Developing Digital Therapeutics for Substance Use Disorders (UG3/UH3 Clinical Trial optional)

Background
The National Institute on Drug Abuse (NIDA), a component of the National Institutes of Health (NIH), is offering a funding opportunity to accelerate the development of Digital Therapeutics (DTx) to treat Substance Use Disorders (SUDs). The primary objective is to move DTx to their next step in the development process, with the ultimate goal of generating new, FDA authorized, disseminated treatments for SUDs.

Grant Details
The UG3/UH3 Cooperative Agreement involves two phases. The UG3 phase, for up to two years, is designed to support a project with specific milestones to be accomplished by the end of the period. The UH3 phase is to provide funding for up to three additional years following successful completion of the UG3. Applications may focus on the pre-clinical and/or clinical development and testing of new DTx or existing DTx developed for other indications.

The UG3 phase should focus on moving the intervention forward to the next stage of design and testing, providing milestones relevant to the FDA authorization pathway. The UH3 phase supports the next step in the development of the intervention and progression towards FDA authorization.

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, government agencies, and foreign entities. Individuals from diverse backgrounds are encouraged to apply.

Period of Performance
The project period is limited up to two years for the UG3 phase and up to three years for the UH3 phase.

Grant Value
Application budgets are limited to $500,000 direct costs for each year of the UG3 phase, but are not limited for the UH3 phase. However, budgets need to reflect the actual needs of the proposed project.