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Grand Opportunity in Medications Development for Substance-Use Disorders (U01 Clinical Trial Optional)

Agency: National Institutes of Health

Assistance Listings: 93.279 -- Drug Use and Addiction Research Programs

Last Updated: March 31, 2025

The purpose of this notice of Funding Opportunity (NOFO) is to accelerate the development of medication for the treatment of Substance Use Disorders (SUDs) by encouraging research applications to support a broad array of preclinical and/or clinical research projects. The goal is to fund medication studies that will have high impact and quickly yield the necessary results to advance medications closer to FDA approval. It is expected that these U01s will be short-term (funded for up to 3 years) and large (up to $5 million per year) cooperative agreements with close monitoring and significant scientific involvement of NIDA staff. This funding opportunity will enable critical medications development studies that would not be feasible using the traditional R01 activity code.

Eligibility

Eligible applicants

Government

  • County governments
  • Federally recognized Native American tribal governments
  • State governments
  • Special district governments
  • City or township governments
  • Public and Indian housing authorities

Education

  • Public and state institutions of higher education
  • Independent school districts
  • Private institutions of higher education

Miscellaneous

  • Other

Business

  • Small businesses
  • For-profit organizations other than small businesses

Nonprofit

  • Other Native American tribal organizations
  • Nonprofits non-higher education with 501(c)(3)
  • Nonprofits non-higher education without 501(c)(3)

Additional information

Other Eligible Applicants include the following: 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) ; U.S. Territory or Possession.

Grantor contact information

Description

NIH Grants Information grantsinfo@nih.gov

Email

See Section VII. Agency Contacts within the full opportunity announcement for all other inquires.

grantsinfo@nih.gov

Documents

File nameDescriptionLast updated
PAR-25-328-Full-Announcement.html
PAR-25-328 Full Announcement Text
Jan 3, 2025 03:19 PM UTC

Link to additional information

https://grants.nih.gov/grants/guide/pa-files/PAR-25-328.html

Closed: August 11, 2025

Application process

This site is a work in progress. Go to www.grants.gov to apply, track application status, and subscribe to updates.

Award

$--

Program Funding

--

Expected awards

$--

Award Minimum

$5,000,000

Award Maximum

Funding opportunity number:

PAR-25-328

Cost sharing or matching requirement:

No

Funding instrument type:

Cooperative agreement

Opportunity Category:

Discretionary

Opportunity Category Explanation:

--

Category of Funding Activity:

Education

Health

Category Explanation:

--

History

Version:

2

Posted date:

January 3, 2025

Archive date:

September 16, 2025

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