Pilot and Feasibility Studies in Preparation for Drug and Alcohol Abuse Prevention Trials (R34 Clinical Trial Optional) | PA 18 067

Opportunity Information: Apply for PA 18 067

The National Institutes of Health (NIH) funding opportunity titled "Pilot and Feasibility Studies in Preparation for Drug and Alcohol Abuse Prevention Trials (R34 Clinical Trial Optional)" (Funding Opportunity Number PA 18-067) is designed to help research teams generate the kind of early, practical evidence needed before moving into larger and more expensive prevention trials. It supports R34 grant applications focused on piloting and testing whether a prevention approach is workable, acceptable, and promising enough to justify a subsequent full-scale study. The core idea is to fund early-stage work that reduces uncertainty and strengthens the foundation for a later, larger prevention trial targeting drug and alcohol misuse and related harms.

The FOA emphasizes two main categories of projects. First, it supports pilot and feasibility testing of innovative prevention interventions, including approaches that are entirely new as well as ones that are revised or adapted from existing models. These interventions are expected to aim at preventing or delaying the initiation of drug or alcohol use, stopping or slowing progression from early use into problem use or substance use disorder, and reducing alcohol-related harms such as drinking and driving and deaths linked to impaired driving. It also includes prevention efforts that reduce drug- or alcohol-related risks for acquiring or transmitting HIV infection and viral hepatitis, reflecting NIH interest in the overlap between substance use, sexual and injection risk, and infectious disease outcomes. Second, the FOA supports pre-trial feasibility testing for prevention services and systems research, which generally means studying whether prevention programs can be implemented effectively through real-world service systems (for example, healthcare, schools, community agencies, or other delivery settings), and identifying the practical barriers and facilitators that will affect scalability.

A key feature of this R34 mechanism is that it is intended to produce early-stage efficacy, effectiveness, or services research data that serves as a prerequisite for a later, larger application. In practice, this often means collecting credible pilot data on issues like recruitment and retention of the target population, acceptability of the intervention to participants and staff, fidelity and quality of implementation, feasibility of data collection procedures, preliminary signals of impact on targeted outcomes, and operational requirements for running a larger trial. The announcement also notes that clinical trials are optional under this FOA, meaning applicants may propose a study that includes a clinical trial component if it fits the aims and remains clearly within the pilot/feasibility scope.

The FOA also draws a clear boundary around what it will not fund. It does not support applications where the only activity is developing intervention protocols, writing manuals, or standardizing procedures in isolation. Any intervention development work has to be embedded within an actual pilot or feasibility study that tests the approach in a real or realistic setting. In other words, the emphasis is on learning by trying the intervention in practice rather than producing materials alone.

Another highlighted priority is prevention interventions that target the healthcare system. This signals particular interest in approaches that can be integrated into medical settings, health service workflows, or healthcare-linked prevention pathways, such as screening and brief intervention models, referral processes, technology-enabled prevention supports connected to care, or systems-level strategies that increase prevention reach and effectiveness through clinical infrastructure.

Eligibility is broad, which is typical for NIH grant programs, and includes many types of domestic organizations such as state, county, and local governments; special district governments; independent school districts; public housing authorities; public and private institutions of higher education; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses) as well as small businesses; and federally recognized Native American tribal governments. The FOA also explicitly calls out additional eligible applicants and priority-relevant institutions and organizations, 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), Indian/Native American tribal governments that are not federally recognized, faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and non-U.S. entities (foreign organizations). This wide eligibility aligns with the FOA's emphasis on diverse populations and settings and encourages applications from organizations positioned to reach communities with distinct needs and contexts.

From the source details provided, the opportunity is categorized as a discretionary grant under NIH, with activity categories listed as education and health, and CFDA numbers 93.273 and 93.279. The record shows an original closing date of May 7, 2018, and a creation date of November 15, 2017. While the summary information lists an award ceiling and expected awards as not specified in the provided extract, the overall intent is clear: to fund limited, preparatory studies that de-risk larger prevention trials by producing actionable feasibility and pilot evidence, particularly for interventions that can prevent substance use initiation, reduce escalation and related harms, and address substance-related HIV and viral hepatitis risks across varied communities and real-world delivery systems.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Pilot and Feasibility Studies in Preparation for Drug and Alcohol Abuse 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 2017-11-15.
• Applicants must submit their applications by 2018-05-07. (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.

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