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PET Imaging of Cannabinoid CB1 Receptors Using [18F]FMPEP-d2

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00598286
First received: January 10, 2008
Last updated: May 9, 2012
Last verified: May 2012
History of Changes
  Purpose

The purpose of this protocol is to measure brain CB1 receptors in the hope to better understand how they work, so that one day we can understand how the CB1 receptors are involved in psychiatric, neurological, and behavioral disorders.


Condition Intervention Phase
CB1
Cannabinoid
PET
[18F]FMPEP-d2
Brain Imaging
 Drug: [18F]FMPEP-d2
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Imaging of Cannabinoid CB1 Receptors Using [18F]FMPEP-d2

Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Efficacy of novel PET tracer for CB1 in brain imaging.

Secondary Outcome Measures:
  • Distribution and variance of CB1 receptors in the brain of healthy controls.

Enrollment: 18
Study Start Date: January 2008
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: [18F]FMPEP-d2
    N/A
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:
  • All subjects must be healthy and aged 18-65 years, with history/physical exam, ECG, and laboratory tests within one year of the PET scan.
  • The volunteer must sign an informed consent form.

EXCLUSION CRITERIA:

  • Current psychiatric illness, substance abuse including marijuana use, or severe systemic disease based on history and physical exam.
  • Laboratory tests with clinically significant abnormalities or positive urine toxicology screen.
  • Prior participation in other research protocols in the last year such that radiation exposure would exceed the annual limits.
  • Pregnancy and breast feeding.
  • Claustrophobia.
  • Presence of ferromagnetic metal in the body or heart pacemaker.
  • Positive HIV test.
  • Employee of the investigative site or an immediate family member of an employee of the investigative site. Immediate family member is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
  • Employee of Eli Lilly and Company.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00598286

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institute of Mental Health (NIMH)
  More Information

Additional Information:
NIH Clinical Center Detailed Web Page  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Robert B. Innis, M.D./National Institute of Mental Health, National Institutes of Health
ClinicalTrials.gov Identifier: NCT00598286     History of Changes
Other Study ID Numbers: 080049, 08-M-0049
Study First Received: January 10, 2008
Last Updated: May 9, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
CB1 Receptor
PET
Cannabinoid
[18F]FMPEP-d2
 Brain Imaging
Healthy Volunteer
HV

ClinicalTrials.gov processed this record on May 21, 2013