Investigating the Acute Effects of THC on Functional Brain Systems - Full Text View

Sponsor:	UMC Utrecht
Collaborators:	Center for Human Drug Research Leiden University Medical Center TI Pharma
Information provided by:	UMC Utrecht
ClinicalTrials.gov Identifier:	NCT00628706

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 I

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:

MedlinePlus related topics: MRI Scans Memory

Drug Information available for: Tetrahydrocannabinol

U.S. FDA Resources

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

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

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:

Tetrahydrocannabinol
Hallucinogens
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on February 12, 2012