021 Sep 24;10:100227. doi: 10.1016/j.lanepe.2021.100227. eCollection 2021 Nov.

Reference Type BACKGROUND
PMID: 34806072 (View on PubMed)

Marcotte TD, Umlauf A, Grelotti DJ, Sones EG, Sobolesky PM, Smith BE, Hoffman MA, Hubbard JA, Severson J, Huestis MA, Grant I, Fitzgerald RL. Driving Performance and Cannabis Users' Perception of Safety: A Randomized Clinical Trial. JAMA Psychiatry. 2022 Mar 1;79(3):201-209. doi: 10.1001/jamapsychiatry.2021.4037.

Reference Type BACKGROUND
PMID: 35080588 (View on PubMed)

Other Identifiers

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2025-00354

Identifier Type: -

Identifier Source: org_study_id