Exploratory Clinical Neuroscience Research on Substance Use Disorders (R61/R33 Clinical Trial Optional) | PAR 19 282

Opportunity Information: Apply for PAR 19 282

This grant opportunity, titled "Exploratory Clinical Neuroscience Research on Substance Use Disorders (R61/R33 Clinical Trial Optional)" (Funding Opportunity Number PAR 19 282), is a National Institutes of Health (NIH) discretionary grant designed to push forward early stage clinical neuroscience research focused on substance use disorders (SUD). The central aim is to support projects that are still exploratory or developmental but have strong potential to clarify the neurobiological mechanisms that drive SUD, including basic aspects of brain function that relate directly to substance use and addiction. In practical terms, the FOA is looking for clinical research that helps explain how the brain changes with substance use, what brain systems are involved in addiction related behaviors, and what measurable neural processes might explain risk, craving, withdrawal, relapse, or recovery.

A defining feature of the program is its use of the R61/R33 Phased Innovation Award mechanism. This structure is meant for projects that need an initial, tightly defined development phase (R61) followed by a second phase (R33) that expands or confirms the work once early milestones are met. The phased design is commonly used when a study has some scientific promise but still requires key feasibility, measurement, recruitment, or methodological proof points before it can responsibly move into a larger or more definitive stage. Rather than forcing investigators to propose an all-or-nothing project, the R61/R33 format supports a stepwise approach where the first phase generates the evidence needed to justify continued investment. This is especially relevant for clinical neuroscience studies that may involve complex protocols, specialized assessments, or novel measurement approaches.

The FOA also highlights that it is intended for projects that are larger in budget scope than what is typically allowed under the R21 mechanism. In other words, it targets research that is still exploratory in spirit but may be too resource-intensive for an R21 because it involves more extensive clinical procedures, advanced neuroscience methods, or larger and more demanding study designs. The emphasis is not on funding a full scale confirmatory trial from the outset, but on enabling ambitious early clinical neuroscience work that can produce clear go/no-go outcomes and generate rigorous evidence about mechanisms.

Clinical trials are listed as optional, meaning applicants may propose studies that do or do not meet the formal definition of a clinical trial. This flexibility allows for a range of human subject research, including mechanistic clinical studies, experimental medicine approaches, or clinical protocols that test how changes in brain function relate to substance use behaviors, symptoms, or treatment response. The key unifying requirement is that the work stays focused on understanding neurobiology and brain based mechanisms relevant to SUD.

In terms of administrative details, this is a grant funding instrument in the Education and Health activity category and is associated with CFDA number 93.279. The opportunity was created on 2019-05-15, and the original closing date listed in the provided data is 2023-05-07. While an "award ceiling" and "expected awards" are not specified in the provided listing, the overall intent is clearly to support projects whose needs exceed R21 limits, which signals an interest in appropriately resourced, methodologically robust exploratory studies.

Eligibility is broad and includes many types of U.S. organizations and governments, such as state, county, city or township governments, special district governments, independent school districts, and public housing authorities/Indian housing authorities. Academic eligibility includes public and state-controlled institutions of higher education and private institutions of higher education. The FOA also allows participation from Native American tribal governments (federally recognized) and Native American tribal organizations (other than federally recognized tribal governments). Nonprofits are eligible whether or not they hold 501(c)(3) status, as are for-profit organizations (other than small businesses) and small businesses. The announcement further calls out additional eligible groups, including 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 federal agencies, regional organizations, U.S. territories or possessions, and even non-U.S. entities (foreign organizations). That wide eligibility list is important because it signals an interest in supporting diverse research settings and populations, which can be particularly valuable for neuroscience research on SUD given the uneven burden of addiction across communities and regions.

Overall, the opportunity is best understood as NIH support for high-potential clinical neuroscience projects that are not yet ready for a large definitive program but are too substantial for small exploratory mechanisms. It encourages researchers to propose careful, milestone-driven work that can reveal how substance use disorders operate in the brain, using a phased structure that reduces risk while still enabling sophisticated, clinically grounded neuroscience.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Exploratory Clinical Neuroscience Research on Substance Use Disorders (R61/R33 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 2019-05-15.
• Applicants must submit their applications by 2023-05-07. (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.

Apply for PAR 19 282

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