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

Safety and Early Efficacy Studies of Psychedelic-Assisted Therapy for Chronic Pain in Older Adults (UG3/UH3 Clinical Trial Required) is sponsored by National Institute on Aging (NIA). This opportunity supports mission-aligned projects and measurable outcomes.

A **. gov** website belongs to an official government organization in the United States.

* How to Apply for Grants * **Applicant Resources** * Adobe Software Compatibility * Submitting UTF-8 Special Characters * Encountering Error Messages * Grantor Standard Language * Submitting UTF-8 Special Characters * **Applicant System-To-System** * Reference Implementation * **Grantor System-To-System** * Reference Implementation * SF-424 Individual Family * SF-424 Mandatory Family * SF-424 Short Organization Family * Post-Award Reporting Forms * Country and State Lists Updates * **Manage Subscriptions** * Program Management Office * Grants.

gov Maintenance Calendar Safety and Early Efficacy Studies of Psychedelic-Assisted Therapy for Chronic Pain in Older Adults (UG3/UH3 Clinical Trial Required) Department of Health and Human Services National Institutes of Health Document Type:Grants Notice Funding Opportunity Number:RFA-AG-25-004 Funding Opportunity Title:Safety and Early Efficacy Studies of Psychedelic-Assisted Therapy for Chronic Pain in Older Adults (UG3/UH3 Clinical Trial Required) Opportunity Category:Discretionary Opportunity Category Explanation: Funding Instrument Type:Cooperative Agreement Category of Funding Activity:Health Expected Number of Awards: Assistance Listings:93.

213 -- Research and Training in Complementary and Integrative Health Cost Sharing or Matching Requirement:No Last Updated Date:Apr 24, 2024 Original Closing Date for Applications:Oct 10, 2024 Current Closing Date for Applications:Oct 10, 2024 Archive Date:Nov 15, 2024 Estimated Total Program Funding: Eligible Applicants:Native American tribal governments (Federally recognized) Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education Special district governments City or township governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled institutions of higher education For profit organizations other than small businesses Public housing authorities/Indian housing authorities Independent school districts Others (see text field entitled "Additional Information on Eligibility" for clarification) Additional Information on Eligibility: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.

## Additional Information Agency Name:National Institutes of Health Description: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. Link to Additional Information:https://grants. nih.

gov/grants/guide/rfa-files/RFA-AG-25-004. html Grantor Contact Information:If you have difficulty accessing the full announcement electronically, please contact: See Section VII. Agency Contacts within the full opportunity announcement for all other inquires.

#### Health & Human Services * Frequently Asked Questions ## Your session will expire in 3 minutes. To continue working, click on the "OK" button below. This is being done to protect your privacy.

Unsaved changes will be lost.