Development of Interventions to Prevent and Treat Substance Use Disorders and Overdose (UG3/UH3 – Clinical Trial Optional)
🏛 National Institutes of Health (HHS-NIH11)
✓ Free, no account · Source: Grants.gov · Last verified Oct 18, 2026
Can you apply?
This grant is for research organizations, academic institutions, and nonprofits seeking to develop innovative interventions for substance use disorder (SUD) prevention and treatment, including overdose response. The UG3/UH3 mechanism follows a two-phase structure: a planning/feasibility phase (UG3) followed by optional implementation as a clinical trial (UH3). Applicants must demonstrate institutional research capacity, access to study populations or clinical settings, and a credible preliminary evidence base for their intervention. This program supports early-stage research through implementation, with geographic scope nationwide. Activities supported include intervention development, feasibility testing, and optionally, clinical trial execution. Federal funding is available for research institutions, universities, and organizations with established research infrastructure.
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Program description
The purpose of this Funding Opportunity (NOFO) is to solicit grant applications to support research on the discovery and development of interventions to prevent and/or treat substance use disorders (SUDs) and overdose, including medications and medical devices to treat co-morbid SUDs. This includes preclinical and clinical research studies that will have high impact and quickly yield the necessary results to advance candidate interventions closer to regulatory approval or clinical adoption. This NOFO will utilize the UG3/UH3 activity code.
Who can apply
Eligible applicants
- 501(c)(3) Public Charity
- City / Municipal Government
- Community Health Center
- County Government
- Nonprofits
- Private University
- Public Authority
- Public K-12 School
- Public University
- Small Business (SBA-defined)
- Special District
- State Government
- Tribal Nation
- Tribal Organization
Demographic focus
How to apply
Application links
Required documents
- SF-424 (R&R) form and other PHS forms (PHS 398 or R&R application package)
- Project Narrative (research strategy) including significance, innovation, and approach
- Preliminary data, published or in-press manuscripts, or letters of support
- Budget and budget justification (including personnel, equipment, and indirect costs)
- Letters of institutional support and collaboration from clinical sites or community partners
- Biographical sketches of key personnel (NIH format)
- Current and pending support documentation
- Data management and sharing plan
- (Optional) Human subjects protection documentation if clinical populations are involved
Program contact
- 👤 National Institutes of Health
- 📧 grantsinfo@nih.gov
- 📞 301-402-2541
Funding track record
Recent awards under CFDA 93.279 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
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$976,983,003
-
$204,359,786
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$128,377,094
-
$126,585,435
-
$99,478,296
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$79,333,238
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$78,245,057
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$74,806,844
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$71,588,047
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$61,572,673
Top States by Funding
- NC 2 awards $1,006.2M
- NY 4 awards $261.1M
- WA 1 awards $204.4M
- CT 2 awards $155.8M
- CA 4 awards $141.9M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.279). How funding has trended year over year.
| 2024 | $1,245,503,136 | |
| 2025 | $1,343,517,098 | |
| 2026 est. | $20,194,375 |
FAQ
Who is eligible to apply for this grant?
Research institutions, academic medical centers, colleges, universities, and nonprofit organizations with research capacity and institutional research infrastructure may apply. For-profit entities can apply but face restrictions. Applicants should have access to relevant study populations or treatment settings.
What is the UG3/UH3 mechanism, and how does the two-phase process work?
The UG3 phase supports planning, intervention development, and feasibility testing. Successful UG3 awardees may then apply for a UH3 award to conduct a full clinical trial of their intervention, though clinical trial participation is optional.
What types of interventions are funded under this grant?
This program supports development of novel behavioral, pharmacological, technological, or policy-level interventions to prevent substance use disorders, treat existing disorders, or reduce overdose risk. Interventions must address prevention, treatment, recovery, or harm reduction.
How competitive is this grant, and what funding should I expect?
NIH research grants are highly competitive; applicants typically need published preliminary data, strong institutional support, and feasible timelines. Funding amounts vary but UG3 awards typically range from $200,000–$500,000 total costs over 2-3 years.
What is the deadline, and how long does review take?
The next deadline is August 21, 2028, with applications opening September 10, 2025. NIH peer review typically takes 4–6 months, with funding decisions communicated 6–9 months after submission.
💡 Tips for applicants
- Build strong preliminary data: Demonstrate feasibility through pilot studies, literature review, or preliminary implementation evidence. NIH reviewers want to see that your intervention is grounded in existing research and has realistic promise.
- Secure institutional support and committed collaborators: Include letters of support from clinical sites, treatment providers, or community partners who will facilitate recruitment and implementation. Show that partner organizations are genuinely invested.
- Focus on feasibility and go/no-go criteria: Especially for the UG3 phase, clearly define what you will learn and what metrics will determine whether to proceed to a clinical trial. Frame your project as intentional risk-mitigation.
- Address health disparities and equity: Discuss how your intervention will reach underserved populations with high SUD burden (rural communities, racial/ethnic minorities, criminal justice-involved individuals). Demonstrate cultural adaptation or accessibility.
- Use the optional clinical trial pathway strategically: If you're not ready for a full trial, the UG3-only pathway is legitimate. Don't overcommit to a UH3 phase just to look ambitious; reviewers respect honest scope.
⚠️ Common mistakes
Many applications fail because they lack sufficient preliminary data or realistic timelines for the planned activities. Reviewers often reject proposals that are too ambitious for the UG3 phase or that lack clear partnership agreements and community engagement plans. Applicants frequently underestimate the complexity of recruitment, retention, or implementation fidelity monitoring, which undermines feasibility and credibility.
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