Addressing Methodological Challenges with Clinical Trials of Psychotomimetic Agents

The National Institute of Mental Health (NIMH), a key agency under the Department of Health and Human Services (HHS), intends to release a Notice of Funding Opportunity (NOFO) titled "Addressing Methodological Challenges with Clinical Trials of Psychotomimetic Agents." This opportunity is designed to advance research methodologies related to clinical trials involving psychotomimetic agents (PMAs), such as classic psychedelics (psilocybin), dissociative anesthetics (ketamine), and entactogens (MDMA). The research is rooted in the promising potential of these agents to treat a range of mental health disorders, including depression and anxiety, and aims to deepen scientific understanding of the mechanisms underlying their therapeutic effects. This funding opportunity is classified as a discretionary grant and falls under the Health funding activity category. The anticipated NOFO will use the R01 grant mechanism and is forecasted to make available a total of $5,000,000 in funding, with an estimated five awards. However, the award ceiling and floor have not yet been disclosed and must be confirmed upon official NOFO publication. The aim is to enhance methodological rigor in clinical trials of PMAs, thus ensuring confidence in their results and reproducibility. Emphasis is placed on integrating innovative trial designs with expertise in psychedelic research. Eligibility for this opportunity is broad. Eligible applicants include a range of entities such as state and county governments, Native American tribal governments (both federally and non-federally recognized), public and private institutions of higher education, public housing authorities, independent school districts, 501(c)(3) nonprofit organizations (excluding institutions of higher education), small businesses, and other for-profit organizations. This wide scope supports a multidisciplinary research environment conducive to collaboration across public, private, and academic sectors. As this is a forecasted opportunity, applications are not yet being accepted. The estimated posting date is September 3, 2025, with applications expected to be due by November 3, 2025. The estimated award notification date is July 1, 2026, and successful projects are anticipated to start on that same day. Interested applicants are encouraged to use the forecast window to build collaborative relationships and design responsive research proposals. In addition, applicants should consult with the U.S. Food and Drug Administration (FDA) before submitting applications to ensure compliance with regulatory standards for clinical research involving PMAs. The NOFO encourages collaborative research integrating diverse expertise, particularly in areas of clinical trial design and psychedelic research. Investigators with experience in PMAs are strongly encouraged to apply. The initiative explicitly aims to improve methodological standards and address challenges unique to researching psychotomimetic agents within controlled clinical settings. For more information, potential applicants may contact Dr. Jonathan Sabbagh at the National Institute of Mental Health by phone at 301-793-3534 or via email at jonathan.sabbagh@nih.gov. Updates and additional information will be made available on Grants.gov as the NOFO progresses to its official posting.