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The Effects of Dextroamphetamine on Brain Function



The Effects of Dextroamphetamine on Brain Function

For Condition: Healthy
Status: Recruiting
Sponsor(s): National Institute of Mental Health (NIMH) ,
Synopsis: The purpose of this study is to determine the effects of the drug dextroamphetamine on the brain function and mood of healthy volunteers. Monoaminergic drugs are substances that affect the nervous system; these drugs can raise, hamper, or have no effect on brain function when given to healthy individuals. Different responses to a drug may be the result of genetic variations. This study will examine the effects of the monoaminergic drug dextroamphetamine on thought and sensorimotor processes while participants perform a variety of tasks. Participants in this study will undergo a medical history, physical examination, blood tests, and an electrocardiogram (EKG). Women of reproductive potential will undergo a pregnancy test. Participants will be given either dextroamphetamine or placebo (an inactive solution) on two occasions separated by at least 3 to 7 days. Participants will then perform neuropsychological tests that will measure attention, problem solving, memory, and ability to complete simple motor tasks.
Details: Neuropharmacological intervention with monoaminergic drugs in healthy subjects can either augment, have no effect, or hamper brain function. We hypothesize that these population differences might be related to differences (high vs. low) in monoaminergic synaptic function which may be due to specific allelic variations in monoamine system genes (e.g., various synaptic proteins, synthetic enzymes, etc.). We wish to examine the effect of dextroamphetamine, a non-specific monoaminergic drug, on cognitive efficiency while subjects perform a variety of tasks including memory challenges with increasing cognitive load, selective attention and emotional processing. Further, in collaboration with other NIMH neuroimaging protocols, we wish to examine the neurophysiological correlates of these effects. We believe this protocol will provide a matrix for many investigations to elucidate important neurophysiological mechanisms that underlie normal cognition and cognitive efficiency. It is anticipated that these studies would be of potential 'pharmacogenetic' importance with regard to individual differences in the metabolism of monoaminergic drugs in normal health, aging and in disease.
Eligibility:
Study Type:
  Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Age range: 18 to 40 years. Prior participation as a normal volunteer under NIH protocol #95-M-0150. EXCLUSION CRITERIA: No Axis I or Axis II diagnosis. Subjects with a history of cardiovascular disease and other medical illnesses, substance abuse or recreational drug use, and hypertension will be excluded. Women must not be pregnant.
Total Enrollment: 138

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:
  910230;  91-M-0230
Study Start Date: September 27, 1991
Record last reviewed: November 5, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004556

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