Completed

Mechanisms of Individual Variation of Dextroamphetamine Effects in Normal Human Subjects

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What is being collected

Data Collection

Who is being recruted

From 18 to 45 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Observational
Study Start: September 1991
See protocol details

Summary

Principal SponsorNational Institute of Mental Health (NIMH)
Last updated: September 28, 2018
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Study start date: September 30, 1991

Actual date on which the first participant was enrolled.

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.

NCT00004556
Principal SponsorNational Institute of Mental Health (NIMH)
Last updated: September 28, 2018
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

108 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 45 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

3 inclusion criteria required to participate
Age range: 18-45 years

No Axis I or Axis II diagnosis

Prior participation as a normal volunteer under NIH protocol # 95-M-0150

3 exclusion criteria prevent from participating
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

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

Subjects with an Axis I or II disorder will be excluded

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, United StatesOpen National Institutes of Health Clinical Center, 9000 Rockville Pike in Google Maps
CompletedOne Study Center