PET Imaging of Cannabinoid CB1 Receptors Using [11C]MePPEP - Full Text View

Sponsor:	National Institute of Mental Health (NIMH)
Information provided by:	National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:	NCT00598390

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
Healthy	Drug: [11C]MePPEP	Phase I Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	PET Test/Retest Brain Imaging of Cannabinoid CB1 Receptors Using [11C]MePPEP

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

Primary Outcome Measures:

Reproducibility of novel PET tracer for CB1 in brain imaging.

Secondary Outcome Measures:

Distribution and variance of CB1 receptors in the brain of healthy controls.

Estimated Enrollment:	30
Study Start Date:	January 2008
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Intervention Details:

N/A

Detailed Description:

MePPEP is a ligand that is highly selective for the cannabinoid type 1 (CB1) receptor. This receptor is considered the most common G-coupled protein receptor in the brain (Pacher et al., 2006). The CB1 receptor is the site of action of Delta-9-tetrahydrocannbinol (THC), the active compound in marijuana, and is found primarily on the presynaptic terminals of dopaminergic, glutamatergic, GABAergic neurons (Howlett et al., 2002). The function of the CB1 receptor is not entirely clear; however, it has been implicated in several neurological and psychiatric disorders, and a selective inverse agonist, rimonabant, is currently in use in Europe for the treatment of obesity (Van Gaal et al., 2005). [11C]MePPEP was developed to enhance our understanding of the in vivo characteristics of the CB1 receptor (e.g., receptor density and receptor occupancy with pharmaceuticals).

The purpose of this protocol is to establish an accurate method to measure CB1 receptor levels in brain by performing test/retest brain imaging studies. The results of this overall study are required to apply this PET ligand in various neurological and psychiatric disorders in the future.

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: NCT00598390

Contacts

Contact: Patient Recruitment and Public Liaison Office	(800) 411-1222	prpl@mail.cc.nih.gov
Contact: TTY	1-866-411-1010

Locations

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike	Recruiting
Bethesda, Maryland, United States, 20892
Sub-Investigator: Patient Recruitment and Public Liaison Office (PRPL) For more information at the NIH Clinical Center contact

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.

Carson RE, Huang SC, Green MV. Weighted integration method for local cerebral blood flow measurements with positron emission tomography. J Cereb Blood Flow Metab. 1986 Apr;6(2):245-58.

Responsible Party:	Robert B. Innis, M.D./National Institute of Mental Health, National Institutes of Health
ClinicalTrials.gov Identifier:	NCT00598390 History of Changes
Other Study ID Numbers:	080048, 08-M-0048
Study First Received:	January 10, 2008
Last Updated:	January 19, 2012
Health Authority:	United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):

Cannabinoid
CB1 Receptor
Brain Imaging
PET Imaging

[11C]MePPEP
Healthy Volunteer
HV

ClinicalTrials.gov processed this record on February 09, 2012