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Influence of Genetics on the Degradation of Cannabinoids

Genetic Influence of CYP2C9 Polymorphism on Pharmacokinetics of intravenously applied d-9-Tetrahydrocannabinol (THC) in Healthy Volunteers

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN53019164
Enrollment
30
Registered
2010-04-14
Start date
2010-03-01
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pharmacokinetics, Forensic Medicine, Anesthesiology Other

Interventions

300 healthy volunteers will be genetically screened for single nucleotide polymorphisms (SNP) in the Cytochrome P450 2C9 (CYP2C9) gene. The three alleles identified for this study will be 1. Wild Typ
11 12 13 22 23 33. Each group consists of about 5 people, although there may be some differences due to allelic frequencies. We will not study more than 30 volunteers. If more than 5 persons in a spec

Sponsors

Inselspital (Switzerland)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Healthy volunteers 2. 18-65 years old

Exclusion criteria

Exclusion criteria: 1. Refusal to participate 2. Does not speak or read German 3. Ongoing smoking status (<3 months since quitting) 4. Extreme nutritive status (BMI outside 16-35) 5. American Society of Anesthesiologists Status Class III and above 6. Suspected coronary heart disease 7. Major heart rhythm disturbances 8. Liver enzymes P450 altering medication 9. Any treated or suspected psychiatric diseases at any time during lifetime. This includes, but is not restricted to schizophrenic disorders, depression, use of heroin, cocaine, LSD, and ongoing use of THC (<1 month since quitting). 10. Pregnant, women will be tested by urine Human Chorionic Gonadotropin (HCG)-stick

Design outcomes

Primary

MeasureTime frame
Blood levels of THC and degradation products, assessed by blood sampling at baseline, and 1, 2, 5, 10, 15, 20, 30, 45, 60, 90, 180, 300 Minutes and 24h, 48h after THC injection.

Secondary

MeasureTime frame
1. Vitals 2. Side effects 3. Well being, assessed by questionnaires filled out at regular intervals as well by Visual Analogue Scale (VAS) 4. Pupillometry will obtained in a subgroup using standardised techniques

Countries

Switzerland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 6, 2026