Addressing Methodological Challenges with Clinical Trials of Rapid-Acting Psychotropic Interventional Drugs (RAPIDs) (R01 Clinical Trial Required)
Closed Posted
- Opportunity number
- RFA-MH-27-135
- Agency
-
National Institutes of Health
Department of Health and Human Services
- Applications due
- Award size
- Not on record
Opportunity facts
- Assistance listings
- Funding instrument
- Grant
- Category
-
- Health
- Eligible applicants
-
- State Governments
- City/Township Governments
- Small Businesses
- Tribal Governments (Federally Recognized)
- Other
- Higher Education Inst. (Private)
- Public or Indian Housing Auth.
- For Profit Organizations
- Higher Education Inst. (Public)
- Independent School Districts
- Special District Governments
- County Governments
- Non-501(c)(3) Nonprofits
- 501(c)(3) Nonprofits
- Tribal Organizations (Not Federally Recognized)
- Points of contact
Opportunity details come from Grants.gov. Updated .
About this opportunity
The National Institute of Mental Health (NIMH) is soliciting applications for research addressing methodological challenges in clinical trials of rapid-acting psychotropic interventional drugs (RAPIDs), with applications due by October 11, 2026. This is an R01 Clinical Trial Required mechanism. NIMH intends to commit up to $5,000,000 in FY 2027 to fund up to 5 awards; the National Institute on Drug Abuse (NIDA) will commit an additional $500,000 for one award. No cost sharing is required.
Eligible applicants include higher education institutions (public and private), nonprofits (501(c)(3) and non-501(c)(3)), for-profit organizations, state and local governments, tribal organizations (federally and non-federally recognized), and faith-based entities. Non-U.S. entities and foreign components are ineligible.
The maximum project period is 5 years. Research must address methodological challenges specific to RAPID clinical trials, including expectancy effects, blind integrity for participants and therapists, appropriate control comparators, selection bias, and standardization of adjunctive psychotherapy. RAPIDs include 5-HT2A agonists such as psilocybin, dissociative anesthetics such as ketamine, and entactogens such as MDMA. Studies must evaluate a neurobiological readout of RAPID response in a dose-dependent manner, assess and monitor expectancy effects and blind integrity, and document FDA regulatory oversight status (IND approval required prior to award). All applications must include a detailed Data Management and Sharing Plan with submission to the National Institute of Mental Health Data Archive and comprehensive human subjects protections documentation. Program directors and principal investigators must have eRA Commons accounts and ORCID registration.
Applications are not currently being solicited; this notice provides advance opportunity for applicants to develop collaborations. Applicants are encouraged to interact with the FDA prior to submission. Assistance Listing 93.242 (Mental Health Research Grants) and 93.279 (Drug Use and Addiction Research Programs).
Synopsis
The purpose of this notice of funding opportunity (NOFO) is to elucidate the key components of the therapeutic effects of rapid-acting psychotropic interventional drugs (RAPIDs) by addressing the methodological challenges involved with these clinical trials. In addition, this NOFO seeks to advance understanding of how RAPIDs and adjunctive psychosocial interventions can be optimally delivered, monitored, and sustained over time to enhance effectiveness and generalizability. The NOFO will support studies designed to enhance the rigor of RAPID clinical trial design, which will ultimately increase the interpretability of the data and the generalizability of the results.
Eligibility
Refer to Section III. Eligibility Information in the NOFO for additional information on eligibility.Foreign Organizations/International CollaborationsNon-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 not allowed.
Files
| File | Type | Posted |
|---|---|---|
| RFA-MH-27-135-Revised-Full-Announcement.html | HTML file | |
| PKG00292529.pdf |
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