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

Active
Yes
Status
Posted
Published Date
September 1st, 2022
Close Date
September 1st, 2025
Award Ceiling
$3,000,000.00
Opportunity No.
PAR-22-200

Agency

National Institutes of Health (HHS-NIH11)

Eligible Applicants

Others

Funding Category

Health

Funding Instrument

Cooperative Agreement

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes

Summary

The National Institutes of Health is offering a federal grant opportunity titled "Development of Medications to Prevent and Treat Opioid and/or Stimulant Use Disorders and Overdose (UG3/UH3 - Clinical Trial Optional)". This grant aims to support the discovery and development of medications to prevent and treat opioid and/or psychostimulant use disorders and overdose. The funding instrument type for this opportunity is a Cooperative Agreement. The grant falls under the category of funding activity related to health. The grant does not require cost sharing or matching. The eligible applicants for this grant include various institutions and organizations such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), Eligible Agencies of the Federal Government, Faith-based or Community-based Organizations, Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Indian/Native American Tribal Governments (Other than Federally Recognized), Non-domestic (non-U.S.) Entities (Foreign Organizations), Regional Organizations, Tribally Controlled Colleges and Universities (TCCUs), and U.S. Territory or Possession. The purpose of this grant is to support the discovery and development of medications that can prevent and treat opioid and/or psychostimulant use disorders and overdose. The grant involves two phases, UG3 and UH3. The UG3 phase provides support for a project with specific milestones to be accomplished within a 2-year period. The UH3 phase provides funding for 3 years to a project that successfully completes the milestones set in the UG3 phase. Projects that meet their milestones in the UG3 phase will be considered for transition to the UH3 phase. The grant encourages applications that include preclinical or clinical research studies with high impact and quick results to advance medications closer to FDA approval for the prevention and treatment of opioid use disorders and overdose. The compounds to be evaluated can be small molecules or biologics, and they can be tested in pre-clinical models or for the clinical manifestations of opioid use disorders such as withdrawal, craving, relapse, or overdose. The grant also supports 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 opioid use disorders and overdose. The goal of this grant is to fast-track the discovery and development of medications to prevent and treat opioid use disorders or opioid overdose and advance them in the FDA's drug development approval pipeline. For more information and to apply for this grant opportunity, please visit the following link: Development of Medications to Prevent and Treat Opioid and/or Stimulant Use Disorders and Overdose (UG3/UH3 - Clinical Trial Optional). If you have any inquiries, you can contact NIH Grants Information at grantsinfo@nih.gov.

Description

The purpose of this Funding Opportunity Announcement is to support the discovery and development of medications to prevent and treat opioid and/or psychostimulant 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. 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. 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 OUDs and overdose. 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 OUDs 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 OUDs and overdose. Through this FOA, NIDA seeks to fast-track the discovery and development of medications to prevent and treat OUDs or opioid overdose and to advance them in the FDA's drug development approval pipeline.

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