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

Funder: National Institutes of Health

Due Dates: April 10, 2025 (Application) | August 11, 2025 (Application) | March 11, 2025 & July 12, 2025 (Letters of Intent) | August 12, 2025 (Expiration)

Funding Amounts: Up to $5 million/year (direct costs) for up to 3 years; cooperative agreement (U01); NIH anticipates ~5 awards/year.

Summary: Large, short-term grants to accelerate preclinical and clinical research advancing medications for substance use disorders toward FDA approval.

Key Information: Clinical trial proposals are allowed but not required; close NIDA involvement and milestone-driven progress are expected.

Description

This opportunity, offered by the National Institute on Drug Abuse (NIDA) at NIH, aims to accelerate the development of safe and effective medications for the treatment of Substance Use Disorders (SUDs). The program supports a broad range of preclinical and/or clinical research projects, including lead optimization, preclinical studies, and Phase I–III clinical trials. The focus is on high-impact studies that can rapidly advance candidate medications toward FDA approval, especially those not feasible under traditional NIH R01 mechanisms.

Projects may address any illicit substance (e.g., opioids, methamphetamine, cocaine, nicotine, cannabis), and can include new chemical entities, repurposed drugs, biologics (e.g., vaccines, antibodies, gene therapies), drug combinations, or novel delivery technologies. Use of AI/ML tools in drug development is encouraged. NIDA staff will be actively involved in the scientific direction and oversight of funded projects.

Due Dates

Letter of Intent (strongly encouraged):
- March 11, 2025 (for April 10, 2025 application)
- July 12, 2025 (for August 11, 2025 application)
Application Deadlines:
- April 10, 2025
- August 11, 2025
Expiration Date: August 12, 2025

All applications are due by 5:00 PM local time of the applicant organization.

Funding Amount

Award Size: Up to $5,000,000 per year in direct costs
Project Duration: Up to 3 years
Funding Mechanism: Cooperative Agreement (U01)
Anticipated Number of Awards: Approximately 5 per year (contingent on NIH appropriations and meritorious applications)
Cost Sharing: Not required

Eligibility

Eligible applicants include:

Public and private institutions of higher education (including foreign organizations)
Nonprofits (with or without 501(c)(3) status)
For-profit organizations (including small businesses)
State, county, city, township, and special district governments
Independent school districts
Public housing authorities/Indian housing authorities
Native American tribal governments and organizations (federally recognized and other)
Faith-based and community-based organizations
Regional organizations
U.S. territories and possessions
Non-domestic (non-U.S.) entities and foreign components of U.S. organizations

Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to apply. Multiple applications from the same organization are allowed if scientifically distinct.

Application Process

Submission: Applications must be submitted electronically via Grants.gov, NIH ASSIST, or an institutional system-to-system solution.
Required Registrations: All applicant organizations must have active registrations in SAM, eRA Commons, and Grants.gov. Registration can take 6+ weeks.
Letter of Intent: Strongly encouraged, but not required. Should include project title, PI(s), key personnel, institutions, and FOA number/title. Email to: NIDALetterofIntent@mail.nih.gov
Application Format: Follow the NIH SF424 (R&R) Application Guide and the specific instructions in the funding announcement.
Key Application Requirements:
- Clearly define the entry and exit points in the FDA approval pathway.
- Include a decision tree with go/no-go milestones.
- For clinical trials, describe methods to evaluate medication compliance.
- Data Management and Sharing Plan is required.
- Use of common data elements (e.g., PhenX Toolkit) is encouraged for human studies.
Appendices: Only limited materials allowed (e.g., blank questionnaires).

Additional Information

Scope: Only projects focused on medication development for SUDs are responsive. Projects evaluating psychosocial interventions or focusing solely on alcohol use are not eligible.
NIDA Involvement: NIDA program staff will have substantial involvement in project oversight, including scientific direction, milestone review, and data management.
Milestone-Driven: Annual funding is contingent on progress toward agreed-upon milestones.
Clinical Trials: Both clinical trial and non-clinical trial applications are accepted.
Foreign Applicants: Non-U.S. institutions and foreign components are eligible and encouraged to apply.

External Links

Contact Information

Topic	Contact Name/Email	Phone
General Grants Info	GrantsInfo@nih.gov	301-480-7075
Application Submission (eRA)	eRA Service Desk	301-402-7469 or 866-504-9552
Grants.gov Support	support@grants.gov	800-518-4726
Scientific/Research Contacts	Drew Townsend, Ph.D. drew.townsend@nih.gov Ivan Montoya, M.D., M.P.H. imontoya@mail.nih.gov Evan Herrmann, Ph.D. evan.herrmann@nih.gov	301-443-4577 (Townsend) 301-827-5936 (Montoya) 301-827-6406 (Herrmann)
Peer Review Contact	NIDAPeerReview@nih.gov
Grants Management	Chief Grants Management Officer nidagmbemail@nida.nih.gov