Opportunity Information: Apply for RFA MH 27 135
The National Institutes of Health (NIH) is offering an R01 grant funding opportunity titled "Addressing Methodological Challenges with Clinical Trials of Rapid-Acting Psychotropic Interventional Drugs (RAPIDs) (R01 Clinical Trial Required)" under Funding Opportunity Number RFA-MH-27-135. The central goal is to improve how clinical trials are designed and conducted for rapid-acting psychotropic interventional drugs, with an emphasis on solving practical and scientific trial-method problems that make it hard to interpret results or apply them broadly in real-world care. This program is focused on generating clearer, more reliable evidence about what exactly drives the therapeutic effects of RAPIDs, and how best to deliver these interventions over time so benefits are not just rapid, but also meaningful, durable, and generalizable.
A major theme is methodology. The NOFO is looking for studies that directly tackle the design and implementation challenges that tend to show up in trials of fast-acting psychiatric interventions. Because RAPIDs can produce noticeable effects quickly, trials can be vulnerable to issues like expectancy effects, functional unblinding, measurement timing problems, and difficulty separating drug effects from the influence of clinical contact or supportive care. In that context, this opportunity supports work that strengthens rigor, improves interpretability, and ultimately makes trial outcomes easier to trust and compare across sites and studies. The intent is not simply to run another efficacy trial, but to build better trial approaches that clarify mechanisms and improve the quality of evidence produced in this area.
Another key emphasis is how RAPIDs interact with adjunctive psychosocial interventions. The NOFO specifically calls for advancing understanding of how drug interventions and psychosocial supports can be delivered, monitored, and sustained over time to maximize effectiveness. That includes practical questions about implementation in clinical settings, how to standardize or optimize supportive therapies that may accompany drug administration, and how to track outcomes and safety over longer periods so that results reflect what patients and clinicians actually need. The expectation is that funded projects will help define best practices around combining pharmacologic and psychosocial components, and will produce findings that translate beyond tightly controlled research settings.
The funding mechanism is an NIH R01, and the announcement explicitly requires a clinical trial. That means applicants should be planning a study that prospectively assigns human participants to one or more interventions to evaluate the effects on health-related biomedical or behavioral outcomes, consistent with NIH's clinical trial definition. The NOFO anticipates making around five awards. While an award ceiling is not listed in the provided summary, applicants would generally be expected to propose budgets appropriate to the scope of an R01 and consistent with NIH policy and the specific NOFO instructions.
In terms of who can apply, eligibility is broad within the United States and includes state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; other Native American tribal organizations; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; and small businesses. At the same time, the opportunity is clear about international limitations: non-U.S. entities are not eligible to apply, non-U.S. components of U.S. organizations are not eligible, and foreign components (as NIH defines them) are not allowed. In practice, that means the work and funded activities need to be U.S.-based without foreign subawards or foreign performance sites.
Key dates in the provided listing include a creation date of April 29, 2026, and an original closing date of October 11, 2026. The program sits within NIH's health-related research portfolio and is associated with CFDA numbers 93.242 and 93.279. Overall, this NOFO is best read as a targeted push to raise the scientific quality and real-world usefulness of RAPID clinical trials by improving trial methods, clarifying what contributes to observed benefits, and developing evidence-informed ways to pair these interventions with psychosocial supports for better and more sustainable patient outcomes.Apply for RFA MH 27 135
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Addressing Methodological Challenges with Clinical Trials of Rapid-Acting Psychotropic Interventional Drugs (RAPIDs) (R01 Clinical Trial Required)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.242, 93.279.
- This funding opportunity was created on 2026-04-29.
- Applicants must submit their applications by 2026-10-11. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The number of recipients for this funding is limited to 5 candidate(s).
- Eligible applicants include: 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.
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Frequently Asked Questions (FAQs)
What is the name of this NIH funding opportunity?
The funding opportunity is titled "Addressing Methodological Challenges with Clinical Trials of Rapid-Acting Psychotropic Interventional Drugs (RAPIDs) (R01 Clinical Trial Required)."
What is the Funding Opportunity Number (NOFO number)?
The Funding Opportunity Number is RFA-MH-27-135.
What type of grant mechanism is being used?
This opportunity uses the NIH R01 research project grant mechanism.
Is a clinical trial required under this opportunity?
Yes. The announcement explicitly requires a clinical trial, meaning the proposed study should prospectively assign human participants to one or more interventions to evaluate effects on health-related biomedical or behavioral outcomes, consistent with NIH's clinical trial definition.
What is the overall goal of the NOFO?
The central goal is to improve how clinical trials are designed and conducted for rapid-acting psychotropic interventional drugs (RAPIDs), particularly by addressing practical and scientific trial-method problems that can make results difficult to interpret or apply in real-world care.
What is the main scientific theme of the program?
A major theme is methodology: strengthening rigor, improving interpretability, and making trial outcomes easier to trust and compare across sites and studies in the RAPIDs space.
Is this intended to fund standard efficacy trials of RAPIDs?
No. The intent is not simply to run another efficacy trial, but to build and test better trial approaches that clarify mechanisms and improve the quality of evidence produced for rapid-acting psychiatric interventions.
What kinds of trial-method problems does the NOFO highlight for RAPIDs?
The provided summary emphasizes issues that can be especially challenging when effects occur quickly, including expectancy effects, functional unblinding, measurement timing problems, and difficulty separating drug effects from the influence of clinical contact or supportive care.
Why are expectancy effects and functional unblinding especially important in RAPIDs trials?
Because RAPIDs can produce noticeable effects rapidly, participants and staff may infer treatment assignment more easily, which can influence reported outcomes and complicate interpretation.
What does the NOFO mean by improving "interpretability" and "generalizability"?
In this context, it means producing clearer, more reliable evidence about what drives therapeutic effects and ensuring results can be applied more broadly to real-world clinical care, not only to tightly controlled research settings.
Does the NOFO emphasize understanding mechanisms of action?
Yes. The program is focused on generating clearer evidence about what exactly drives the therapeutic effects of RAPIDs.
Does the NOFO address how to sustain benefits over time?
Yes. It emphasizes determining how best to deliver these interventions over time so benefits are not only rapid, but also meaningful, durable, and generalizable.
How does the NOFO treat the role of psychosocial interventions?
A key emphasis is how RAPIDs interact with adjunctive psychosocial interventions, including how drug interventions and psychosocial supports can be delivered, monitored, and sustained over time to maximize effectiveness.
What kinds of practical psychosocial questions are included in scope?
The summary points to practical questions such as implementation in clinical settings, how to standardize or optimize supportive therapies that may accompany drug administration, and how to track outcomes and safety over longer periods.
Is the program interested in real-world relevance of trial designs?
Yes. The summary indicates an expectation that findings will translate beyond tightly controlled research settings and reflect what patients and clinicians actually need.
How many awards does NIH anticipate making?
The NOFO anticipates making around five awards.
Is there a stated budget cap or award ceiling in the provided information?
No award ceiling is listed in the provided summary. The summary notes that applicants would generally be expected to propose budgets appropriate to the scope of an R01 and consistent with NIH policy and the specific NOFO instructions.
Who is eligible to apply?
Eligibility is broad within the United States and includes state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; other Native American tribal organizations; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; and small businesses.
Are non-U.S. entities eligible to apply?
No. Non-U.S. entities are not eligible to apply.
Can a U.S. organization include a non-U.S. component in the project?
No. The opportunity states that non-U.S. components of U.S. organizations are not eligible.
Are foreign components allowed (as NIH defines them)?
No. Foreign components are not allowed under this opportunity.
What do the international limitations imply for where the work must be performed?
Based on the summary, the funded activities need to be U.S.-based, without foreign subawards or foreign performance sites.
What are the key dates listed in the provided information?
The listing includes a creation date of April 29, 2026, and an original closing date of October 11, 2026.
What agency is offering this opportunity?
The opportunity is offered by the National Institutes of Health (NIH).
What CFDA numbers are associated with this opportunity?
The summary associates this NOFO with CFDA numbers 93.242 and 93.279.
What is the intended impact of funding under this NOFO?
The intended impact is to raise the scientific quality and real-world usefulness of RAPIDs clinical trials by improving trial methods, clarifying what contributes to observed benefits, and developing evidence-informed ways to pair these interventions with psychosocial supports for better and more sustainable patient outcomes.
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