The effects of tetrahydrocannabinol on dopamine release

ISRCTN	ISRCTN61445818
DOI	https://doi.org/10.1186/ISRCTN61445818
Secondary identifying numbers	NL645, NTR706

Submission date: 21/07/2006
Registration date: 21/07/2006
Last edited: 08/01/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr M.G. Bossong
Scientific

University Medical Center Utrecht (UMCU)
Department of Psychiatry
Heidelberglaan 100
P.O. Box 85500
Utrecht
3584 CX
Netherlands

Phone	+31 (0)30 2507121
Email	M.Bossong@umcutrecht.nl

Study information

Study design	Randomised, double-blind, placebo-controlled, crossover trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title	The effects of tetrahydrocannabinol on dopamine release
Study acronym	THC-PET study
Study objectives	Inhalation of delta9-tetrahydrocannabinol (THC) will stimulate dopamine release in striatum and its sub-regions
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Tetrahydrocannabinol
Primary outcome measure	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 study start date	01/08/2006
Completion date	31/12/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	45 Years
Sex	Both
Target number of participants	7
Total final enrolment	7
Key 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
Key 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
Date of first enrolment	01/08/2006
Date of final enrolment	31/12/2006

Locations

Countries of recruitment

Netherlands

Study participating centre

University Medical Center Utrecht (UMCU)

Utrecht
3584 CX
Netherlands

Sponsor information

University Medical Center Utrecht (UMCU), Department of Psychiatry (The Netherlands)
University/education

Heidelberglaan 100
Utrecht
3584 CX
Netherlands

Phone	+31 (0)30 2509019
Email	h.g.m.westenberg@azu.nl
"ROR"	https://ror.org/0575yy874

Funders

Funder type

University/education

VU University Medical Center

No information available

University Medical Center Utrecht (UMCU)

No information available

Centre for Human Drug Research (CHDR), Leiden

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	results	01/02/2009	08/01/2021	Yes	No

Editorial Notes

08/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
3. The NTR numbers have been added.