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Notice of Special Interest (NOSI): HEAL Initiative: Development of Medications to Prevent and Treat Opioid and/or Stimulant Use Disorders and Overdose

National Institutes of Health

The NIH HEAL initiative aims to speed the development and implementation of scientific solutions to the national opioid public health crisis by bolstering research across NIH to (1) improve treatment for opioid and co-occurring stimulant misuse and addiction and (2) enhance pain management. More information and periodic updates about the HEAL Initiative are available at: https://heal.nih.gov/ .

PAR-22-200 entitled Development of Medications to Prevent and Treat Opioid and/or Psychostimulant Use Disorders and Overdose (UG3/UH3 - Clinical Trial Optional seeks to support the discovery and development of medications to prevent and treat Opioid and/or Stimulant Use Disorders 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 Phase. 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.

The purpose of this Notice of Special Interest (NOSI) is to seek research applications that focus on the scientific scope of the Helping to End Addition Long-term (HEAL) initiative (https://heal.nih.gov/) to be submitted under the PAR-22-200 titled "Development of Medications to Prevent and Treat Opioid and/or Stimulant Use Disorders and Overdose (UG3/UH3 - Clinical Trial Optional)".

Grant applications may seek support for an array of preclinical and/or clinical research projects. They can include the evaluation of new chemical entities (NCEs), already-marketed medications, biologics (i.e., vaccines, antibodies, enzymes, gene therapies, etc.), combinations of medications, and/or new medication delivery devices/technologies. The goal of the NOSI is to advance the development towards FDA approval of safe and effective medications to prevent or treat opioid and/or psychostimulant use disorders.

This notice applies to due dates on or after October 27, 2022 and subsequent receipt dates through September 2, 2025.

NOT-DA-23-010