NIH Clinical Research Studies

Protocol Number: 03-M-0104

Active Accrual, Protocols Recruiting New Patients

Title:
PET Imaging of Dopamine D2 Receptors and Extracellular Dopamine with (18F)Fallypride, D-amphetamine, and Alpha-Methyl-Para-Tyrosine in Healthy Subjects
Number:
03-M-0104
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.

Sponsoring Institute:
National Institute of Mental Health (NIMH)
Recruitment Detail
Type: Active Accrual Of New Subjects
Gender: Male & Female
Referral Letter Required: No
Population Exclusion(s): Children

Eligibility Criteria:
INCLUSION CRITERIA:

Age 18-45, inclusive

In good general health on basis of history and physical examination

Normal screening laboratory studies including thyroid function tests, blood count, serum electrolytes, liver and kidney function, and urinalysis

Normal ECG at a resting condition

Normal blood pressure

No illegal drug use based on urine drug screen

EXCLUSION CRITERIA:

Pregnancy/Nursing

Evidence of active mental or neurological illness

Medically significant biochemical or hematological abnormality on screening laboratory studies

Abnormal ECG

High Blood Pressure (above 140 systolic and/or above 90 dystolic pressure)

History of myocardial infarction or angina pectoris

Positive urine drug screen or use of alcohol within one week prior to each PET study

History of substance abuse or dependence within 6 months

Presence of ferromagnetic metal in the body or heart pacemaker

Body weight more than 93 kg to limit AMPT dose to 4g/ day (only for subjects having four PET scans and d-amphetamine and AMPT administration)

Claustrophobia

Special Instructions: Currently Not Provided
Keywords:
Thalamus
Cerebral Cortices
Quantification
Reproducibility
Dopamine Release
(18F) Fallypride
D-Amphetamine
Alpha-Methyl-Para-Tyrosine (AMPT)
PET
Dopamine D2 Receptor
Recruitment Keywords:
Healthy Volunteer
HV
Conditions:
Healthy
Investigational Drug(s):
(18F)fallypride
Investigational Device(s):
None

Contacts:
Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:
Abi-Dargham A, Gil R, Krystal J, Baldwin RM, Seibyl JP, Bowers M, van Dyck CH, Charney DS, Innis RB, Laruelle M. Increased striatal dopamine transmission in schizophrenia: confirmation in a second cohort. Am J Psychiatry. 1998 Jun;155(6):761-7. PMID: 9619147

Abi-Dargham A, Rodenhiser J, Printz D, Zea-Ponce Y, Gil R, Kegeles LS, Weiss R, Cooper TB, Mann JJ, Van Heertum RL, Gorman JM, Laruelle M. Increased baseline occupancy of D2 receptors by dopamine in schizophrenia. Proc Natl Acad Sci U S A. 2000 Jul 5;97(14):8104-9. PMID: 10884434

Anand A, Verhoeff P, Seneca N, Zoghbi SS, Seibyl JP, Charney DS, Innis RB. Brain SPECT imaging of amphetamine-induced dopamine release in euthymic bipolar disorder patients. Am J Psychiatry. 2000 Jul;157(7):1108-14. PMID: 10873919

Active Accrual, Protocols Recruiting New Patients

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