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OpenTrials
Completed

NCT Number: NCT00628706

Investigating the Acute Effects of THC on Functional Brain Systems

The purpose of this study is to determine whether THC, the main psychoactive ingredient in cannabis, affects functional brain systems underlying memory and reward.

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Key information

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

University Medical Center Utrecht

Utrecht, 3584CX, Netherlands

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Delta9-tetrahydrocannabinol (THC)

Drug

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

Other names: dronabinol, marinol, THC, tetrahydrocannabinol

Primary outcomes

  1. The main study parameter is the blood oxygen level dependent (BOLD) signal.

    Time frame: 4 months

Secondary outcomes

  1. Behavioral parameters (two VAS questionnaires)

    Time frame: 4 months

  2. Cerebral blood flow (ASL)

    Time frame: 4 months

  3. Concentration of plasma THC and its main metabolites

    Time frame: 4 months

  4. Performance on neuropsychological tests

    Time frame: 4 months

Sponsors and collaborators

Lead sponsor

UMC Utrecht

Other

Collaborators

  • Center for Human Drug Research
  • Leiden University Medical Center
  • TI Pharma

Registry information

Acronym: FIX

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Mar 5, 2008
Registry last updated
Feb 18, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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