Psychedelics Treatment Research in Substance Use Disorder (UG3/UH3 Clinical Trials Optional)

Background
Psychedelic treatments are currently in clinical development for a range of mental disorders. Therapeutic areas undergoing active clinical research include alcohol and substance use disorders (ASUD). The exploration of the beneficial clinical and functional outcomes require our urgent attention to the refinement and optimization of the psychedelic treatment administration paradigms, and an exploration of novel clinical trial designs, which are of high nascent interest for the ASUD field in general.

Grant Details
The purpose of this notice of funding opportunity (NOFO) is to support the development of classic psychedelics (e.g., psilocybin, LSD), empathogens (e.g., MDMA), dissociatives (e.g., ketamine and related compounds), and other hallucinogens (e.g., ibogaine and its analogues) as new treatment options for Substance Use Disorder (SUD). Applications may include the evaluation of an existing psychedelic, a new formulation, or a new psychedelic compound. The application can be at a preclinical and/or clinical phase of medication development. This NOFO utilizes the UG3/UH3 Phased Innovation Awards Cooperative Agreement grant mechanism that includes two phases. The applications responding to this funding opportunity should present a research plan that will cover both the UG3 and UH3 phases.

In the 2-year UG3 phase, the project will have a set of milestones to be completed by the end of this period. Once the UG3 phase has been successfully completed, the project may transition to the UH3 phase and may be funded for up to three additional years.

Eligibility Requirements
All organizations administering an eligible parent award may apply for a supplement under this NOFO. Eligible organizations include higher education institutions, nonprofits, for-profit organizations, local governments, state governments, federal government agencies, U.S. territories or possessions, Indian/Native American tribal governments (federally recognized), Indian/Native American tribal organizations (other than federally recognized tribal governments), faith-based or community-based organizations, regional organizations, non-domestic entities (organizations), foreign organizations, non-domestic components of U.S. Organizations.

Period of Performance
The maximum UG3 phase of the project duration is 2 years. The maximum UH3 phase of the project duration is 3 years.

Grant Value
$2,000,000 in FY 2025 to fund 3-5 awards. Application budgets are limited to $2M per year for direct costs.