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

The National Institutes of Health (NIH), specifically the National Institute on Drug Abuse (NIDA), has released a Notice of Funding Opportunity (NOFO) titled "Developing Digital Therapeutics for Substance Use Disorders (UG3/UH3 Clinical Trial optional)" under the activity code UG3/UH3 Exploratory/Developmental Phased Award Cooperative Agreement. This grant is a reissue of PAR-21-183 and seeks to accelerate the development of Digital Therapeutics (DTx) aimed at treating Substance Use Disorders (SUDs). Digital Therapeutics refer to clinical-grade, software-based interventions designed to deliver behavioral therapies that traditionally require face-to-face clinician interaction. These interventions are expected to be scalable, accessible, and capable of maintaining treatment confidentiality. The primary goal of this funding opportunity is to develop and advance DTx technologies that can ultimately gain FDA authorization. The grant supports both pre-clinical and clinical stages of development, allowing applicants to propose new DTx or adaptations of existing ones designed for other indications. The phased funding mechanism involves a UG3 phase lasting up to two years, focusing on development with defined milestones, followed by a potential transition to the UH3 phase, which can provide up to three more years of funding for further development and clinical validation. Eligible applicants include a wide range of organizations such as higher education institutions, nonprofits, for-profit entities including small businesses, government agencies at various levels, public housing authorities, Native American tribal organizations, and foreign institutions. Applicants must follow NIH’s standard registration processes through systems such as SAM, Grants.gov, and eRA Commons. The application must cover both UG3 and UH3 phases with clear, quantitative milestones and go/no-go criteria. Activities under these phases may include finalizing the DTx platform, conducting proof-of-concept trials, obtaining FDA feedback through the Q-submission process, and filing an Investigational Device Exemption (IDE), if required. Applications must be submitted electronically through ASSIST, Grants.gov Workspace, or an institutional system-to-system solution. Letter of Intent is encouraged 30 days before each due date, though not required. Application cycles occur multiple times annually, with due dates in March, July, and November through 2026. The expiration date of the NOFO is May 24, 2025. Applicants are advised to consult with NIDA program staff during the application development process to ensure alignment with program priorities and feasibility of timelines. Scientific peer review and advisory council evaluations will assess applications based on significance, innovation, investigator capability, research approach, and environment. Reviewers will also consider regulatory planning, potential for FDA approval, and how well the intervention meets identified public health needs. For further information, applicants may contact Dr. Will M. Aklin at aklinwm@nida.nih.gov or 301-827-5909. Grants management questions should be directed to nidagmbemail@nida.nih.gov. General application queries can be addressed to GrantsInfo@nih.gov or the Grants.gov support team.