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.