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Addressing Methodological Challenges with Clinical Trials of Psychotomimetic Agents
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Service Source Final Application Due Date Funding Available Match Required
Health Care Federal
HHS
11-03-2025 $5.0 M No Match
Required
  • Service
  • Source
  • Final Application Due Date
  • Funding Available
  • Match Required
Status
  • Past
  • Current
  • Forecasted
    • Expected Number of Awards 5
    • Opportunity Type Discretionary
    • CFDA

      93.242 -- Mental Health Research Grants

    Description

    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 psychotomimetic agents (PMAs). PMAs, including classic psychedelics 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 PMAs and thereby increase confidence in the results from clinical trials with PMA 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 PMAs are encouraged to consider applying for this new NOFO. In addition, collaborative research that integrates expertise in psychedelic 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.

    Eligibility
    • IHE
    • Local Government
    • Non-Profit
    • Other
    • State Government
    • Tribal Government
    Key Date(s)
    • June 17, 2025: Last Updated Date
    • June 17, 2025: Forecasted Date
    • September 03, 2025: Estimated Post Date
    • November 03, 2025: Estimated Application Due Date
    • July 01, 2026: Estimated Project Start Date
    • July 01, 2026: Estimated Award Date
    Contact Information
    Jonathan Sabbagh, Ph.D. National Institute of Mental Health, NIMH 301-793-3534 jonathan.sabbagh@nih.gov

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