Addressing Methodological Challenges with Clinical Trials of Psychotomimetic Agents

Key Facts

Status: Open

Posted date: June 17, 2025

Opportunity ID: 359202

Opportunity number: FOR-MH-26-185

Opportunity category: Discretionary

Agency name: National Institutes of Health

Agency code: HHS-NIH11

Award floor: $0

Award ceiling: $0

Cost sharing required: No

Funding Instrument Types
  • Grant
Category of Funding Activity
  • Health
Eligible Applicants
  • County governments
  • For-profit organizations other than small businesses
  • Independent school districts
  • Native American tribal governments (Federally recognized)
  • 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
  • Private institutions of higher education
  • Public and State controlled institutions of higher education
  • Public housing authorities/Indian housing authorities
  • Small businesses
  • State governments
Tools
Categories (use these for quoted searches)
  • agency_code:hhs_nih11
  • category_of_funding_activity:health
  • cost_sharing_or_matching_requirement:false
  • eligible_applicants:county_governments
  • eligible_applicants:for_profit_organizations_other_than_small_businesses
  • eligible_applicants:independent_school_districts
  • eligible_applicants:native_american_tribal_governments_federally_recognized
  • eligible_applicants:native_american_tribal_organizations_other_than_federally_recognized_tribal_governments
  • eligible_applicants:nonprofits_having_a_501_c_3_status_with_the_irs_other_than_institutions_of_higher_education
  • eligible_applicants:private_institutions_of_higher_education
  • eligible_applicants:public_and_state_controlled_institutions_of_higher_education
  • eligible_applicants:public_housing_authoritiesindian_housing_authorities
  • eligible_applicants:small_businesses
  • eligible_applicants:state_governments
  • funding_instrument_type:grant
  • opportunity_category:discretionary
  • status:open
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.

Addressing Methodological Challenges with Clinical Trials of Psychotomimetic Agents
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.
Addressing Methodological Challenges with Clinical Trials of Psychotomimetic Agents
Open
National Institutes of Health
Health
Grant
State governments
County 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
Private institutions of higher education
For-profit organizations other than small businesses
Small businesses
2025-06-17