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U.S. Department of Health and Human Services

About FDA

Mechanisms of Monoamine Neurotoxicity

Description: Defining mechanisms of CNS stimulant toxicity. This study is a collaborative effort with CDER.

Definition: Norepinephrine functions as both a hormone and a neurotransmitter. As a hormone, it underlies the flight-or-fight response. As a drug it will increase blood pressure. One element in this study involves an examination of how norepinphrine affects the genome.

Another element of this study is the acquisition and use of a confocal microscope which will allow researchers to obtain higher quality microscopic images with the ability to reconstruct three-dimensional images.

These studies will provide information on ways to minimize risk associated with the use of CNS stimulants.

Public Health Outcome: These studies will provide information on ways to minimize risk associated with the use of CNS stimulants.

Accomplishment: An in depth look at the effect of amphetamines (AMPH) and environmentally-induced hyperthermia (EIH) revealed the underpinnings of how and why damage to the brain occurs. Varying patterns of brain damage are seen upon exposure of AMPH versus EIH.

1. Genomic Evaluation of CNS Blood Vessels

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

a. Complete study on genomic evaluation of norepinephrine modulation of CNS blood vessels

10/31/2009

Completed 11/15/2009

b. Complete assessment of research findings

11/15/2010

Completed 11/15/2010

c. Develop draft technical report/manuscript/publication on genomic evaluation of norepinephrine modulation of CNS blood vessels

12/1/2010

Completed 12/1/2010

d. Complete the peer review (NCTR and other FDA researchers) of draft technical report, manuscript, and/or publication

2/1/2011

Completed 3/4/2011

e. Obtain NCTR Center Director approval on the draft technical report, manuscript, and/or publication via the document tracking system

3/1/2011

Completed 2/15/2012

f. Submit final technical report, manuscript, and/or publication on genomic evaluation of norepinephrine modulation of CNS blood vessels to a scientific journal

5/15/2012

(FY13 Q2)

Completed 5/15/2013

Footnotes

  • The dates in italics under the milestone due dates are modified milestone due dates which had to be updated due to real-time delays. The milestone status reflects the revised dates.

2. Amphetamine and Methamphetamine Studies

This project was terminated due to an unacceptably high risk to laboratory animals.

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

a. Submit protocol for remote monitoring for comparing the effects on body temperature and blood pressure in laboratory animals exposed to amphetamine or methamphetamine

3/31/2010

Completed 3/24/2010

b. Write and submit protocol for concept that studies comparing the neurotoxicology of amphetamine with methamphetamine and methylphenidate

7/31/2010

Completed 6/14/2010

c. Complete evaluation and development of standard operating procedure on specialized testing equipment

6/1/2011

Completed 6/1/2011

d. Complete initial research on the effects on body temperature and blood pressure in animals exposed to amphetamine or methamphetamine

11/30/2011

Completed Canceled

e. Complete assessment/interpretation of research findings

12/1/2012

Completed Canceled

f. Develop draft technical report/manuscript/publication on the effects on body temperature and blood pressure in laboratory animals exposed to amphetamine or methamphetamine

4/15/2013

Completed Canceled

g. Complete the peer review (NCTR and other FDA researchers) of draft technical report, manuscript, and/or publication

6/15/2013

Completed Canceled

h. Submit final technical report, manuscript, and/or publication on the effects on body temperature and blood pressure in animals exposed to amphetamine or methamphetamine

10/15/2013

Completed Canceled

Key Projects Legend

Milestone StatusDefinition
Not Yet StartedWork for specific milestone has not yet been started.
CompletedMilestone and/or overall project is completed.
On TrackMilestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On HoldMilestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
DelayedMilestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status.

Glossary

CNS

Central Nervous System

CDER

Center for Drug Evaluation and Research

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.