The funding opportunity "Developing Digital Therapeutics for Substance Use Disorders" (PAR-24-064) is a grant initiative by the National Institutes of Health (NIH) aimed at advancing the development of digital therapeutics (DTx) to treat Substance Use Disorders (SUDs). The program employs a UG3/UH3 phased cooperative agreement mechanism, which allows for optional clinical trials and supports a seamless transition from preclinical development (UG3 phase) to clinical testing and further development (UH3 phase). The goal of this initiative is to create digital platforms, such as mobile apps, web-based interventions, or other software-based tools, that can deliver safe and effective treatment for SUDs, potentially achieving FDA authorization and broader dissemination.

Eligible applicants include a variety of entities, such as public and private institutions of higher education, small businesses, for-profit organizations, state and local governments, tribal organizations, nonprofits, and special district governments. This inclusivity extends to minority-serving institutions like Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, and Tribally Controlled Colleges and Universities (TCCUs). Foreign organizations are not eligible to apply directly, though they may be included as components under certain conditions.

The program encourages the development of innovative digital solutions that can either be entirely new or adapted from existing digital therapeutics designed for other medical conditions. The aim is to leverage technological advances to address the significant treatment gap in SUDs by providing accessible, scalable, and clinically validated digital treatment options. While obtaining FDA authorization is a key objective, the program also acknowledges alternative pathways for bringing digital therapeutics to market.

The phased UG3/UH3 mechanism ensures that projects meet predefined milestones before advancing from preclinical development (UG3 phase) to clinical evaluation and further development (UH3 phase). This approach minimizes risk by allowing early termination of projects that do not meet safety or feasibility criteria. Projects may focus on various stages of development, including software design, user interface optimization, initial safety testing, efficacy studies, and regulatory preparations.

There is no specified award ceiling or floor for this funding opportunity, providing flexibility for applicants to propose budgets appropriate for the scale and scope of their projects. The application deadline is November 19, 2026, allowing ample time for prospective applicants to develop well-prepared proposals. The cooperative agreement format indicates that the NIH will work closely with awardees, providing substantial guidance and support throughout the project.