Pilot and Feasibility Studies in Preparation for Substance Use Prevention Trials (R34 Clinical Trial Optional) | PA 21 110

Opportunity Information: Apply for PA 21 110

Pilot and Feasibility Studies in Preparation for Substance Use Prevention Trials (R34 Clinical Trial Optional) is a National Institutes of Health (NIH) discretionary grant opportunity designed to help researchers and community partners do the early, practical work needed before launching larger, full-scale substance use prevention trials. The central goal is to fund pilot and feasibility studies that strengthen the evidence base and implementation readiness of prevention approaches, so that future, larger studies can be designed with more confidence about what works, for whom, and under what real-world conditions.

The FOA supports two broad types of projects. First, it funds the development and pilot testing of new interventions, as well as the adaptation and pilot testing of existing interventions, aimed at preventing or delaying the start of substance use and reducing the chance that early use escalates into misuse or a substance use disorder. Second, it supports pre-trial feasibility, acceptability, and readiness testing for services and service-system research that is relevant to substance use prevention. In practice, that can include work like testing recruitment and retention strategies, refining delivery methods, evaluating how acceptable an intervention is to participants and providers, assessing whether settings such as schools, clinics, or community organizations can realistically deliver the program, and identifying implementation barriers that could derail a later, larger trial.

While the main emphasis is prevention of substance use, misuse, and disorder, the NIH also highlights related outcomes that matter to public health and safety. Projects may focus on reducing negative downstream consequences associated with substance use, including deaths related to impaired driving, suicidal behavior (including both nonfatal and fatal attempts), and drug- or alcohol-related acquisition or transmission of HIV infection and viral hepatitis. The opportunity explicitly encourages work across diverse populations and settings, signaling interest in studies that are attentive to local context, equity, and the needs of communities that may face higher risk or fewer prevention resources.

This announcement uses the R34 mechanism and is labeled “Clinical Trial Optional,” meaning applicants can propose either projects that do not include a clinical trial or, if appropriate for the aims, projects that do include a clinical trial component. The funding instrument is a grant, and the activity area is listed under education and health. The CFDA number is 93.279, which corresponds to NIH research support in this topic space.

A wide range of organizations are eligible to apply. 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 other than federally recognized tribal governments; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); small businesses; and other entities. The FOA also calls out additional 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, non-U.S. (foreign) organizations, regional organizations, tribal governments that are not federally recognized, and U.S. territories or possessions. This breadth is meant to encourage prevention research that is grounded in many kinds of institutions, including community-rooted organizations and settings where prevention can be delivered at scale.

Key administrative details from the listing include the funding opportunity number PA-21-110, an original closing date of 2024-01-07, and an award ceiling of $225,000. The opportunity was created on 2021-01-13. The listing does not specify the number of expected awards, suggesting it may vary depending on NIH priorities, availability of funds, and the quality of applications received.

Overall, the opportunity is best suited for teams that are not yet ready for a large, definitive prevention trial but have a strong concept that needs careful early testing. Competitive projects typically use the pilot period to finalize intervention content or delivery, demonstrate feasibility and acceptability, refine measures and procedures, and generate preliminary data that make a later, larger prevention trial more rigorous, realistic, and likely to succeed in real-world settings.

• 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): 93.279.
• This funding opportunity was created on 2021-01-13.
• Applicants must submit their applications by 2024-01-07. (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 $225,000.00 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.

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