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Investigating the acute effects of THC on functional brain systems

Investigating the acute effects of THC on functional brain systems: an fMRI study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON22844
Enrollment
12
Registered
2008-03-03
Start date
2008-04-01
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

no condition, healthy person.

Interventions

Healthy subjects will inhale placebo or 6 mg THC, the main psychoactive ingredient of cannabis, four times by means of a Volcano® vaporizer. Inhalation takes 1 - 2 minutes.

Sponsors

University Medical Centre Utrecht
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. History of mild cannabis use for at least one year (<1/week and ¡Ý 4/year) 2. History without psychotic experiences after cannabis use 3. Age between 18 and 45 years 4. Right-handedness, assessed with the Edinburgh Handedness Inventory (Oldfield, 1971 5. Written informed consent of the subject

Exclusion criteria

Exclusion criteria: 1. Any clinical significant abnormality of any clinical laboratory test, including urinary drug screening 2. Impaired physical health evaluated by medical history, physical (including neurological) examination and screening laboratory tests 3. History of clinically significant psychiatric or neurological illness 4. History of clinically significant psychiatric or neurological illness in first- or second-degree relatives 5. History of alcohol and/or drug abuse (DSM-IV criteria) 6. Body Mass Index (B.M.I.) 28 kg/m2 7. Paranoid ideation or psychoticism on SCL-90 8. 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 9. The use of any medication within three weeks prior to the start of the study, except for paracetamol 10. Positive HIV or Hepatitis B/C test 11. Blood donation within 3 months before the start of the study 12. Claustrophobia 13. 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 ContactM.G. Bossong

University Medical Center Utrecht (UMCU), Department of Psychiatry, Heidelberglaan 100, P.O. Box 85500

M.Bossong@umcutrecht.nl+31 (0)30 2507121

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)