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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.
Funding Opportunity Number: RFA-MH-27-135. Assistance Listing: 93.242,93.279. Funding Instrument: G. Category: HL. Award Amount: $5.5M total program funding.
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Opportunity Listing - Addressing Methodological Challenges with Clinical Trials of Rapid-Acting Psychotropic Interventional Drugs (RAPIDs) (R01 Clinical Trial Required) Addressing Methodological Challenges with Clinical Trials of Rapid-Acting Psychotropic Interventional Drugs (RAPIDs) (R01 Clinical Trial Required) Agency: National Institutes of Health Assistance Listings: 93.
242 -- Mental Health Research Grants Last Updated: February 9, 2026 View version history on Grants. gov The National Institute of Mental Health (NIMH) intends to publish a Notice of Funding Opportunity (NOFO) to solicit applications for research that addresses methodological challenges associated with clinical trials involving rapid-acting psychotropic interventional drugs (RAPIDs).
RAPIDs, including 5-HT2A agonists such as psilocybin, dissociative anesthetics such as ketamine, and entactogens such as 3,4-methylenedioxymethamphetamine (MDMA), have demonstrated promising benefits for the relief of depression, anxiety and other mental health disorders.
The goal of this NOFO is to improve the understanding of the key components underlying the therapeutic effects of RAPIDs and thereby increase confidence in the results from clinical trials with RAPID intervention(s). Applications are not being solicited at this time. Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.
This NOFO will utilize the R01 activity code. Investigators with expertise and insights into the therapeutic effects of RAPIDs are encouraged to consider applying for this new NOFO. In addition, collaborative research that integrates expertise in RAPID research and innovative trial design are encouraged.
Applicants are encouraged to interact with the U.S. Food and Drug Administration (FDA) prior to application submission to ensure the proposed study will satisfy regulatory requirements.
For-profit organizations other than small businesses Public and state institutions of higher education Private institutions of higher education Independent school districts Federally recognized Native American tribal governments Public and Indian housing authorities Other Native American tribal organizations Nonprofits non-higher education with 501(c)(3) Grantor contact information Division of Translational Research Please contact via e-mail DTRcommunications@nih.
gov DTRcommunications@nih. gov No documents are currently available. Link to additional information Estimated Application Due Date : Estimated Due Date Description : Estimated Project Start Date : Funding opportunity number : Cost sharing or matching requirement : Funding instrument type : Opportunity Category Explanation : Category of Funding Activity :
According to the current listing, eligibility includes: Eligible applicants: 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); 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 (see text field entitled Additional Information on Eligibility for clarification). 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. Confirm the full requirements in the official notice before applying.
The current listing shows $5.5M total program funding. Verify award ceilings, matching requirements, and allowable costs in the official notice.
Applications for Addressing Methodological Challenges with Clinical Trials of Rapid-Acting Psychotropic Interventional Drugs (RAPIDs) (R01 Clinical Trial Required) are due October 11, 2026. Build your timeline backwards from this date to cover registrations, approvals, and final submission checks.
Yes — Addressing Methodological Challenges with Clinical Trials of Rapid-Acting Psychotropic Interventional Drugs (RAPIDs) (R01 Clinical Trial Required) is offered by National Institutes of Health and this listing comes from Grants.gov, an official U.S. federal source. Federal applications generally require registrations (for example SAM.gov or an agency submission portal), so allow extra lead time.
Start from the official opportunity page linked in this listing — it carries the sponsor's submission instructions.
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