Condition category
Not Applicable
Date applied
22/02/2010
Date assigned
14/04/2010
Last edited
14/04/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Lorenz Theiler

ORCID ID

Contact details

University Dept of Anesthesiology and Pain Therapy
Inselspital
Bern
3010
Switzerland
ltheiler@med.miami.edu

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

THLD2010-1

Study information

Scientific title

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

Acronym

Study hypothesis

Rate of intravenous applied d-9THC depends on genetically determined CYP2C9, where two polymorphisms (SNP) are known

Ethics approval

Cantonal Ethics Committee of Bern approved on the 22nd of February 2010 (ref: KEK-Number 241/09)

Study design

Single centre open label uncontrolled interventional pharmacokinetic study

Primary study design

Interventional

Secondary study design

Cohort study

Trial setting

Other

Trial type

Other

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

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

Phase

Not Specified

Drug names

d-9-Tetrahydrocannabinol (THC)

Primary outcome measures

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 trial start date

01/03/2010

Overall trial end date

01/07/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Healthy volunteers
2. 18-65 years old

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

Screening: 300, Inclusion in Study: 30

Participant 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

Recruitment start date

01/03/2010

Recruitment end date

01/07/2010

Locations

Countries of recruitment

Switzerland

Trial participating centre

University Dept of Anesthesiology and Pain Therapy
Bern
3010
Switzerland

Sponsor information

Organisation

Inselspital (Switzerland)

Sponsor details

c/o Prof. Robert Greif - Vice-Chair
University Dept of Anesthesiology and Pain Therapy
Inselspital
Bern
3010
Switzerland

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Inselspital (Switzerland) - University Dept of Anesthesiology and Pain Therapy, Departmental Research Fund

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Federal Office of Public Health (BAG) (Switzerland) (unrestricted grant)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes