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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00598286
First Posted: January 21, 2008
Last Update Posted: May 10, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institutes of Health Clinical Center (CC)
  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
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Imaging of Cannabinoid CB1 Receptors Using [18F]FMPEP-d2

Resource links provided by NLM:


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)
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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)