Investigating the Acute Effects of THC on Functional Brain Systems

Phase 1

Completed

• Conditions: Reward; Tetrahydrocannabinol; Endocannabinoids; Memory; Magnetic Resonance Imaging
• Interventions: Drug: Delta9-tetrahydrocannabinol (THC)

• Registration Number: NCT00628706
• Lead Sponsor: UMC Utrecht

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).

Study Timeline

• Study First Submitted: 2008-02-24
• Study First Submitted QC: 2008-02-24
• Study First Posted: 2008-03-05
• Study Start: 2008-04
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-17
• Last Update Posted: 2009-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
B	Delta9-tetrahydrocannabinol (THC)	Inhalation of vehicle, using a Volcano vaporizer
A	Delta9-tetrahydrocannabinol (THC)	Inhalation of THC, using a Volcano vaporizer

Primary Outcome Measures

Name	Time	Method
The main study parameter is the blood oxygen level dependent (BOLD) signal.	4 months

Secondary Outcome Measures

Name	Time	Method
Concentration of plasma THC and its main metabolites	4 months
Performance on neuropsychological tests	4 months
Behavioral parameters (two VAS questionnaires)	4 months
Cerebral blood flow (ASL)	4 months

Trial Locations

Locations (1)

University Medical Center Utrecht; 🇳🇱 Utrecht, Netherlands