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The Role of the Endocannabinoid System in Psychiatric Disorders and Symptoms: a Pharmacological fMRI study.


- candidate number5675
- NTR NumberNTR1787
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-apr-2009
- Secondary IDs07/371  METC Utrecht
- Public TitleThe Role of the Endocannabinoid System in Psychiatric Disorders and Symptoms: a Pharmacological fMRI study.
- Scientific TitlePharmacological Imaging of the Cannabinoid system: a pharmacological MRI study.
- ACRONYMTHC-phMRI in patients
- hypothesisThe endocannabinoid system is involved in cognitive functioning, and therefore, challenging this system with THC will influence cognitive processing in humans. Moreover, subjects with cognitive impairments (i.e. psychiatric patients) will react differently on a cannabinoid challenge than healthy controls.
- Healt Condition(s) or Problem(s) studiedMental illness, Schizophrenia, Depression, Obsessive-compulsive disorder (OCD), ADHD, Addiction
- Inclusion criteria1. Healthy control or Diagnosed with one psychiatric disorder, according to DSM-IV criteria, axis I:
A. Schizophrenia;
B. Depression;
C. ADHD;
D. Addiction to nicotine (heavy smokers);
E. OCD.
2. Male;
3. Current occasional cannabis use since at least one year (<1/week and 4/year) without known negative implications (e.g. bad trip, cannabis-induced psychosis);
4. Right-handedness, assessed with the Edinburgh Handedness Inventory (Oldfield, 1971);
5. Written informed consent of the subject.
- Exclusion criteria1. Clinical significant abnormalities, except for the predetermined psychiatric disorder;
2. For healthy controls, first degree relatives with a psychiatric disorder according to DSM IV;
3. Impaired physical health evaluated by medical history and physical (including neurological) examination;
4. Current diagnosis of abuse of drugs or alcohol (according to DSM-IV) except for tobacco;
5. Past but recent diagnosis of abuse of drugs or alcohol other than tobacco, i.e. within 12 months preceding study inclusion;
6. Body Mass Index (B.M.I.) <18 kg/m2 or >28 kg/m2;
7. 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;
8. The use of any medication within three weeks prior to the start of the study, except for paracetamol and medication for the psychiatric disorder;
9. Blood donation within 3 months before the start of the study;
10. Claustrophobia;
11. Metal objects in or around the body (braces, pacemaker, metal fragments).
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2009
- planned closingdate1-apr-2011
- Target number of participants120
- Interventions1. THC will be inhaled (5 times: first dose 6 mg, upload doses 1 mg) by means of a Vulcano Vaporizer;
2. Functional MRI scans will be performed during cognitive tasks.
- Primary outcomeThe main study parameter is the blood oxygen level dependent (BOLD) signal.
- Secondary outcomeBehavioral parameters (two sets of visual analogue scales), cerebral blood flow (measured with Arterial Spin Labeling), the concentration of plasma THC and its main metabolites, and the performance on neuropsychological tests will be measured.
- TimepointsFunctional MRI scans will be obtained between 7 and 21 minutes after inhalation. Behavioral parameters will be measured and blood samples will be withdrawn before and after functional MRI. Two testdays are performed (one day placebo, one day THC), two weeks apart.
- Trial web sitewww.cannabisonderzoek.nl
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. H.H. Hell, van
- CONTACT for SCIENTIFIC QUERIESDrs. H.H. Hell, van
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
Top Institute Pharma (TI Pharma)
- PublicationsN/A
- Brief summaryExtensive research has identified and characterized an endocannabinoid system in the human central nervous system. It consists of cannabinoid receptors and endocannabinoids that work on the receptors. Recently, the endocannabinoid system has been associated with several psychiatric disorders, such as schizophrenia, depression and addiction. This system provides a novel potential target for medical treatment of these disorders. This study assesses the role of the endocannabinoid system in symptoms of psychiatric disorders. THC, which is the main psychoactive constituent of cannabis, works on cannabinoid receptors as an agonist. The study is a randomized, double-blind, placebo-controlled pharmacological MRI experiment in which healthy controls will be compared to patients with a psychiatric disorder. The study consists of two test days, on which subjects receive either placebo or THC by means of a vaporizer. On a test day subjects will perform three cognitive tasks, during which functional MRI scans will be measured. Also, a series of neuropsychological tests will be performed. Before every task subjects receive a new dose of THC or placebo.
- Main changes (audit trail)
- RECORD29-apr-2009 - 23-sep-2009


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