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Addressing Methodological Challenges with Clinical Trials of Rapid-Acting Psychotropic Interventional Drugs (RAPIDs) (R01 Clinical Trial Required)

ID: RFA-MH-27-135 • Type: Posted
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Description

Posted: April 29, 2026, 12:00 a.m. EDT
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.
Posted: April 29, 2026, 12:00 a.m. EDT
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Posted: June 17, 2025, 12:00 a.m. EDT
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Posted: June 17, 2025, 12:00 a.m. EDT
Background
The National Institutes of Health (NIH), specifically the National Institute of Mental Health (NIMH) and the National Institute on Drug Abuse (NIDA), is issuing this Notice of Funding Opportunity (NOFO) to address the methodological challenges associated with clinical trials of rapid-acting psychotropic interventional drugs (RAPIDs).

The goal is to enhance understanding of the therapeutic effects of RAPIDs and adjunctive psychosocial interventions, ensuring they are optimally delivered, monitored, and sustained over time. This initiative aims to increase the rigor of RAPID clinical trial design, thereby improving data interpretability and result generalizability.

Grant Details
This NOFO supports research aimed at addressing methodological challenges in clinical trials involving RAPIDs. Key tasks include:
1. Maximizing blind integrity and minimizing expectancy bias in trials.
2. Exploring optimal control comparison conditions for trials.
3. Identifying objective biological measures associated with treatment response.
4. Evaluating neurobiological substrates linked to treatment response as objective measures of RAPID efficacy.
5. Justifying and evaluating intervention delivery parameters including RAPID dosing schedules and adjunctive psychosocial intervention structures.
6. Providing a complete description of any combined psychotherapy protocols, including type, number of sessions, and protocol details.
7. Developing biological readouts that allow for causal inference regarding treatment effects.

Eligibility Requirements
Eligible applicants include higher education institutions, nonprofits, for-profit organizations, local governments, state governments, tribal governments, and other entities as specified in the eligibility section. Non-domestic entities are not eligible to apply.

Period of Performance
The maximum project period is 5 years, with funding anticipated for FY 2027.

Grant Value
NIMH intends to commit up to $5 million in FY 2027 to fund up to 5 awards; NIDA intends to commit $500,000 for one award.
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Overview

Agency
National Institutes of Health (NIH) [HHS]
Category of Funding
Health
Funding Instruments
Grant
Grant Program (CFDA)
93.242 - Mental Health Research Grants
93.279 - Drug Abuse and Addiction Research Programs
Grant Category
Discretionary
Cost Sharing / Matching Requirement
False
Source
Grants.gov
On 4/29/26 the National Institutes of Health posted grant opportunity RFA-MH-27-135 for Addressing Methodological Challenges with Clinical Trials of Rapid-Acting Psychotropic Interventional Drugs (RAPIDs) (R01 Clinical Trial Required) with funding of $5.5 million. The grant will be issued under grant program 93.242 Mental Health Research Grants. It is expected that 5 total grants will be made.

Timing

Posted Date
April 29, 2026, 12:00 a.m. EDT
Closing Date
Oct. 11, 2026, 12:00 a.m. EDT Due in 139 Days
Last Updated
April 29, 2026, 1:35 p.m. EDT
Version
2
Archive Date
Dec. 10, 2026

Eligibility

Eligible Applicants
Public housing authorities/Indian housing authorities
Native American tribal governments (Federally recognized)
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Special district governments
Small businesses
City or township governments
Independent school districts
County governments
Others (see text field entitled "Additional Information on Eligibility" for clarification)
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Public and State controlled institutions of higher education
State governments
For profit organizations other than small businesses
Private institutions of higher education
Native American tribal organizations (other than Federally recognized tribal governments)
Additional Info
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.

Award Sizing

Ceiling
Not Listed
Floor
Not Listed
Estimated Program Funding
$5,500,000
Estimated Number of Grants
5

Contacts

Contact
National Institutes of Health
Contact Email
dtrcommunications@nih.gov
Contact Phone
(301) 402-2541

Documents

Posted documents for RFA-MH-27-135

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