Sponsor Deadline
Posted: 3/20/2024

Device Based Treatments for Substance Use Disorders (UG3/UH3 Clinical Trial Optional)

The purpose of this notice of funding opportunity (NOFO) is to accelerate the development of devices to treat Substance Use Disorders (SUDs). The continuing advances in technologies offer unprecedented opportunities to develop neuromodulatory or neurophysiological devices that are safe and effective SUD treatments. The objective is to move devices to their next step in the FDA approval process, with the ultimate goal of generating new, FDA approved device-based treatments for SUDs.

Applications may focus on the pre-clinical and/or clinical development and testing of new devices or existing devices approved for other indications. Applications may evaluate the mechanism of action of a device.

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. UG3 projects that meet their milestones will be administratively considered by the National Institute on Drug Abuse and prioritized for transition to the UH3 phase. Investigators submitting to this NOFO must address both UG3 and UH3 phases.

Deadlines:

  • Letter of Intent Due Date(s): 30 days prior to the application due date
  • Application Due Date(s): December 18, 2023; Aug 13, 2024; Dec 18, 2024; Aug 13, 2025; Dec 18, 2025; Aug 13, 2026

PAR-23-253 Expiration Date August 14, 2026

Amount Description

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. The project period is limited to 2 years for the UG3 phase and 3 years for the UH3 phase