Accelerate development of safe & effective device treatments for Substance Use Disorders to advance toward FDA approval for innovative SUD therapies.
Funder: National Institutes of Health (NIH)
Due Dates: August 13, 2025 | December 18, 2025 | Final deadline November 24, 2025
Funding Amounts: Up to $500,000 direct costs per year (UG3 phase, up to 2 years); UH3 phase (up to 3 years) not limited but must reflect project needs.
Summary: Supports the phased development and clinical testing of neuromodulatory or neurophysiological devices as treatments for substance use disorders, aiming to advance devices toward FDA approval.
Key Information: Clinical trial optional; UG3/UH3 phased cooperative agreement; final application deadline is November 24, 2025.
This opportunity from the NIH, led by the National Institute on Drug Abuse (NIDA), aims to accelerate the development and clinical translation of device-based treatments for substance use disorders (SUDs). The program supports both pre-clinical and clinical research on neuromodulatory or neurophysiological devices, including those already approved for other indications, with the goal of moving promising devices to the next step in the FDA approval process. Projects must address both the exploratory (UG3) and implementation (UH3) phases, with clear milestones for transition.