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Investigating the Acute Effects of THC on Functional Brain Systems

Investigating the Acute Effects of THC on Functional Brain Systems

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00628706
Acronym
FIX
Enrollment
12
Registered
2008-03-05
Start date
2008-04-30
Completion date
2008-09-30
Last updated
2009-02-18

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

Conditions

Endocannabinoids, Magnetic Resonance Imaging, Memory, Reward, Tetrahydrocannabinol

Keywords

tetrahydrocannabinol, memory, reward, magnetic resonance imaging, endocannabinoids

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).

Interventions

DRUGDelta9-tetrahydrocannabinol (THC)

inhalation of 6 mg liquid THC, vaporized by means of a Volcano vaporizer

Sponsors

Center for Human Drug Research
CollaboratorUNKNOWN
Leiden University Medical Center
CollaboratorOTHER
TI Pharma
CollaboratorUNKNOWN
UMC Utrecht
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frame
The main study parameter is the blood oxygen level dependent (BOLD) signal.4 months

Secondary

MeasureTime frame
Behavioral parameters (two VAS questionnaires)4 months
Cerebral blood flow (ASL)4 months
Concentration of plasma THC and its main metabolites4 months
Performance on neuropsychological tests4 months

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026