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

This study has been completed.
Sponsor:
Collaborators:
Center for Human Drug Research
Leiden University Medical Center
TI Pharma
Information provided by:
UMC Utrecht
ClinicalTrials.gov Identifier:
NCT00628706
First received: February 24, 2008
Last updated: February 17, 2009
Last verified: February 2009
  Purpose

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


Condition Intervention Phase
Reward
Tetrahydrocannabinol
Endocannabinoids
Memory
Magnetic Resonance Imaging
Drug: Delta9-tetrahydrocannabinol (THC)
Phase 1

Study Type: Interventional
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
Official Title: Investigating the Acute Effects of THC on Functional Brain Systems

Resource links provided by NLM:


Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • The main study parameter is the blood oxygen level dependent (BOLD) signal. [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Behavioral parameters (two VAS questionnaires) [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Cerebral blood flow (ASL) [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Concentration of plasma THC and its main metabolites [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Performance on neuropsychological tests [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: April 2008
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: dronabinol, marinol, THC, tetrahydrocannabinol

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).

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00628706

Locations
Netherlands
University Medical Center Utrecht
Utrecht, Netherlands, 3584CX
Sponsors and Collaborators
UMC Utrecht
Center for Human Drug Research
Leiden University Medical Center
TI Pharma
Investigators
Principal Investigator: Nick Ramsey, Professor UMC Utrecht
  More Information

No publications provided by UMC Utrecht

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. N.F. Ramsey, UMC Utrecht
ClinicalTrials.gov Identifier: NCT00628706     History of Changes
Other Study ID Numbers: THC-phMRI-01
Study First Received: February 24, 2008
Last Updated: February 17, 2009
Health Authority: Netherlands: Dutch Health Care Inspectorate
Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by UMC Utrecht:
tetrahydrocannabinol
memory
reward
magnetic resonance imaging
endocannabinoids

Additional relevant MeSH terms:
Dronabinol
Analgesics
Analgesics, Non-Narcotic
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Central Nervous System Agents
Hallucinogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014