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
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