PET Imaging of Cannabinoid CB1 Receptors Using [11C]MePPEP | NCT00598390

Studies
PET Imaging of Cannabinoid CB1 Receptors Using [11C]MePPEP

NCT00598390

Sponsor

National Institute of Mental Health (NIMH)

Status

Completed

Last Update Posted

Apr 2, 2020Actual

Enrollment

19Actual

Phase

Phase 1

Conditions

Healthy

Interventions

[11C]MePPEP

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
08-M-0048

Status Module

Record Verification Date

Jan 22, 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 8, 2008

Primary Completion Date

Jan 22, 2013Actual

Completion Date

Jan 22, 2013Actual

First Submitted Date

Jan 10, 2008

First Submission Date that Met QC Criteria

Jan 10, 2008

First Posted Date

Jan 21, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 1, 2020

Last Update Posted Date

Apr 2, 2020Actual

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

19Actual

Name	Type	Description	Arm Group Labels	Other Names
[11C]MePPEP	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reproducibility of novel PET tracer for CB1 in brain imaging.

Secondary Outcomes

Measure	Description	Time Frame
Distribution and variance of CB1 receptors in the brain of healthy controls.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

INCLUSION CRITERIA:

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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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Robert B Innis, M.D.	National Institute of Mental Health (NIMH)	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Institutes of Health Clinical Center, 9000 Rockville Pike		Bethesda	Maryland	20892	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
7830108	Background	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.
9374364	Background	Burger C, Buck A. Requirements and implementation of a flexible kinetic modeling tool. J Nucl Med. 1997 Nov;38(11):1818-23.