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

Sponsor:	National Institute of Mental Health (NIMH)
Information provided by:	National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:	NCT00598286

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:

N/A

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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:

Abi-Dargham A, Gandelman M, Zoghbi SS, Laruelle M, Baldwin RM, Randall P, Zea-Ponce Y, Charney DS, Hoffer PB, Innis RB. Reproducibility of SPECT measurement of benzodiazepine receptors in human brain with iodine-123-iomazenil. J Nucl Med. 1995 Feb;36(2):167-75.

Burger C, Buck A. Requirements and implementation of a flexible kinetic modeling tool. J Nucl Med. 1997 Nov;38(11):1818-23.

Burns HD, Van Laere K, Sanabria-Bohórquez S, Hamill TG, Bormans G, Eng WS, Gibson R, Ryan C, Connolly B, Patel S, Krause S, Vanko A, Van Hecken A, Dupont P, De Lepeleire I, Rothenberg P, Stoch SA, Cote J, Hagmann WK, Jewell JP, Lin LS, Liu P, Goulet MT, Gottesdiener K, Wagner JA, de Hoon J, Mortelmans L, Fong TM, Hargreaves RJ. [18F]MK-9470, a positron emission tomography (PET) tracer for in vivo human PET brain imaging of the cannabinoid-1 receptor. Proc Natl Acad Sci U S A. 2007 Jun 5;104(23):9800-5. Epub 2007 May 29.

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 24, 2012