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

Pharmacological Imaging of the Cannabinoid system: a pharmacological MRI study.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON20111
Enrollment
120
Registered
2009-04-29
Start date
2009-02-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

psychiatric disorders (schizophrenia, addiction, OCD, ADHD, depression), fMRI, THC, cannabinoid system

Interventions

1. 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.

Sponsors

Prof. Dr. N.F. Ramsey
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. 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 ¡Ý 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 criteria

Exclusion criteria: 1. 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.) 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).

Design outcomes

Primary

MeasureTime frame
The main study parameter is the blood oxygen level dependent (BOLD) signal.

Secondary

MeasureTime frame
Behavioral 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.

Contacts

Public ContactH.H. Hell, van
h.h.vanhell@umcutrecht.nl+31 (0)88 7555873

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)