Notice Number: NOT-DA-13-011

Key Dates
Release Date: December 20, 2012

Issued by
National Institute on Drug Abuse (NIDA)

Purpose

This Notice issued by the National Institute on Drug Abuse is to clarify the Funding Opportunity Description of PAR-12-239 "Clinical Development of Minimally-Invasive Bioassays to Support Outpatient Clinical Trials of Therapeutics for Substance Use Disorders (R01)".

Section I. Funding Opportunity Description - Original

Clinical trials evaluating the efficacy of medications to treat Substance Use Disorders (SUDs) are limited by two major issues:  a) the inability to accurately and quantitatively monitor the frequency and level of a subject’s illicit drug exposure and b) uncertainty in assessing the level of a subject’s adherence to the trial medication regimen.

Section I. Funding Opportunity Description - Revised

Clinical trials evaluating the efficacy of medications to treat Substance Use Disorders (SUDs) are limited by two major issues:  a) the inability to accurately and quantitatively monitor the frequency and level of a subject’s illicit drug exposure and b) uncertainty in assessing the level of a subject’s adherence to the trial medication regimen. Applications submitted to this opportunity should focus around an outpatient clinical trial, with or without preclinical system development studies. Applications not seeking to test a minimally invasive bioassay system in a clinical trial are not appropriate for this opportunity.

All other aspects of this FOA remain the same.

Inquiries

Please direct all inquiries to:

Aidan Hampson PhD.
Program Officer, Medications Research Grants Branch
Division of Pharmacotherapies and Medical Consequences of Drug Abuse
National Institute on Drug Abuse (NIDA)
National Institutes of Health
6001 Executive Blvd, Rockville 20852
Telephone: 301-443-8039
FAX: 301-443-9649
Email: [email protected]