The contractor is to obtain pharmacokinetic and pharmacodynamic information of new medications. Such information is essential for the development of effective pharmacotherapies for the treatment of drug addiction. As medications are often taken with alcohol and/or other drugs, clinical studies shall also be carried out to investigate the nature of the interaction. This project involves recruiting and dosing subjects, collecting biological samples (blood, urine, feces, saliva, hair, sweat, etc.), developing and validating analytical methods, identifying metabolites, quantifying drugs/metabolites in biological samples, monitoring pharmacological responses, and performing statistical, pharmacokinetic and pharmacodynamic analyses of the data. Pharmacokinetic parameters, such as bioavailability, volume of distribution, protein-binding, clearance and half-life shall be determined. The correlation of pharmacological responses with plasma drug level/pharmacokinetic parameters shall be investigated. Specific details for each project (protocol) must be approved by the NIDA Project Officer prior to initiation of each project. All studies must be carried out under pertinent FDA regulations, such as current Good Clinical Practice (cGCP) and current Good Laboratory Practice (cGLP) regulations. The data obtained on the pharmacokinetics and pharmacodynamics of new medications shall be adequate in form and substance for submission to the Food and Drug Administration (FDA) in support of IND and NDA applications.

Agency
National Institute of Health (NIH)
Institute
National Institute on Drug Abuse (NIDA)
Type
Research and Development Contracts (N01)
Project #
N01DA048306-004
Application #
2306418
Study Section
Project Start
1994-06-30
Project End
1997-06-29
Budget Start
1995-06-28
Budget End
1996-09-29
Support Year
Fiscal Year
1995
Total Cost
Indirect Cost
Name
University of California San Francisco
Department
Psychiatry
Type
Schools of Medicine
DUNS #
073133571
City
San Francisco
State
CA
Country
United States
Zip Code
94143
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Houtsmuller, Elisabeth J; Notes, Lisa D; Newton, Thomas et al. (2004) Transdermal selegiline and intravenous cocaine: safety and interactions. Psychopharmacology (Berl) 172:31-40
Uemura, Naoto; Nath, Rajneesh P; Harkey, Martha R et al. (2004) Cocaine levels in sweat collection patches vary by location of patch placement and decline over time. J Anal Toxicol 28:253-9