RFA-AG-25-004: Safety and Early Efficacy Studies of Psychedelic-Assisted Therapy for Chronic Pain in Older Adults (UG3/UH3 Clinical Trial Required)
Closed
This grant is closed. Who won this program's grants before is below, and similar open grants are at the end of the page. It is in our archive of National Institutes of Health notices from 2024.
National Institutes of Health offered grants to nonprofits, colleges and universities, state and local governments, tribes, small businesses and businesses. Applications closed on October 10, 2024.
From the official notice on Grants.gov, last changed April 24, 2024. Checked November 7, 2026.
- Award amountsNot given on Grants.gov
- Cost sharingNot required
- Funding typeCooperative Agreement
About this NIH notice
- Activity codeUG3 / UH3
- Clinical trialsRequired
- Funded byNIA
- Median yearly award$3.3 million
- Typical project length2 years
- UG3, Exploratory/Developmental Phase I Cooperative Agreement. The first phase of a phased cooperative agreement. Moving on to the UH3 phase depends on meeting agreed milestones. Other open UG3 notices.
- UH3, Exploratory/Developmental Cooperative Agreement Phase II. The second phase of a phased cooperative agreement, usually following a UG3 or UH2 phase. Other open UH3 notices.
Projects funded under RFA-AG-25-004 were run by National Institute on Aging (NIA, 1 project). Contact the program officer at the institute that fits your project before you apply; the notice lists them.
Application due dates, page limits and budget limits are set in the notice. Read RFA-AG-25-004 in the NIH Guide.
Key dates
| Posted | April 24, 2024 |
|---|---|
| Deadline | October 10, 2024 |
| Archived by Grants.gov | November 15, 2024 |
Who can apply
This opportunity was open to nonprofits, colleges and universities, state and local governments, tribes, small businesses and businesses.
All 15 applicant types the notice lists
- State governments
- County governments
- City or township governments
- Special district governments
- Independent school districts
- Public and State controlled institutions of higher education
- Native American tribal governments (Federally recognized)
- Public housing authorities/Indian housing authorities
- Native American tribal organizations (other than Federally recognized tribal governments)
- Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
- Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
- Private institutions of higher education
- For profit organizations other than small businesses
- Small businesses
- Others (see text field entitled "Additional Information on Eligibility" for clarification)
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; Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Is this a realistic fit?
- Most of the money in the 2 programs behind this notice (73% over five years) went to colleges and universities.
- No cost sharing or match is required.
What the grant funds
The purpose of this funding opportunity is to support a multi-center consortium that will function as a clinical trials network to collect safety and early efficacy data in defined groups of older adults with specific chronic pain conditions. This funding opportunity will use a UG3/UH3 phased innovation mechanism, and responsive applications must include a research plan describing both UG3 and UH3 phases. UG3 (1st phase) studies, lasting up to 2 years, should involve preliminary studies in healthy older adults across a broad age range to evaluate safety, pharmacokinetic, and pharmacodynamic properties of psychedelic agents and preliminary testing of study elements that will inform further development and testing in the UH3 (2nd) phase. UH3 studies, lasting up to 3 years, should include expanded safety and preliminary efficacy studies in older adults with chronic pain conditions and include participants with non-contraindicated co-occurring conditions representative of real-world older adults. In both phases of the award, participants across a broad range of ages should be included, with particular attention to strata at the upper age range (i.e., 75-80 years, and 80+ years old). For the purposes of this RFA, the term psychedelic includes classic psychedelics, typically understood to be 5-HT2 agonists such as psilocybin,N,N-Dimethyltryptamine(DMT), lysergic acid diethylamide (LSD), and mescaline, as well as entactogens or empathogens such as methylenedioxymethamphetamine (MDMA). Synthetic analogs of these agents are also included. Cannabis, ketamine, and their related products are not considered psychedelic agents in this RFA.
Funded under RFA-AG-25-004 so far
NIH funded 1 project under RFA-AG-25-004 in fiscal 2025 to 2026, at 1 institution. The median yearly award was $3.3 million.
| Project | Institution | Fiscal year | Award |
|---|---|---|---|
| Psychedelics for Older Adults with Chronic Pain | University of Colorado Denver | 2026 | $3.1 million |
Who has won Aging Research grants before
From fiscal 2021 to 2025, Aging Research (93.866) awarded $19 billion across 11,026 grant awards, an average of $1.7 million per award.
| Recipient | State | Awards | Amount |
|---|---|---|---|
| The Regents of the University of California, San Francisco | California | 337 | $575 million |
| The Trustees of Columbia University in the City of New York | New York | 242 | $574 million |
| University of Southern California | California | 203 | $572 million |
| The Washington University | Missouri | 210 | $556 million |
| Regents of the University of Michigan | Michigan | 232 | $538 million |
Who has won Research and Training in Complementary and Integrative Health grants before
From fiscal 2021 to 2025, Research and Training in Complementary and Integrative Health (93.213) awarded $575 million across 653 grant awards, an average of $880,790 per award.
| Recipient | State | Awards | Amount |
|---|---|---|---|
| Yale Univ | Connecticut | 15 | $25.9 million |
| The General Hospital Corporation | Massachusetts | 23 | $23.1 million |
| Duke University | North Carolina | 11 | $20.0 million |
| The Regents of the University of California, San Francisco | California | 16 | $15.2 million |
| Regents of the University of Minnesota | Minnesota | 13 | $15.0 million |
Applying now
This notice no longer takes applications. Agencies often post the same opportunity again under a new number, so check the program's notices on Grants.gov and the similar open grants below.
The notice on Grants.gov keeps its full text and attachments, which is useful for planning a resubmission.
Questions people ask
Is RFA-AG-25-004 still open?
No. It closed on October 10, 2024.
Who can apply for Safety and Early Efficacy Studies of Psychedelic-Assisted Therapy for Chronic Pain in Older Adults (UG3/UH3 Clinical Trial Required)?
National Institutes of Health accepted applications from nonprofits, colleges and universities, state and local governments, tribes, small businesses and businesses. The notice adds further conditions, so read its eligibility section.
What is the deadline for Safety and Early Efficacy Studies of Psychedelic-Assisted Therapy for Chronic Pain in Older Adults (UG3/UH3 Clinical Trial Required)?
Closed October 10, 2024. Applications are no longer accepted; the program's newer notices are on this page when there are any.
Who has been funded under RFA-AG-25-004?
NIH RePORTER lists 1 project funded under RFA-AG-25-004 in fiscal 2025 to 2026, at 1 institution.
Who has won Research and Training in Complementary and Integrative Health grants before?
The largest recipients over five fiscal years were Yale Univ, The General Hospital Corporation, Duke University. The program made 653 awards worth $575 million in that time.
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