Contact information
Type
Scientific
Primary contact
Dr M.G. Bossong
ORCID ID
Contact details
University Medical Center Utrecht (UMCU)
Department of Psychiatry
Heidelberglaan 100
P.O. Box 85500
Utrecht
3584 CX
Netherlands
+31 (0)30 2507121
M.Bossong@umcutrecht.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
THC-PET study
Study hypothesis
Inhalation of delta9-tetrahydrocannabinol (THC) will stimulate dopamine release in striatum and its sub-regions
Ethics approval
Not provided at time of registration
Study design
Randomised, double-blind, placebo-controlled, crossover trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
No condition, healthy person
Intervention
Healthy subjects will inhale placebo or 8 mg of THC, the main psychoactive ingredient of cannabis, by means of a vaporizer.
Intervention type
Drug
Phase
Not Specified
Drug names
Tetrahydrocannabinol
Primary outcome measures
After inhalation of THC, dopamine release will be investigated using the 11C-raclopride displacement paradigm. Increase in striatal synaptic dopamine will be measured by the decline in D2 receptor availability to the binding of 11C-raclopride. This binding will be demonstrated using positron emission tomography (PET).
Secondary outcome measures
Behavioral parameters (brief psychiatric rating scale [BPRS] and two visual analogue scale [VAS] questionnaires) and the concentration of plasma THC and its main metabolites will be obtained as well. Vital signs (blood pressure and heart rate) will be measured regularly.
Overall trial start date
01/08/2006
Overall trial end date
31/12/2006
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged between 18 and 45 years
2. History of mild cannabis use for at least one year (<1 per week and >=4 per year
3. History of no further illicit drug use
4. History of no psychotic experiences after cannabis use
5. Written informed consent of the subject
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
7
Participant exclusion criteria
1. Any clinically significant abnormality of any clinical laboratory test, including drug screening
2. Impaired physical health evaluated by medical history, physical (including neurological) examination and screening laboratory tests
3. Any major current psychiatric diagnosis on axis-1 of Diagnostic and Statistical Manual of Mental Disorders (DSM-IV)
4. History of clinically significant psychiatric or neurological illness
5. History of clinically significant psychiatric or neurological illness in first- or second-degree relatives
6. History of alcohol and/or drug abuse (DSM-IV criteria)
7. Paranoid ideation or psychoticism on Symptom checklist-90 (SCL-90)
8. Any subject who has received any investigational medication within 90 days prior to the start of the study or who is scheduled to receive any investigational drugs
9. The use of any medication within three weeks prior to the start of the study, except for paracetamol
10. Positive human immunodeficiency virus (HIV) or hepatitis B or hepatitis C test
11. Blood donation within three months before the first day of test
12. Haemoglobin (Hb) must be =>8 mmol per liter (males) or =>7 mmol per liter (females)
13. Body mass index (BMI) between 18 and 28 kg/m^2
14. Claustrophobia
15. Metal objects in or around the body (braces, pacemaker, metal fragments)
16. Pregnancy and breast feeding
17. Exposure to radioactivity leading to a yearly cumulative dose of 10 mSv or more
Recruitment start date
01/08/2006
Recruitment end date
31/12/2006
Locations
Countries of recruitment
Netherlands
Trial participating centre
University Medical Center Utrecht (UMCU)
Utrecht
3584 CX
Netherlands
Sponsor information
Organisation
University Medical Center Utrecht (UMCU), Department of Psychiatry (The Netherlands)
Sponsor details
Heidelberglaan 100
Utrecht
3584 CX
Netherlands
+31 (0)30 2509019
h.g.m.westenberg@azu.nl
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
VU University Medical Center
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
University Medical Center Utrecht (UMCU)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Centre for Human Drug Research (CHDR), Leiden
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