Cooperative AgreementPostedDiscretionary

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

National Institutes of Health
PAR-25-446
Application Deadline
Aug 21, 2028
897 days left
Days Remaining
897
Until deadline
Award Ceiling
$3,000,000
Total Program Funding

Grant Opportunity Analysis

The National Institutes of Health (NIH) is offering a funding opportunity titled "Development of Interventions to Prevent and Treat Substance Use Disorders and Overdose (UG3/UH3 - Clinical Trial Optional)" aimed at supporting research into effective interventions for substance use disorders (SUDs) and overdose. This cooperative agreement encourages applications for preclinical and clinical studies focusing on pharmacotherapies, device-based treatments, digital therapeutics, and behavioral interventions, with the goal of advancing these interventions towards regulatory approval or clinical adoption. The funding amount can reach up to $3 million, and applications are due by 5:00 PM local time, with multiple submission cycles from October 2025 to August 2028. Interested applicants can find more information and contact NIH Grants Information at grantsinfo@nih.gov for inquiries.

Eligible Applicants

Others
Additional Eligibility Information

Other Eligible Applicants include the following: Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; U.S. Territory or Possession.

Grant Documents

2 Files
PAR-25-446-Full-Announcement.html
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PAR-25-446.html
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AI Summary
The Department of Health and Human Services (HHS), through the National Institute on Drug Abuse (NIDA) at NIH, has reissued a funding opportunity (PAR-25-446) for research into interventions preventing and treating substance use disorders (SUDs) and overdose. This UG3/UH3 cooperative agreement supports preclinical and clinical studies focusing on pharmacotherapies, device-based treatments, digital therapeutics (DTx), and behavioral interventions (Stages I-III). The goal is to advance candidate interventions towards regulatory approval or clinical adoption, addressing the urgent need for effective SUD treatments. Applications are due by 5:00 PM local time, with multiple cycles from October 2025 to August 2028. Eligibility extends to various organizations, including foreign entities, but excludes applications with foreign subawards/subcontracts. Substantial NIH involvement is expected, with clear milestones required for UG3/UH3 phase transitions. Applications that don't focus on novel target identification, mechanistic studies of addiction neurobiology, alcohol as the sole substance, or behavioral interventions beyond Stage III are not responsive.

Related Grant Opportunities

Project Timeline

postedOriginal Opportunity PostedSep 10, 2025
deadlineApplication DeadlineAug 21, 2028
expiryArchive DateSep 26, 2028

Funding Details

Award Ceiling
$3,000,000
No cost sharing required

Agency & Classification

Agency
National Institutes of Health(HHS-NIH11)
Funding Category
Health
Funding Instrument
Cooperative Agreement

Grantor Contact

CFDA Numbers

93.279

Official Sources