The main objective of this study is to determine whether THC, the primary psychoactive ingredient in cannabis, modulates activity in functional brain systems. We test this by assessing the acute effects of THC on the reward system, the working…
ID
Source
Brief title
Condition
- Psychiatric disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the blood-oxygen-level dependent (BOLD) signal.
Secondary outcome
Further, behavioral parameters and the concentration of plasma THC and its main
metabolites will be obtained.
Background summary
Cannabis is by far the most frequently used illicit drug worldwide. The use of
cannabis is associated with a variety of neuropsychiatric diseases, like
addiction and schizophrenia. Elucidating the effects of cannabis on the brain
is therefore of significant importance.
Study objective
The main objective of this study is to determine whether THC, the primary
psychoactive ingredient in cannabis, modulates activity in functional brain
systems. We test this by assessing the acute effects of THC on the reward
system, the working memory system and the associative memory system.
Study design
The study consists of a randomized, double-blind, placebo-controlled
pharmacological MRI experiment. The study takes up two test days, on which
subjects receive either placebo or THC by means of a vaporizer. On a test day
subjects undergo three sessions of obtaining MRI scans. During each session,
subjects will perform one of the following tasks: a reward task, a working
memory task and an associative memory task. A fourth session includes the
performance of neuropsychological tests. At the beginning of every session
subjects receive a new dose of THC or placebo.
Study burden and risks
In this study the burden is especially formed by the administration of THC.
However, the risk is small, mainly because of the fact that the subjects have
been screened extensively and that they have experience with the effects of
cannabis. Nevertheless, THC could induce some adverse effects. Therefore heart
rate and behavioral effects will be monitored during the whole experiment.
Heidelberglaan 100
3584 CX Utrecht
Nederland
Heidelberglaan 100
3584 CX Utrecht
Nederland
Listed location countries
Age
Inclusion criteria
* History of mild cannabis use for at least one year (<1/week and <=>4/year)
* History without psychotic experiences after cannabis use
* Age between 18 and 45 years
* Right-handedness, assessed with the Edinburgh Handedness Inventory
* Written informed consent of the subject
Exclusion criteria
* Any clinical significant abnormality of any clinical laboratory test, including drug screening
* Impaired physical health evaluated by medical history, physical (including neurological) examination and screening laboratory tests
* History of clinically significant psychiatric or neurological illness
* History of clinically significant psychiatric or neurological illness in first- or second-degree relatives
* History of alcohol and/or drug abuse (DSM-IV criteria)
* Body Mass Index (B.M.I.) <18 kg/m2 or >28 kg/m2
* Paranoid ideation or psychoticism on SCL-90
* Any subject who received any investigational medication within 90 days prior to the start of the study or who is scheduled to receive an investigational drug
* The use of any medication within three weeks prior to the start of the study, except for paracetamol
* Positive HIV or Hepatitis B/C test
* Blood donation within 3 months before the start of the study
* Claustrophobia
* Metal objects in or around the body (braces, pacemaker, metal fragments)
Design
Recruitment
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 | EUCTR2006-004482-33-NL |
| CCMO | NL14098.041.07 |