Developing Digital Therapeutics for Substance Use Disorders (UG3/UH3 Clinical Trial optional)
Accelerating development of digital therapeutics for Substance Use Disorders to create FDA-authorized treatments utilizing technology-based platforms.
This grant is no longer accepting proposals
National Institutes of Health has archived this opportunity.
Funder: National Institutes of Health
Due Dates: June 17, 2025 (Letter of Intent) | July 17, 2025 (Application) | Oct 20, 2025 (LOI) | Nov 19, 2025 (Application) | Feb 24, 2026 (LOI) | Mar 26, 2026 (Application) | June 17, 2026 (LOI) | July 17, 2026 (Application) | Oct 20, 2026 (LOI) | Nov 19, 2026 (Application)
Funding Amounts: UG3: up to $500,000 direct costs/year (2 years); UH3: no set limit (up to 3 years); budgets must reflect project needs.
Summary: Supports phased development and testing of digital therapeutics for substance use disorders, aiming for FDA authorization and broad dissemination.
Key Information: Both pre-clinical and clinical projects are eligible; foreign and domestic organizations may apply; clinical trial is optional.
Description
This opportunity from the National Institutes of Health (NIH), led by the National Institute on Drug Abuse (NIDA), aims to accelerate the development of digital therapeutics (DTx) for the treatment of substance use disorders (SUDs). The program supports the creation and validation of clinical-grade mobile, web, or other software-based platforms that deliver safe and effective interventions for SUDs. The ultimate goal is to generate new, FDA-authorized digital treatments that can be widely disseminated to improve access and outcomes for individuals with SUDs.
The funding mechanism is a phased UG3/UH3 cooperative agreement. The UG3 phase (up to 2 years) supports milestone-driven development and feasibility work, while the UH3 phase (up to 3 years) provides additional support for projects that meet UG3 milestones, focusing on further development, clinical validation, and progression toward FDA authorization.
Projects may address pre-clinical and/or clinical development and testing of new DTx or repurposing of existing DTx for SUDs. Both stand-alone digital interventions and those integrated with FDA-approved SUD treatments are eligible.
