Clinical Development of Minimally-Invasive Bioassays to Support Outpatient Clinical Trials of Therapeutics for Substance Use Disorders (R01 Clinical Trial Optional) | PA 18 056

Opportunity Information: Apply for PA 18 056

The funding opportunity titled "Clinical Development of Minimally-Invasive Bioassays to Support Outpatient Clinical Trials of Therapeutics for Substance Use Disorders (R01 Clinical Trial Optional)" (Funding Opportunity Number PA 18-056) is a National Institutes of Health (NIH) discretionary grant program designed to strengthen the development and clinical evaluation pipeline for medications targeting Substance Use Disorders (SUDs). It uses the NIH Research Project Grant (R01) mechanism and specifically encourages applicants to create and clinically develop minimally invasive or non-invasive bioassays that can be used in outpatient clinical trial settings. The core aim is practical: improve how researchers measure drug exposure, treatment adherence, substance use, and related biological signals during outpatient pharmacotherapy trials, where frequent clinic visits and traditional specimen collection can be burdensome and can reduce retention and data quality.

At a high level, the FOA is focused on tools and methods that make outpatient trials more feasible and scientifically rigorous. Outpatient SUD trials often struggle with challenges such as missed visits, unreliable self-report, difficulties confirming recent substance use, and the logistical complexity of collecting conventional biospecimens (for example, venous blood draws) repeatedly over time. By supporting minimally invasive bioassays, the program is essentially trying to make it easier to run high-quality clinical studies in real-world or near-real-world conditions, where participants live at home and treatment occurs with less intensive monitoring than in inpatient research settings.

The kinds of approaches implied by the announcement include non-invasive or low-burden biological measurements that can be collected in outpatient environments, potentially including at-home collection or collection in community clinics. While the announcement text provided does not list specific technologies, the phrase "non-invasive methods" in this context commonly points toward biospecimens and measurement strategies such as saliva, breath, sweat, urine alternatives, hair, interstitial fluid sampling approaches, wearable or patch-based sampling, or other techniques that reduce the need for phlebotomy or intensive clinic-based procedures. The emphasis is not only on inventing an assay in the lab, but on clinical development and demonstrating that it can support outpatient pharmacotherapy trials for SUDs in a reliable, usable way.

The grant is categorized under Education and Health and is associated with CFDA number 93.279. The award ceiling is listed as $500,000, indicating the maximum amount expected per award (typically interpreted as a per-year direct cost cap only if explicitly stated in the FOA, though the provided text does not clarify whether this ceiling is per year or total). The FOA is labeled "Clinical Trial Optional," meaning applicants may propose studies that include a clinical trial component if it is appropriate for the bioassay development and validation work, but a clinical trial is not strictly required for every application. This structure is meant to accommodate a range of projects, from clinical validation studies to integration of a bioassay into an outpatient therapeutic trial workflow.

Eligibility is broad and intentionally inclusive, covering many organization types that could contribute to this kind of translational clinical methods work. Eligible applicants include state, county, and local 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 that are not federally recognized; public housing authorities and Indian housing authorities; nonprofits with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); and small businesses. In addition, the FOA explicitly highlights other 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, eligible federal agencies, regional organizations, U.S. territories or possessions, and non-U.S. entities (foreign organizations). Taken together, this suggests NIH is encouraging participation from both traditional academic research centers and community-rooted or mission-driven organizations that may be well positioned to conduct outpatient research with SUD populations.

Administrative details in the source data show the FOA was created on 2017-11-02 and lists an original closing date of 2018-09-07. Those dates indicate the announcement originates from a past cycle; however, the program description is still useful as a summary of NIH priorities in this area, and similar FOAs are sometimes reissued or continued under updated numbers. The expected number of awards is not provided in the excerpt, which often means awards depend on application volume, merit, and available appropriations.

In practical terms, a strong application under this FOA would be expected to explain a clear clinical need in outpatient SUD pharmacotherapy trials, propose a minimally invasive bioassay that addresses that need, and lay out a credible plan for development, analytical validation, and clinical validation in the intended setting. Reviewers would typically look for evidence that the assay can perform reliably under real outpatient conditions, that it is acceptable and feasible for participants and study staff, and that it meaningfully improves the ability of clinical trials to evaluate therapeutics for SUDs by producing more accurate, timely, or interpretable biological data than existing approaches.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Clinical Development of Minimally-Invasive Bioassays to Support Outpatient Clinical Trials of Therapeutics for Substance Use Disorders (R01 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 2017-11-02.
• Applicants must submit their applications by 2018-09-07. (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 $500,000.00 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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