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

The National Institutes of Health (NIH), through its National Institute on Drug Abuse (NIDA), issued this funding opportunity announcement to accelerate the development of neuromodulatory or neurophysiological devices as treatments for Substance Use Disorders (SUDs). These disorders continue to cause significant societal and financial strain in the United States, with limited treatment options for certain drugs such as methamphetamine, cocaine, cannabis, and for individuals with polysubstance use. The opportunity encourages applicants to advance new or existing devices toward FDA approval, addressing a vital public health challenge. This phased cooperative agreement (UG3/UH3) supports device development in two stages. The UG3 phase, lasting up to two years, focuses on establishing foundational evidence such as target engagement, safety, and early efficacy. The UH3 phase, contingent upon successful UG3 milestones, provides up to three additional years for more advanced validation, including clinical outcomes and broader behavioral effects. Projects should detail both stages in the initial submission and include clear, quantitative milestones for evaluating transition readiness between phases. Eligible research includes a wide range of device types such as transcranial magnetic stimulation, deep-brain stimulation, focused ultrasound, and others. Applications may involve either newly developed technologies or those already approved for other medical indications. Understanding the mechanism of action, including circuit-level brain effects and behavioral responses, is a central priority. Applications should integrate objective outcome measures, dosing details, and if applicable, sex-based response evaluations. Sham controls are required where feasible, and compliance tracking methods are encouraged when combining device and behavioral/pharmacological treatments. Funding for the UG3 phase is limited to $500,000 in direct costs annually, with no fixed limit for the UH3 phase, though budgets must reflect actual project needs. Projects must align with regulatory requirements and include IDE documentation or plans, as appropriate. Applications must adhere strictly to NIH submission protocols and follow updated Data Management and Sharing Policies. Although now expired, NIH may accept late submissions on a case-by-case basis under specific circumstances; applicants are advised to consult the eRA Service Desk for guidance. The opportunity was originally posted on July 12, 2024, with the earliest submission date of July 14, 2025. Standard due dates included August 13, 2025; December 18, 2025; and August 13, 2026, all by 5:00 PM local time. Letters of intent were due 30 days before each submission deadline. The program officially expired on November 24, 2025, per Notice NOT-DA-25-042, with applicants directed to check for future opportunities in the NIH Guide. Scientific questions can be directed to Will Aklin or Katrina Foster at NIDA, while submission issues should be routed to the eRA Service Desk.