USDOE Human Subjects Research Database, fiscal year 1995

Brookhaven National Laboratory


Project Identification:

Project Identifier: BNL-92-243

Project Title:

Dopamine D2 Receptor Availability Measured with Carbon-11-Labeled Raclopride

Principle Investigator: Dr. Steven L. Dewey

Project started in: 1992


Fiscal Year 1995 Funding for Research on Human Subjects:

Project Funding Information:
Project received funding in Fiscal Year 1995.
Project used human subjects in Fiscal Year 1995.

Funding Sources:

DOE: Office of Health and Environmental Research (OHER)
Amount: $212,000 (Est.)

Non-DOE Federal: National Institute on Drug Abuse (NIDA)
Amount: $156,000 (Est.)
Comments:
DA 06891

Total Funding: $368,000


Information on Use of Human Subjects:

Project does not involve use of multiple protocols/subprojects.

IRB Review:
Type of Review: Full Board
Most Recent Approval: January 04, 1995

Number of Human Subjects in the Last Reporting Period for this Project: 23
(Reporting periods vary.)

Type of Human Subjects Involvement:

Ionizing Radiation and Radioactive Substances:

External use of ionizing radiation on human subjects.

Internal administration of radioactive substances to human subjects.

Chemical Substances:

Internal use of chemical substances (solid, liquid, or gas) in human subjects.

Collection of Bodily Materials:

Collection of personally identifiable bodily materials (blood or blood products, cells, tissue, organs, waste).

Abstract:
(a. Objectives, b. Methodology, c. Ionizing Radiation, Radioactive Substances, or Chemical Substances to which human subjects are exposed, d. Involvement of Human Subjects [d.1. procedures used, d.2. risks if any])

These studies are designed to assess the availability of the dopamine D2 receptor in the human brain as it relates to the concentration of endogenous dopamine. The radiotracer, 11-C-raclopride, has been shown to be sensitive to changes in endogenous dopamine and we will use this reaction to probe the effects of changes in endogenous dopamine that are induced by different drugs using high resolution positron emission tomography (PET). The studies may provide insight into the mechanisms of actions of these drugs and may also help us understand the interactions that exist between the dopaminergic system and other systems that are anatomically linked to it. Approximately 15 normal volunteers, 15 alcoholic patients, 15 psychiatric patients, and 15 cocaine abusers will be studied using 11-C-raclopride and methylphenidate. The subjects will be males between the ages of 18-85. The subjects will have the short-lived positron emitter tracer (C-11-raclopride) administered intravenously and then be scanned with PET.

A potential side effect of radiation is the induction of cancer. However, no harm in a human individual or in a large population exposed at doses as low as those delivered in this procedure has been reported. The estimation of risk of harm can be obtained only from extrapolation from much higher doses. Methylphenidate is a mild central nervous system stimulant used to treat attention deficit disorder and narcolepsy. It increases heart rate and blood pressure and can cause a behavioral high. It can also elicit negative feelings of anxiety. In the event that either cardiovascular or behavioral complications occur, they can be effectively treated with an intramuscular injection of a neuroleptic. Since methylphenidate will be administered intravenously, the likelihood of cardiac stimulation is higher. There is also some evidence that methylphenidate may lower the seizure threshold in some individuals with no history of seizure disorders. Therefore, methylphenidate should not be given to patients with cardiac disease or patients with a past history of seizure disorders. Arterial catheterization has the following rare, but possible complications: pain during placement of the catheter, a risk of bleeding at the skin puncture site, the possibility of local infection and temporary or permanent impairment of the blood supply to portions of the hand. Whenever blood is removed or a substance is injected by venipuncture, there is minor discomfort and a slight possibility of local bleeding in the tissues.


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