Pilot Health Services and Economic Research on the Treatment of Drug, Alcohol, and Tobacco Use Disorders (R34 Clinical Trial Optional) | PAR 25 100

Opportunity Information: Apply for PAR 25 100

The National Institutes of Health (NIH) is soliciting applications under Funding Opportunity PAR-25-100, titled "Pilot Health Services and Economic Research on the Treatment of Drug, Alcohol, and Tobacco Use Disorders (R34 Clinical Trial Optional)." This is a discretionary grant mechanism using the NIH R34 activity code, which is typically used to support early-stage, pilot, and feasibility work that sets the stage for a later, larger-scale study. The overall aim of this opportunity is to fund preparatory research that helps investigators build a strong foundation for future services research effectiveness trials focused on substance use disorder treatment and related service systems.

At its core, the NOFO is designed for projects that test, refine, or otherwise evaluate approaches meant to improve how treatment and recovery-related services are delivered for drug, alcohol, and tobacco use disorders. The scope is intentionally broad. Proposed pilot trials can examine clinical interventions, routine care practices, program models, and policy-level strategies. The emphasis is on practical, real-world improvements such as increasing access to care, improving quality and effectiveness, reducing costs or improving affordability, and optimizing utilization (for example, improving engagement, retention, appropriate intensity of services, and continuity of care). The NOFO also explicitly recognizes that substance use disorders frequently co-occur with medical conditions and mental health disorders, and it welcomes projects that address services for these comorbidities as part of the care approach.

A key feature of this funding opportunity is that it supports both innovation and the evaluation of commonly used strategies that have not yet been backed by rigorous evidence. In other words, applicants do not need to propose something entirely new; they can also propose to test approaches that are already widespread in practice but remain under-studied. Because this is a pilot-focused mechanism, the NOFO prioritizes work that directly informs whether a larger effectiveness trial is realistic and worthwhile. That includes generating evidence about feasibility (whether the approach can be implemented as intended in the target setting), acceptability (whether patients, clinicians, organizations, or communities view the approach as appropriate and workable), and utility (whether the approach produces useful signals that justify scaling up, such as promising service outcomes, implementation outcomes, or cost-related insights). Alongside these pilot outcomes, the NOFO supports standard trial preparation activities, such as refining protocols, improving recruitment and retention strategies, testing data collection workflows, ensuring outcome measures are appropriate and reliable, and establishing partnerships and operational readiness for a future larger study.

The "clinical trial optional" designation means applicants may propose studies that do or do not meet the NIH definition of a clinical trial, depending on the research question and design. This flexibility allows the funding to support a range of preparatory projects, from pilot randomized or pragmatic trials to other early-stage evaluations aimed at informing a subsequent effectiveness trial in health services research.

Eligibility is broad and includes many types of domestic organizations and governmental units. Eligible applicants listed include state, county, city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations other than federally recognized governments; public housing authorities and Indian housing authorities; and nonprofits both with and without 501(c)(3) status (excluding institutions of higher education under those nonprofit categories). For-profit organizations (other than small businesses) and small businesses may also apply, as well as other categories captured under "Others." The NOFO further highlights additional eligible applicants 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, regional organizations, eligible federal government agencies, U.S. territories or possessions, Indian/Native American Tribal Governments other than federally recognized entities, and even non-U.S. (foreign) organizations.

Administrative details provided include the associated CFDA number 93.279 and the activity categories listed as education and health. The opportunity was created on 2024-12-06, and the original closing date is 2027-05-07, indicating a multi-year window during which NIH expects to accept submissions according to the NOFO's specified receipt dates and cycles. The award ceiling and expected number of awards are not specified in the provided source data, which often means applicants need to consult the full NOFO text for budget guidance, project period expectations, and any institute- or program-specific funding considerations.

In practical terms, this opportunity is best suited for teams that have a promising service delivery, implementation, or policy approach related to substance use disorder treatment, but need pilot data to demonstrate that the approach can be carried out in real settings and that it produces meaningful, measurable signals (including potential economic or cost-related implications) before investing in a larger, definitive effectiveness trial.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Pilot Health Services and Economic Research on the Treatment of Drug, Alcohol, and Tobacco Use Disorders (R34 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 2024-12-06.
• Applicants must submit their applications by 2027-05-07.
• 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 25 100

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