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Advancing Psychedelics Research for Treating Addiction (R61/R33 Clinical Trial Required)
The purpose of this Notice of Funding Opportunity (NOFO) is to encourage clinical research that will advance understanding of how substance use disorder (SUD) relevant cognitive, emotional, and social processes are modulated by Psychedelics. Applications are expected to be exploratory and developmental in nature. As such, these studies may involve considerable risk of failure but may lead to a breakthrough in a particular area that could have a major impact on SUD research involving psychedelics.
This NOFO uses a R61/R33 Phased Innovation award activity code to support applications that propose mechanistic studies designed to understand a behavior or biological process, the pathophysiology of a disease, or the mechanism of action of an intervention. In addition, applications must meet the NIH definition of a clinical trial. NIH defines a clinical trial as “A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.” (NOT-OD-15-015)
Note: For basic science experimental studies involving humans, referred to in NOT-OD-18-212 as “prospective basic science studies involving human participants” please use the companion NOFO - Advancing Psychedelics Research for Treating Addiction (R61/R33 Basic Experimental Studies with Humans (BESH) RFA-DA-24-029.
For projects not requiring a phased research approach, applicants are encouraged to apply under a different activity code (e.g., PA-20-183 Research Project Grant (Parent R01 Clinical Trial Required).
This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP), which will be assessed as part of the scientific and technical peer review evaluation. Applications that fail to include a PEDP will be considered incomplete and will be withdrawn.
Applicants are strongly encouraged to read the NOFO instructions carefully and view the available PEDP guidance material.
Letter of Intent Due Date(s): October 2, 2023
Application Due Date: November 02, 2023
RFA-DA-24-024 Expiration Date November 03, 2023
For the R61 planning phase, the combined budget for direct costs for up to two years may not exceed $700,000. For the R33 phase, budgets may not exceed $500,000 per year and need to reflect the actual needs of the proposed project.