Viewing Study NCT00062946



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Last Modification Date: 2024-10-26 @ 9:08 AM
Study NCT ID: NCT00062946
Status: COMPLETED
Last Update Posted: 2017-07-02
First Post: 2003-06-17

Brief Title: PET Imaging of Dopamine in Healthy Study Participants
Sponsor: National Institute of Mental Health NIMH
Organization: National Institutes of Health Clinical Center CC

Study Overview

Official Title: PET Imaging of Dopamine D2 Receptors and Extracellular Dopamine With 18FFallypride D-amphetamine and Alpha-Methyl-Para-Tyrosine in Healthy Subjects
Status: COMPLETED
Status Verified Date: 2007-08-15
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The purpose of this study is to measure molecules on or in cells that interact with a chemical in the nervous system called dopamine Investigators will obtain two kinds of images of the brain-a position emission tomography PET scan and a magnetic resonance imaging MRI scan

Thirty-eight participants aged 18 to 45 will be enrolled in this study They must have no history of medical or psychiatric illness including substance abuse Participants will have four appointments at NIH On the first visit they will undergo a physical exam a medical history and lab tests The second and third visits will involve PET scans and the fourth visit will involve an MRI scan

Participants will be compensated up to 430 for their involvement in this study
Detailed Description: Abnormalities of dopaminergic function have been implicated in a number of neurological and psychiatric illnesses including Parkinsons disease schizophrenia and psychostimulant dependence syndromes Functional imaging with positron emission tomography PET and single photon emission computed tomography SPECT have demonstrated the feasibility of in vivo measurement of the distribution and the density of dopamine DA D1 and D2 receptors in humans Besides simple measurement of receptor density it has been shown that the competition between endogenous neurotransmitters and radiolabeled tracers might provide a tool to estimate extracellular levels of neurotransmitters However most of those studies have been confined to the striatum In this protocol using a PET tracer 18Ffallypride we will estimate both stimulant-induced DA release and baseline DA levels in the striatum and extrastriatal regions by comparing baseline scans and those after d-amphetamine or alpha-methyl-para-tryosine AMPT adminstration In addition to explore genetic factors that determine synaptic DA levels allelic variations of two genes that regulate DA levels catechol-O-methyltransferase and dopamine transporter will be studied

A recent study showed that oral administration of d-amphetamine induced displacement of 11C raclopride in a similar way as the commonly used method of iv administration The current protocol will be performed in two steps First the method of d-amphetamine administration will be determined by studying effects of oral d-amphetamine on the binding of 18F fallypride binding If oral administration effectively displaces the radioligand binding this method will be applied in the subsequent study of examining effects of each of d-amphetamine and AMPT in individual subjects

If this study successfully detects the influence of DA levels on 18Ffallypride binding the same design will be applied to the studies of patients with psychiatric and neurological disorders

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
03-M-0104 None None None