# Safety and Early Efficacy Studies of Psychedelic-Assisted Therapy for Chronic Pain in Older Adults (UG3/UH3 Clinical Trial Required)

Source: https://welltoldgrants.com/grants/rfa-ag-25-004-safety-and-early-efficacy-studies-of-psychedelic-assisted/  
Official notice: https://www.grants.gov/search-results-detail/353760

> 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.

| Field | Value |
|---|---|
| Opportunity number | RFA-AG-25-004 |
| Agency | National Institutes of Health |
| Status | Forecast |
| Deadline | October 10, 2024 |
| Award ceiling | not stated |
| Award floor | not stated |
| Expected awards | not stated |
| Total funding | not stated |
| Cost sharing | not required |
| Assistance Listings | 93.213, 93.866 |

## Who can apply

- 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.

## 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.

## 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.