This Federal Health Department grant aims to establish a multi-center clinical trials network to evaluate the safety and early efficacy of psychedelic-assisted therapy for chronic pain in older adults. This grant is for supporting a phased research approach. The initial UG3 phase (up to 2 years) will focus on preliminary studies in healthy older adults, assessing safety, pharmacokinetic, and pharmacodynamic properties of various classic psychedelics (e.g., psilocybin, LSD, MDMA). The subsequent UH3 phase (up to 3 years) will expand into preliminary efficacy and safety studies in older adults experiencing chronic pain, including those with co-occurring conditions, ensuring a broad age representation, especially individuals 75 years and older. Cannabis and ketamine are excluded from this definition of psychedelic agents.
Opportunity ID: 353760
General Information
| 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 |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.213 — Research and Training in Complementary and Integrative Health |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Apr 24, 2024 |
| 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: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal governments (Federally recognized) State governments Small businesses Private institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Special district governments Public and State controlled institutions of higher education Public housing authorities/Indian housing authorities Independent school districts City or township governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) County governments For profit organizations other than small businesses |
| 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:
NIH Grants Information
grantsinfo@nih.gov Email:grantsinfo@nih.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
Folder 353760 Full Announcement-RFA-AG-25-004 -> RFA-AG-25-004-Full-Announcement.pdf
Packages
| Agency Contact Information: | NIH Grants Information grantsinfo@nih.gov Email: grantsinfo@nih.gov |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| FORMS-H | Use for due dates on or after January 25, 2023 | PKG00286051 | Sep 10, 2024 | Oct 10, 2024 | View |
Package 1
Mandatory forms
353760 RR_SF424_5_0-5.0.pdf
353760 PHS398_CoverPageSupplement_5_0-5.0.pdf
353760 RR_OtherProjectInfo_1_4-1.4.pdf
353760 PerformanceSite_4_0-4.0.pdf
353760 RR_KeyPersonExpanded_4_0-4.0.pdf
353760 RR_Budget10_3_0-3.0.pdf
353760 PHS398_ResearchPlan_5_0-5.0.pdf
353760 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
353760 RR_SubawardBudget10_30_3_0-3.0.pdf
353760 PHS_AssignmentRequestForm_3_0-3.0.pdf
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