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van CCT (UK)

van CCT (UK)

Investigating the acute effects of THC on functional brain systems

- candidate number3043
- NTR NumberNTR1204
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR3-mrt-2008
- Secondary IDs06-269 METC Utrecht
- Public TitleInvestigating the acute effects of THC on functional brain systems
- Scientific TitleInvestigating the acute effects of THC on functional brain systems: an fMRI study.
- ACRONYMTHC-fMRI in healthy volunteers
- hypothesisInhalation of delta9-THC will modulate activity in functional brain systems, including the reward system, the working memory system and the associative memory system.
- Healt Condition(s) or Problem(s) studiedCannabis, Functional MRI (fMRI), Tetrahydrocannabinol (THC), Functional brain systems
- Inclusion criteria1. History of mild cannabis use for at least one year (<1/week and ”Ż 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 criteria1. 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.) <18 kg/m2 or >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)
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-apr-2008
- planned closingdate1-aug-2008
- Target number of participants12
- InterventionsHealthy 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.
- 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.
- Trial web siteN/A
- statusplanned
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
Top Institute Pharma (TI Pharma)
- PublicationsN/A
- Brief summaryCannabis is by far the most frequently used illicit drug worldwide. THC, the main psychoactive component in cannabis, exerts its effects via CB1 cannabinoid receptors. CB1 receptors are abundantly expressed in the striatum, the hippocampus, and the frontal cortex. These brain regions are involved in reward, associative memory, and working memory, respectively. Therefore, the main objective of this study is to determine whether THC modulates activity in these functional brain systems. The study is a randomized, double-blind, placebo-controlled pharmacological MRI experiment. It consists of 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.
- Main changes (audit trail)
- RECORD31-jan-2008 - 3-apr-2008

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