The Effects of Dextroamphetamine on Brain Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004556
Recruitment Status : Completed
First Posted : February 9, 2000
Last Update Posted : September 28, 2018
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )

Brief Summary:

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.

Condition or disease

Detailed Description:
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 and varying rewards, 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.

Study Type : Observational
Actual Enrollment : 108 participants
Official Title: Mechanisms of Individual Variation of Dextroamphetamine Effects in Normal Human Subjects
Study Start Date : September 30, 1991
Study Completion Date : September 25, 2018

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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Normal volunteers will be recruited exclusively from among individuals who have volunteered for studies under protocol 95-M-0150 as normal control subjects and for whom genetic data is already available. Subjects will satisfy the inclusion/exclusion criteria for that protocol before being given an opportunity to volunteer under this protocol. Here we detail criteria that are specific to this protocol, per se.

Inclusion criteria:

  1. Prior participation as a normal volunteer under NIH protocol # 95-M-0150.
  2. No Axis I or Axis II diagnosis.
  3. Age range: 18-45 years.


  1. Subjects with an Axis I or II disorder will be excluded.
  2. Subjects with a history of cardiovascular disease and other medical illnesses, substance abuse or recreational drug use, and hypertension will be excluded. An electrocardiogram, blood pressure and pulse rate will be checked on all subjects prior to participation in the study.
  3. Pregnant women. Women of childbearing potential will undergo a urine pregnancy test the day of the study and screened by history for the possibility of pregnancy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00004556

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institute of Mental Health (NIMH)
Principal Investigator: Karen F Berman, M.D. National Institute of Mental Health (NIMH)

Responsible Party: National Institute of Mental Health (NIMH) Identifier: NCT00004556     History of Changes
Other Study ID Numbers: 910230
First Posted: February 9, 2000    Key Record Dates
Last Update Posted: September 28, 2018
Last Verified: September 25, 2018

Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) ):
Brain Physiology
Brain Metabolism
Brain Imaging
Cognitive Efficiency
Dopamine Genes

Additional relevant MeSH terms:
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents