Fast-Track Development of Medications to Treat Cannabis Use Disorders (UG3/UH3 Clinical Trial Optional)

Funder: National Institutes of Health

Due Date: 5/7/2018

Budget: $3,000,000

Opportunity: PAR-18-221

The purpose of this Funding Opportunity Announcement (FOA) is to accelerate the discovery and development of medications to treat Cannabis Use Disorders (CUDs) using the UG3/UH3 mechanism. The objective is to advance medications toward the ultimate goal of obtaining FDA approval. Advances in understanding the cannabinoid systems and the effects of marijuana on the brain, coupled with the availability of both novel and marketed medications that may be efficacious to treat these disorders, offer unprecedented opportunities to develop safe and effective pharmacotherapies for CUDs.

The compounds to be evaluated can be small molecules or biologics.  They can be tested in pre-clinical models and/or for the clinical manifestations of CUDs or their consequences such as withdrawal, craving, or cannabis use relapse. 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 CUDs.

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 FOA must address both UG3 and UH3 phases.

Through this FOA, NIDA seeks to fast-track the discovery and development of pharmacotherapies for CUDs and to advance them in the FDA’s drug development approval pipeline.

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