Mechanistic Research on Neuromodulation for Substance Use Disorders Treatment (R01 Clinical Trial Optional) | RFA DA 24 031

Opportunity Information: Apply for RFA DA 24 031

Mechanistic Research on Neuromodulation for Substance Use Disorders Treatment (R01 Clinical Trial Optional) is a National Institutes of Health (NIH) grant opportunity (Funding Opportunity Number RFA-DA-24-031; CFDA 93.279) aimed at advancing clinical research on non-invasive brain stimulation (NIBS) approaches for substance use disorders (SUDs). The central focus is not simply whether a neuromodulation intervention "works" in terms of end outcomes, but why and how it works. Projects are expected to identify and validate novel brain-based targets for NIBS and to map the SUD-relevant neurobiological, cognitive, and behavioral responses that occur after stimulation and before downstream clinical changes, such as reduced craving or reduced drug use. The goal is to sharpen the field's understanding of mechanisms so that future treatments can be more precise, more effective, and more tailored to the underlying drivers of addiction-related behavior.

A key emphasis of the NOFO is on mechanistic clinical research that can link stimulation of specific neural circuits to measurable intermediate changes. In practice, this means investigators are encouraged to study response pathways that plausibly mediate later clinical improvement, such as changes in brain activity or connectivity, inhibitory control, reward processing, stress responsivity, cue reactivity, decision-making, learning, or other behavioral and cognitive processes known to be implicated in SUDs. The opportunity supports research that tests and validates new stimulation targets and examines the immediate and proximal effects of NIBS on these mechanistic readouts, with the idea that these early signals can help predict or explain later outcomes like decreased craving or use. The "clinical trial optional" designation signals that applicants may propose a clinical trial if it is appropriate for the mechanistic aims, but a trial is not automatically required for every project; the design should match the scientific question.

This is an R01 grant mechanism, meaning it is intended for substantial, hypothesis-driven projects with a clear rationale, rigorous methodology, and the resources to execute a multi-year research plan. The NOFO is categorized as a discretionary grant opportunity in the education and health activity area. The original closing date listed is 2026-08-14, and the opportunity was created on 2023-09-28. While the listing includes an "Award Ceiling" field, no ceiling amount is specified in the provided source details, and the "Expected Awards" field is also not populated in the provided information.

A major administrative requirement in this NOFO is the Plan for Enhancing Diverse Perspectives (PEDP). This is not optional and not a generic statement: it is a required component that will be evaluated during scientific and technical peer review. If an application does not include a PEDP, it will be considered incomplete and will be withdrawn without review. Applicants are explicitly urged to follow the NOFO's PEDP instructions carefully and to consult the associated PEDP guidance materials. In practical terms, this means the application should lay out concrete, credible steps for incorporating diverse perspectives into the research process, which can include (depending on the project) diversity in research teams, participant populations, study settings, community or stakeholder engagement, and approaches that broaden the relevance and interpretability of mechanistic findings across populations and contexts.

Eligibility is broad and spans many organizational types. Eligible applicants include state, county, city or township governments, special district governments, and independent school districts; public and state-controlled institutions of higher education as well as private institutions of higher education; federally recognized Native American tribal governments and tribal organizations (including those other than federally recognized tribal governments); public housing authorities and Indian housing authorities; nonprofits with or without 501(c)(3) status (excluding institutions of higher education in those nonprofit categories); for-profit organizations other than small businesses; small businesses; and other entities as allowed by NIH. The NOFO also highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISIs); Hispanic-serving institutions; Historically Black Colleges and Universities (HBCUs); Tribally Controlled Colleges and Universities (TCCUs); faith-based or community-based organizations; eligible agencies of the federal government; regional organizations; U.S. territories or possessions; and non-domestic (non-U.S.) entities, meaning foreign organizations may also apply where NIH policy permits.

Overall, this opportunity is designed for teams that can combine neuromodulation expertise with strong clinical and mechanistic measurement strategies in SUD populations. The best-aligned proposals will clearly justify the stimulation target, define measurable intermediate outcomes that are plausibly on the causal path to clinical benefit, and use a rigorous clinical research design to validate those mechanisms, all while meeting the PEDP requirement in a substantive way that strengthens the science and its generalizability.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Mechanistic Research on Neuromodulation for Substance Use Disorders Treatment (R01 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 2023-09-28.
• Applicants must submit their applications by 2026-08-14. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• 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.

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