Investigating the Acute Effects of THC on Functional Brain Systems (FIX)

February 17, 2009 updated by: UMC Utrecht
The purpose of this study is to determine whether THC, the main psychoactive ingredient in cannabis, affects functional brain systems underlying memory and reward.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Utrecht, Netherlands, 3584CX
        • University Medical Center Utrecht

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Inhalation of THC, using a Volcano vaporizer
Drug: Delta9-tetrahydrocannabinol (THC)
inhalation of 6 mg liquid THC, vaporized by means of a Volcano vaporizer
Other Names:
  • dronabinol, marinol, THC, tetrahydrocannabinol
Placebo Comparator: B
Inhalation of vehicle, using a Volcano vaporizer
Drug: Delta9-tetrahydrocannabinol (THC)
inhalation of 6 mg liquid THC, vaporized by means of a Volcano vaporizer
Other Names:
  • dronabinol, marinol, THC, tetrahydrocannabinol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The main study parameter is the blood oxygen level dependent (BOLD) signal.
Time Frame: 4 months
4 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UMC Utrecht

Collaborators

Leiden University Medical Center
Center for Human Drug Research
TI Pharma

Investigators

  • Principal Investigator: Nick Ramsey, Professor, UMC Utrecht

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

February 24, 2008

First Submitted That Met QC Criteria

February 24, 2008

First Posted (Estimate)

March 5, 2008

Study Record Updates

Last Update Posted (Estimate)

February 18, 2009

Last Update Submitted That Met QC Criteria

February 17, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • THC-phMRI-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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