Condition category
Nervous System Diseases
Date applied
21/07/2006
Date assigned
21/07/2006
Last edited
21/07/2006
Prospective/Retrospective
Prospectively 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 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

Publication citations

Additional files

Editorial Notes