The following research questions are formulated:A. Does exposure to cannabis (THC) result in an increased dopamine response in the striatum (as measured with PET)? And does cannabis use lead to an increase in psychotic experiences or symptoms?B. Do…
ID
Source
Brief title
Condition
- Schizophrenia and other psychotic disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
(i) Dopamine response after THC and placebo
(ii) Psychotic experiences in response to THC and placebo as measured with i)
computer-assisted tasks and ii) clinical interviewing
Secondary outcome
(i) genotype (on the basis of DNA analyses)
Background summary
Cannabis use is considered to be an environmental factor that contributes to
the risk of developing psychosis. Individuals with a certain genetic
vulnerability seem to be particularly sensitive to the psychotic effects of
cannabis. However, the biological mechanism that underlies this relation
remains unknown.
Study objective
The following research questions are formulated:
A. Does exposure to cannabis (THC) result in an increased dopamine response in
the striatum (as measured with PET)? And does cannabis use lead to an increase
in psychotic experiences or symptoms?
B. Do genetic factors exert an influence on the effects of THC on dopamine and
psychotic experiences?
Study design
The study makes use of a placebo-controlled single-blind design.
Intervention
Participants will be asked to inhale THC and placebo in one session and to
subsequently undergo a PET scans. In addition they will be asked to undergo a
total of 1 MRI scan.
Study burden and risks
Healthy participants may temporarily experience psychotomimetic effects.
Patients may temporarily experience worsening of psychotic symptoms. For both
groups these effects will only be transient, lasting maximal 200 minutes.
The study will approximately take 8 hours within a range of two weeks.
Vijverdalseweg 1
6226 NB
Nederland
Vijverdalseweg 1
6226 NB
Nederland
Listed location countries
Age
Inclusion criteria
18-50 years of age
life-time use of cannabis without having experienced negative effects
BMI between 18.5 and 27
diagnosis of schizophrenia according to DSM-IV (only patients)
having given informed consent (written and orally)
Exclusion criteria
head trauma
severe renal or liver dysfunction
alcohol use in excess of 5 units per day
weekly use of illicit drugs (other than cannabis)
pregnancy
breast-feeding
personal or family history of psychosis or use of antipsychotic medication (only valid for healthy participants who are no first degree relatives of patients with schizophrenia)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2008-001964-35-NL |
| CCMO | NL22847.068.08 |