Clinical trial NCT00628706: Investigating the Acute Effects of THC on Functional Brain Systems
Official title: Investigating the Acute Effects of THC on Functional Brain Systems
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Reward
Tetrahydrocannabinol
Endocannabinoids
Memory
Magnetic Resonance Imaging
Keywords: tetrahydrocannabinol
memory
reward
magnetic resonance imaging
endocannabinoids
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
Collaborators: name: Center for Human Drug Research
name: Leiden University Medical Center
name: TI Pharma
First posted: 2008-03-05
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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.

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 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)

Primary outcomes:
measure: The main study parameter is the blood oxygen level dependent (BOLD) signal.
timeFrame: 4 months
Secondary outcomes:
measure: Behavioral parameters (two VAS questionnaires)
timeFrame: 4 months
measure: Cerebral blood flow (ASL)
timeFrame: 4 months
measure: Concentration of plasma THC and its main metabolites
timeFrame: 4 months
measure: Performance on neuropsychological tests
timeFrame: 4 months
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
Study officials:
affiliation: UMC Utrecht
name: Nick Ramsey, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bossong MG, Jager G, van Hell HH, Zuurman L, Jansma JM, Mehta MA, van Gerven JM, Kahn RS, Ramsey NF. Effects of Delta9-tetrahydrocannabinol administration on human encoding and recall memory function: a pharmacological FMRI study. J Cogn Neurosci. 2012 Mar;24(3):588-99. doi: 10.1162/jocn_a_00156. Epub 2011 Nov 8.