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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.

1. Genomic Evaluation of CNS Blood Vessels

Briefing Status: ON TRACK

Prior Briefing Status: ON TRACK

Milestone Description	Milestone Date	Milestone Status	Milestone 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)	On Track

2. Amphetamine and Methamphetamine Studies

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

Milestone Description	Milestone Date	Milestone Status	Milestone 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 Status	Definition
Not Yet Started	Work for specific milestone has not yet been started.
Completed	Milestone and/or overall project is completed.
On Track	Milestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On Hold	Milestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
Delayed	Milestone - 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.