Influence of Genetics on the Degradation of Cannabinoids
| ISRCTN | ISRCTN53019164 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN53019164 |
| Secondary identifying numbers | THLD2010-1 |
- Submission date
- 22/02/2010
- Registration date
- 14/04/2010
- Last edited
- 06/06/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Lorenz Theiler
Scientific
Scientific
University Dept of Anesthesiology and Pain Therapy
Inselspital
Bern
3010
Switzerland
| ltheiler@med.miami.edu |
Study information
| Study design | Single centre open label uncontrolled interventional pharmacokinetic study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cohort study |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details below to request a patient information sheet |
| Scientific title | Genetic Influence of CYP2C9 Polymorphism on Pharmacokinetics of intravenously applied d-9-Tetrahydrocannabinol (THC) in Healthy Volunteers |
| Study objectives | Rate of intravenous applied d-9THC depends on genetically determined CYP2C9, where two polymorphisms (SNP) are known |
| Ethics approval(s) | Cantonal Ethics Committee of Bern approved on the 22nd of February 2010 (ref: KEK-Number 241/09) |
| Health condition(s) or problem(s) studied | Pharmacokinetics, Forensic Medicine, Anesthesiology |
| Intervention | 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 Type (WT) 2. R144C 3. I359L 30 volunteers will be picked to form 6 groups will be based on the 6 possible allelic combinations; 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 specific group are available from the screened population (that is expected for the WT), than we will randomly choose by computer randomisation. Participants will receive a single dose of 0.1mg/kg intravenous (IV) THC. Vitals and blood THC levels will be measured continuously for 72 hours. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | d-9-Tetrahydrocannabinol (THC) |
| Primary outcome measure | 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 outcome measures | 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 |
| Overall study start date | 01/03/2010 |
| Completion date | 01/07/2010 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | Screening: 300, Inclusion in Study: 30 |
| Key inclusion criteria | 1. Healthy volunteers 2. 18-65 years old |
| Key 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 |
| Date of first enrolment | 01/03/2010 |
| Date of final enrolment | 01/07/2010 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
University Dept of Anesthesiology and Pain Therapy
Bern
3010
Switzerland
3010
Switzerland
Sponsor information
Inselspital (Switzerland)
Hospital/treatment centre
Hospital/treatment centre
c/o Prof. Robert Greif - Vice-Chair
University Dept of Anesthesiology and Pain Therapy
Inselspital
Bern
3010
Switzerland
"ROR" |
https://ror.org/01q9sj412 |
|---|
Funders
Funder type
Hospital/treatment centre
Inselspital (Switzerland) - University Dept of Anesthesiology and Pain Therapy, Departmental Research Fund
No information available
Federal Office of Public Health (BAG) (Switzerland) (unrestricted grant)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Quantification and time course of subjective psychotropic and somatic effects | 18/12/2024 | 19/12/2024 | Yes | No |
| Results article | Effects on pupillary reaction and pupil size | 13/05/2025 | 06/06/2025 | Yes | No |
Editorial Notes
06/06/2025: Publication reference added.
19/12/2024: Publication reference added.
