|
PET Imaging of Dopamine in Healthy Study Participants Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on PET Imaging of Dopamine in Healthy Study Participants conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. PET Imaging of Dopamine in Healthy Study Participants Clinical research trials and PET Imaging of Dopamine in Healthy Study Participants healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including PET Imaging of Dopamine in Healthy Study Participants. PET Imaging of Dopamine in Healthy Study Participants Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a PET Imaging of Dopamine in Healthy Study Participants clinical trial. Test subjects oftentimes recieve the best healthcare possible for their PET Imaging of Dopamine in Healthy Study Participants condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "P" Clinical Trials Conditions > PET Imaging of Dopamine in Healthy Study Participants  PET Imaging of Dopamine in Healthy Study Participants
PET Imaging of Dopamine in Healthy Study Participants
For Condition: Healthy
Status: Recruiting
Sponsor(s): National Institute of Mental Health (NIMH) ,
Synopsis: 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.
Details: Abnormalities of dopaminergic function have been implicated in a number of neurological and psychiatric illnesses, including Parkinson's 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 (18F)fallypride, 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 i.v. 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 oral administration is not effective to displace (18F) fallypride binding, the commonly used method of i.v. administration will be used to study effects of d-amphetamine and AMPT as described in the approved protocol. If this study successfully detects the influence of DA levels on (18F)fallypride binding, the same design will be applied to the studies of patients with psychiatric and neurological disorders.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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
Total Enrollment: 45
Location and Contact Information:
National Institute of Mental Health (NIMH) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 030104; 03-M-0104
Study Start Date: June 17, 2003
Record last reviewed: February 17, 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00062946
Other Healthy Studies:
1. Comparison of Immune Response in Normal Volunteers and Patients with Helminth Infections
2. Effect of Hydrocortisone on the Brain
3. Magnesium Effects in Apheresis
4. Comparing Magnetic Resonance Imaging/Spectroscopy Techniques
5. Magnetic Resonance Imaging of the Brain in Emotional Processing
Related Studies:
Other Healthy Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
PET Imaging of Dopamine in Healthy Study Participants
|
|
|
|
|
|
|
|
