To establish if and how the endocannabinoid system is involved in ADHD and related symptoms. This will be investigated by assessing the acute effects of a cannabinoid agonist (THC) on brain function related to ADHD and ADHD symptoms.
ID
Source
Brief title
Condition
- Psychiatric disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure of the study is the
Blood-Oxygenation-Level-Dependent (BOLD)-signal, measured with fMRI
Secondary outcome
Behavioral parameters (reaction time, accuracy) during performance of the tasks
in the scanner and during performance of the neuropsychological tests.
Melatonin levels in saliva
Bloodplasma levels of THC and its main metabolites
Background summary
The endocannabinoid system is involved in many processes in the brain. It
exists of endocannabinoid receptors and endogenous ligands (endocannabinoids)
acting on these receptors. (Abnormalities in) the endocannabinoid system are
linked to ADHD-related symptoms like sleep onset disorders and cognitive
impairments (attention deficits, impulsivity, reward system). Pharmacological
neuroimaging may contribute in our knowledge on the role of the endocannabinoid
system in ADHD.
Study objective
To establish if and how the endocannabinoid system is involved in ADHD and
related symptoms. This will be investigated by assessing the acute effects of a
cannabinoid agonist (THC) on brain function related to ADHD and ADHD symptoms.
Study design
Randomized, double-blind, placebo-controlled pharmacological fMRI study,
involving two study days on which participants either receive placebo or THC by
use of a vaporizer. On each study day subjects undergo a scanning session,
during which they perform three computer tasks. Prior to each task subjects are
administered a new (upload)dose of THC or placebo. After the scan session,
subjects perform a neuropsychological test battery.
Study burden and risks
De toediening van THC vormt de belangrijkste belasting voor de deelnemers. Het
risico is echter gering omdat:
* er een relatief lage dosering wordt gebruikt
* de deelnemers uitgebreid zijn gescreend
* de deelnemers zelf ook incidenteel cannabis gebruiken en dus bekend zijn met
de effecten.
Desondanks kan THC enige ongewenste effecten veroorzaken (angst, paranoia). De
subjectieve, gedragsmatige en fysiologische effecten (hartslag, bloeddruk)
worden daarom gedurende het hele experiment nauwlettend gemonitord.
The main burden for subjects participating in this study will be the THC
administration. The risk, however, is small because:
* a relative low dose of THC is used
* subjects are screened thoroughly
* subjects are incidental cannabis users and, therefore, are familiar with the
effects of cannabis
Nevertheless, THC could induce some adverse efffects (anxiety, paranoia).
Therefore, subjective, behavioral and physiological effects (heartrate, blood
pressure) will be monitored tightly during the whole experiment.
Heidelberglaan 100
3584CX Utrecht
NL
Heidelberglaan 100
3584CX Utrecht
NL
Listed location countries
Age
Inclusion criteria
* Diagnosed with ADHD (DSM-IV criteria)
* History of mild cannabis use for at least one year (less than once/wek and more than 4 times / year)
* Right-handedness, assessed with the Edinburgh Handedness Inventory
* Written informed consent of the participant
Exclusion criteria
* Any clinical significant abnormality of any clinical laboratory test, except for the predetermined psychiatric disorder, i.e. ADHD, including urinary screening
* Impaired physical health evaluated by medical history, physical (including neurological) examination and screening laboratory tests (see par 8.3.1.)
* history of alcohol and /or drug abuse (DSM-IV criteria)
* Body Mass Index (B.M.I) < 18 kg/m2 or > 28 kg/m2
* 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
* use of any medication within three weeks prior to the start of the study, except for paracetamol and medication for ADHD and related symptoms
* contra-indications for MRI (claustrophobia, metal objects in body (e.g. braces, pacemakers, metal clips)
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 | EUCTR2009-017944-15-NL |
| CCMO | NL30979.041.09 |