Development of Clinical Outcome Assessments as New FDA-Qualified Drug Development Tools to Accelerate Therapeutics Development for Opioid and Stimulant Use Disorders (UG3/UH3 Clinical Trial Optional) - RFA-DA-25-028
Funder
National Institutes of Health
LOI Deadline
LOI Required
Recommended, but not required
Application Deadline
Funding Amount
$2,500,000.00
Maximum Project Duration
5 years
Research Focus Areas
Substance Use/Misuse/Addiction
Alcohol
Research Methods
Randomized Control Trials (RCT)
Description
The purpose of this funding opportunity is to support the development of Clinical Outcome Assessments (COA) for Substance Use Disorders (SUD). The COA development plan is expected to progress into the FDA Drug Development Tool Qualification Program. This notice of funding opportunity (NOFO) utilizes the UG3/UH3 Phased Innovation Awards Cooperative Agreement grant mechanism that includes two phases. The applications responding to this NOFO should contain a COA development plan that will cover both UG3 and UH3 phases. In the first 2-year UG3 phase the project must have a set of operational milestones to be completed by the end of this period. Once NIDA program has evaluated the progress of the UG3 phase and determined that the UG3 phase has been successfully completed, it transitions to the UH3 phase to be funded for three additional years. The goal of this NOFO is to expand the armamentarium of COA that are FDA qualified as drug development tool (DDT) in the context of use (COI) of a SUD. Achieving this goal will greatly facilitate the development of treatments for SUDs.