Development of Medications to Prevent and Treat Substance Use Disorders and Overdose (UG3/UH3 - Clinical Trial Optional)

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The purpose of this Notice of Funding Opportunity (NOFO) is to support the discovery and development of medications to prevent and treat substance use disorders (SUDs) and overdose. The UG3/UH3 Phase Innovation Awards Cooperative Agreement involves 2 phases. The UG3 is to support a project with specific milestones to be accomplished by the end of the 2-year period. The UH3 is to provide funding for 3 years to a project that successfully completed the milestones set in the UG3. UG3 projects that have met their milestones will be administratively considered by NIDA and prioritized for transition to the UH3 phase. Investigators responding to this NOFO must address both UG3 and UH3 phases. Application may include preclinical or clinical research studies that will have high impact and quickly yield the necessary results to advance closer to FDA approval medications that are safe and effective to prevent and treat SUDs and overdose. The compounds to be evaluated can be small molecules, biologics, or natural products. They can be tested in pre-clinical models and/or for the clinical manifestations of SUDs such as withdrawal, craving, relapse, or overdose. Applications may focus on the development of new chemical entities, new formulations of marketed medications available for other indications, or combinations of medications that hold promise for the treatment of SUDs and overdose. Through this NOFO, NIDA seeks to fast-track the discovery and development of medications to prevent and treat SUDs or overdose and to advance them in the FDA's drug development approval pipeline.