Investigating the Acute Effects of THC on Functional Brain Systems
Information source: UMC Utrecht
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Reward; Tetrahydrocannabinol; Endocannabinoids; Memory; Magnetic Resonance Imaging
Intervention: Delta9-tetrahydrocannabinol (THC) (Drug)
Phase: Phase 1
Status: Not yet recruiting
Sponsored by: UMC Utrecht Official(s) and/or principal investigator(s):
Nick Ramsey, Professor, Principal Investigator, Affiliation: University Medical Center Utrecht
Overall contact:
Matthijs Bossong, MSc, Phone: +31-887557950, Email: m.bossong@umcutrecht.nl
Summary
The purpose of this study is to determine whether THC, the main psychoactive ingredient in
cannabis, affects functional brain systems underlying memory and reward.
Clinical Details
Official title: Investigating the Acute Effects of THC on Functional Brain Systems
Study design: Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Pharmacokinetics/Dynamics Study
Primary outcome: The main study parameter is the blood oxygen level dependent (BOLD) signal.
Secondary outcome: Behavioral parameters (two VAS questionnaires)Cerebral blood flow (ASL) Concentration of plasma THC and its main metabolites Performance on neuropsychological tests
Detailed description:
Cannabis is by far the most frequently used illicit drug worldwide and has significant
effects on memory. Further, cannabis has an addictive potential. These effects are mediated
by an action of THC, the main psychoactive ingredient of cannabis, on cannabinoid CB1
receptors. These receptors are particularly highly expressed in brain regions involved in
memory and reward. Therefore, in this study we will investigate the acute effects of THC on
functional brain systems underlying memory and reward. We will visualize these effects using
the latest non-invasive imaging technique: pharmacological MRI (phMRI).
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- History of mild cannabis use for at least one year (<1/week and ≥ 4/year)
- History without psychotic experiences after cannabis use
- Age between 18 and 45 years
- Right-handedness, assessed with the Edinburgh Handedness Inventory
- Written informed consent of the subject
Exclusion Criteria:
- Any clinical significant abnormality of any clinical laboratory test, including
urinary drug screening
- Impaired physical health evaluated by medical history, physical (including
neurological) examination and screening laboratory tests
- History of clinically significant psychiatric or neurological illness
- History of clinically significant psychiatric or neurological illness in first- or
second-degree relatives
- History of alcohol and/or drug abuse (DSM-IV criteria)
- Body Mass Index (B. M.I.) <18 kg/m2 or >28 kg/m2
- Paranoid ideation or psychoticism on SCL-90
- 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
- The use of any medication within three weeks prior to the start of the study, except
for paracetamol
- Positive HIV or Hepatitis B/C test
- Blood donation within 3 months before the start of the study
- Claustrophobia
- Metal objects in or around the body (braces, pacemaker, metal fragments)
Locations and Contacts
Matthijs Bossong, MSc, Phone: +31-887557950, Email: m.bossong@umcutrecht.nl
University Medical Center Utrecht, Utrecht 3584CX, Netherlands
Additional Information
Starting date: April 2008
Ending date: July 2008
Last updated: February 24, 2008
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