USDOE Human Subjects Research Database, fiscal year 1995

Brookhaven National Laboratory

Project Identifier: BNL-88-216

Project Title:

A Study of Carbon-11-Cocaine Binding in Human Brain and Heart

Principle Investigator: Dr. Joanna S. Fowler

Project started in: 1988

Fiscal Year 1995 Funding for Research on Human Subjects:

Project Funding Information:
Project did not receive funding in Fiscal Year 1995.
Project did not use human subjects in Fiscal Year 1995.

Explanation:

DOE/OHER funded this project, but no human subjects were studied during the reporting period.

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: October 04, 1995

Number of Human Subjects in the Last Reporting Period for this Project: 0
(Reporting periods vary.)

Type of Human Subjects Involvement:

Ionizing Radiation and Radioactive Substances:

External use of ionizing radiation on human subjects.

• For clinical research.

Internal administration of radioactive substances to human subjects.

• For clinical research.

Collection of Bodily Materials:

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

• Use of bodily materials collected from subjects specifically for this project.

(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])

This project involves the use of 11-C-cocaine to assess the following: 1) pharmacokinetics of cocaine in human brain and heart in normal controls and cocaine abusers; and 2) the use of 11-C-cocaine as a ligand to monitor the dopamine transporter in the presynaptic dopamine neuron. This tracer is used to assess neuronal mass to determine the extent of presynaptic dopamine degeneration. There are no pharmacological effects from the cocaine. This project studies normal controls, cocaine abusers, and patients with Parkinson's disease or schizophrenia. Most subjects will have repeat studies after a three month interval. Approximately 15 subjects per year will be studied. After C-11-cocaine administration, the subjects are subsequently scanned with positron emission tomography (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 the doses as low as those delivered in this procedure has been reported. The estimation of risk of harm can be obtained only by extrapolation from much higher doses. 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 injected by venipuncture, there is minor discomfort and a slight possibility of local bleeding in the tissues.