The Effects of Dextroamphetamine on Brain Function

NCT ID: NCT00004556

Last Updated: 2018-09-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 108 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 1991-09-30
• Study Completion Date: 2018-09-25

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.

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.

Conditions

Healthy

Eligibility Criteria

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.

Exclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karen F Berman, M.D.

Role: PRINCIPAL_INVESTIGATOR

National Institute of Mental Health (NIMH)

Locations

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, United States

Countries

United States

References

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Reference Type: BACKGROUND

PMID: 8773823 (View on PubMed)

Baxter LR Jr, Schwartz JM, Phelps ME, Mazziotta JC, Guze BH, Selin CE, Gerner RH, Sumida RM. Reduction of prefrontal cortex glucose metabolism common to three types of depression. Arch Gen Psychiatry. 1989 Mar;46(3):243-50. doi: 10.1001/archpsyc.1989.01810030049007.

Reference Type: BACKGROUND

PMID: 2784046 (View on PubMed)

Buchsbaum MS, Wu J, DeLisi LE, Holcomb H, Kessler R, Johnson J, King AC, Hazlett E, Langston K, Post RM. Frontal cortex and basal ganglia metabolic rates assessed by positron emission tomography with [18F]2-deoxyglucose in affective illness. J Affect Disord. 1986 Mar-Apr;10(2):137-52. doi: 10.1016/0165-0327(86)90036-4.

Reference Type: BACKGROUND

PMID: 2941470 (View on PubMed)

Other Identifiers

91-M-0230

Identifier Type: -

Identifier Source: secondary_id

910230

Identifier Type: -

Identifier Source: org_study_id