Protocol Number: 91-M-0230

Title:

Mechanisms of Individual Variation of Dextroamphetamine Effects in Normal Human Subjects

Number:

91-M-0230

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.

Sponsoring Institute:

National Institute of Mental Health (NIMH)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: Yes

Population Exclusion(s): Children

Eligibility Criteria:

INCLUSION CRITERIA:

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.

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.

Special Instructions:

Currently Not Provided

Keywords:

Stimulants

Affect

Cognition

Brain Physiology

Brain Metabolism

Catecholamines

Brain Imaging

Cognitive Efficiency

Dopamine Genes

Recruitment Keyword(s):

None

Condition(s):

Healthy

Investigational Drug(s):

Dextroamphetamine

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Institute of Mental Health

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

The mortality experience of individuals on the Salford Psychiatric Case Register, I- all cause mortality

Reduction of prefrontal cortex glucose metabolism common to three types of depression

Frontal cortex and basal ganglia metabolic rates assessed by positron emission tomography with [18F]2-deoxyglucose in affective illness

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Clinical Research Informatics, CC.

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National Institutes of Health Clinical Center Bethesda, Maryland 20892. Last update: 01/30/2009