Device Based Treatments for Substance Use Disorders (UG3/UH3 Clinical Trial Optional) | PAR 25 023

Opportunity Information: Apply for PAR 25 023

The NIH funding opportunity "Device Based Treatments for Substance Use Disorders (UG3/UH3 Clinical Trial Optional)" (Funding Opportunity Number PAR-25-023) is a discretionary cooperative agreement designed to speed up the development of medical devices intended to treat substance use disorders (SUDs). The central idea behind the announcement is that recent progress in technology, especially in neuromodulation and neurophysiological monitoring, has created practical openings to build device-based interventions that are both safe and effective for people with SUDs. Rather than supporting basic discovery work, this program is aimed at pushing promising device candidates forward along the translational path so they are ready for their next step in the U.S. Food and Drug Administration (FDA) approval process. The long-term endpoint NIH is signaling is straightforward: a stronger pipeline of new, FDA-approved, device-based treatments for SUDs.

This FOA uses the UG3/UH3 phased award structure, which generally supports a milestone-driven progression from an earlier, preparatory stage (UG3) into a later stage (UH3) where more advanced development and, when appropriate, clinical evaluation can occur. The notice also indicates that clinical trials are optional, meaning applicants may propose projects that include a clinical study component if it is justified for the maturity of the device and its regulatory pathway, but applicants are not required to include a clinical trial to be responsive. As a cooperative agreement, the mechanism also implies a more hands-on partnership with NIH program staff than a standard grant, typically with active federal involvement in shaping, monitoring, or coordinating aspects of the project as it moves through defined milestones and deliverables.

In terms of what NIH is trying to fund, the emphasis is on devices that intervene through neuromodulatory or neurophysiological approaches, reflecting the reality that SUDs involve identifiable brain and physiological circuits that can potentially be modulated or monitored to reduce craving, withdrawal symptoms, relapse risk, or other clinically meaningful outcomes. The program language focuses on accelerating "development," which usually includes activities like engineering refinement, usability and safety work, verification and validation testing, planning and execution of studies needed to support regulatory submissions, and generating the kind of evidence base the FDA expects for a device moving toward clearance or approval. The explicit mention of advancing devices to their "next step" in the FDA process is a strong cue that projects should be framed with regulatory strategy in mind, including how the proposed work will directly reduce risk and fill evidence gaps required for the next regulatory milestone.

Eligibility is broad and includes a wide range of public and private organizations. Eligible applicants span state, county, city or township, and special district governments, as well as independent school districts and public housing authorities/Indian housing authorities. Academic institutions are eligible, including public and state-controlled institutions of higher education and private institutions of higher education. The FOA also welcomes federally recognized Native American tribal governments and tribal organizations that are not federally recognized, along with a wide set of nonprofit organizations (both those with 501(c)(3) status and those without, as long as they are not institutions of higher education in those categories). For-profit organizations are eligible, including small businesses and other for-profits that are not small businesses, which is notable because device development often occurs in commercial settings. The announcement additionally highlights other eligible applicant types such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, U.S. territories or possessions, regional organizations, and even non-U.S. entities (foreign organizations), indicating an intent to draw from diverse institutional strengths and encourage broad participation.

Administratively, the opportunity is issued by the National Institutes of Health under CFDA number 93.279 and uses the cooperative agreement funding instrument. The original closing date listed is 2026-08-13, giving prospective applicants a clear deadline target in the current cycle. The listed award ceiling is $500,000, which signals an upper bound on per-award funding under this opportunity as presented in the source data. The expected number of awards is not specified in the provided listing, which is common in some federal postings where the final number depends on available appropriations and the quality of applications received. The opportunity record shows a creation date of 2024-07-12, which helps place the announcement in time relative to NIH program priorities and planning horizons.

Taken together, PAR-25-023 is best understood as a translational, milestone-oriented NIH program meant to bring credible device concepts for SUD treatment closer to real-world clinical use by aligning development work with FDA expectations. Applicants that fit well are typically those who already have a plausible device concept or prototype and can make a compelling case that the proposed project will generate the technical, safety, performance, and potentially clinical evidence needed to advance to the next regulatory step, ultimately supporting the broader goal of expanding FDA-approved device-based options for treating substance use disorders.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Device Based Treatments for Substance Use Disorders (UG3/UH3 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.279.
• This funding opportunity was created on 2024-07-12.
• Applicants must submit their applications by 2026-08-13. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $500,000.00 in funding.
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for PAR 25 023

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: