Investigating the Acute Effects of THC on Functional Brain Systems

Magnetic Resonance Imaging Clinical Trial

— FIX  

Official title:

Investigating the Acute Effects of THC on Functional Brain Systems

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00628706
• Other study ID #: THC-phMRI-01
• Status: Completed
• Phase: Phase 1
• First received: February 24, 2008
• Last updated: February 17, 2009
• Start date: April 2008
• Est. completion date: September 2008

Study information

• Verified date: February 2009
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Dutch Health Care InspectorateNetherlands: Medical Ethics Review Committee (METC)Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Endocannabinoids
• Magnetic Resonance Imaging
• Memory
• Reward
• Tetrahydrocannabinol

Intervention

Drug:
• Delta9-tetrahydrocannabinol (THC)
inhalation of 6 mg liquid THC, vaporized by means of a Volcano vaporizer

Locations

Country	Name	City	State
Netherlands	University Medical Center Utrecht	Utrecht

Sponsors (4)

Lead Sponsor	Collaborator
UMC Utrecht	Center for Human Drug Research, Leiden University Medical Center, TI Pharma

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The main study parameter is the blood oxygen level dependent (BOLD) signal.		4 months	No
Secondary	Behavioral parameters (two VAS questionnaires)		4 months	No
Secondary	Cerebral blood flow (ASL)		4 months	No
Secondary	Concentration of plasma THC and its main metabolites		4 months	No
Secondary	Performance on neuropsychological tests		4 months	No