Pilot and Feasibility Studies in Preparation for Substance Use Prevention Trials (R34 Clinical Trial Optional) | PAR 24 060

Opportunity Information: Apply for PAR 24 060

The NIH grant opportunity titled "Pilot and Feasibility Studies in Preparation for Substance Use Prevention Trials (R34 Clinical Trial Optional)" (Funding Opportunity Number PAR-24-060) supports early-stage research that helps investigators get ready for larger, full-scale substance use prevention trials. It is designed for pilot and feasibility work rather than definitive effectiveness testing, with the goal of strengthening the evidence base, refining approaches, and working out practical implementation issues before investing in a major trial.

The FOA prioritizes two main types of projects. First, it encourages the development and pilot testing of new interventions, as well as meaningful adaptations of existing interventions, intended to prevent or delay the start of substance use or to prevent progression from initial use into misuse or a diagnosable substance use disorder. Second, it supports pre-trial feasibility and acceptability studies focused on prevention-related services and service systems, which can include testing whether a prevention approach fits within real-world delivery settings, whether stakeholders and participants will engage with it, and whether the procedures needed for a later trial are workable. The "Clinical Trial Optional" designation indicates that applicants may propose studies that meet the definition of a clinical trial if appropriate, but they are not required to do so.

While the central focus is prevention of substance use, misuse, and substance use disorders, the FOA also explicitly recognizes broader public health outcomes that are closely tied to substance use. Projects may target reductions in downstream harms and negative sequelae, including deaths related to impaired driving, suicidal behavior (including both nonfatal and fatal attempts), and drug- or alcohol-related acquisition or transmission of HIV and viral hepatitis. A key theme is relevance across diverse populations and settings, signaling interest in prevention strategies that can work in different communities, contexts, and service environments.

Eligibility is broad and includes many types of organizations that can credibly carry out pilot and feasibility research. Eligible applicants include state, county, city/township, and 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 that are not federally recognized; public housing authorities and Indian housing authorities; nonprofit organizations with or without 501(c)(3) status; for-profit organizations (other than small businesses) as well as small businesses; and other entities. The FOA additionally highlights a range of eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), 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. (foreign) organizations, reflecting an intent to include a wide mix of research and community partners.

The awarding agency is the National Institutes of Health, and the opportunity is listed as a discretionary grant within the Education and Health activity categories, associated with CFDA numbers 93.273 and 93.279. The posting indicates an original closing date of January 7, 2027, and the opportunity was created on January 8, 2024. The notice does not specify an award ceiling or expected number of awards in the provided source information, so applicants would typically confirm budget and project period details in the full FOA text and any linked NIH institute-specific guidance.

Overall, this FOA is a fit for teams that have a strong prevention concept but need preliminary data, refined protocols, stakeholder input, feasibility metrics, recruitment and retention lessons, acceptability evidence, or service-system readiness work to justify and design a subsequent, rigorous prevention trial aimed at reducing substance initiation, escalation, and related harms.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Pilot and Feasibility Studies in Preparation for Substance Use Prevention Trials (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): 93.273, 93.279.
• This funding opportunity was created on 2024-01-08.
• Applicants must submit their applications by 2027-01-07.
• 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.

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