HEAL Initiative: Multilevel Interventions to Reduce Harm and Improve Quality of Life for Patients on Long Term Opioid Therapy (MIRHIQL) (R01 Clinical Trial Required) | RFA DA 23 041

Opportunity Information: Apply for RFA DA 23 041

The HEAL Initiative funding opportunity titled "Multilevel Interventions to Reduce Harm and Improve Quality of Life for Patients on Long Term Opioid Therapy (MIRHIQL)" is an NIH R01 grant mechanism that requires a clinical trial. It focuses on a specific, often hard-to-define group of patients: people who are on long-term opioid therapy (typically for chronic pain) and who show harmful opioid-related behaviors or signs of elevated risk, but who do not meet diagnostic criteria for opioid use disorder (OUD). The central goal is to develop and test multilevel interventions that reduce harm and improve patients quality of life, without defaulting to an all-or-nothing framing that either assumes OUD or ignores risk entirely. The opportunity is part of NIHs HEAL (Helping to End Addiction Long-term) Initiative, and it is associated with NEPS Concept Number 2393.

A key feature of the announcement is its emphasis on "multilevel" solutions, meaning applicants are expected to go beyond a single intervention at the individual patient level. Proposed projects can incorporate multiple layers such as patient-centered clinical strategies, provider behavior and decision support, clinic workflow redesign, health system policies, care coordination, payer or benefit design considerations, and community-based supports. The intent is to find practical combinations of approaches that can be implemented in real healthcare settings and that meaningfully reduce opioid-related harms (for example unsafe use patterns, medication mismanagement, adverse events, risky co-prescribing, escalating dose trajectories, functional decline, or other negative outcomes) while also protecting pain-related functioning, mental health, and overall well-being.

The funding opportunity also places strong importance on patient engagement, specifically stating that patients with lived experience should be involved as consultants on these projects. In practice, this means applicants should plan for structured input from people who have direct experience with long-term opioid therapy and its risks, including participation in study design, recruitment and retention strategies, intervention acceptability, outcome selection, and interpretation of results. This requirement reflects a broader expectation that interventions and measures should align with what patients consider meaningful and should avoid stigmatizing or overly punitive approaches that could worsen care engagement or outcomes.

In addition to testing interventions, the announcement highlights a field-wide gap: clinicians and researchers often lack consistent ways to identify and characterize this "ambiguous" population that is experiencing harm or risk but does not fit neatly into OUD diagnoses. To address this, the opportunity calls for a resource center component that would help clinically identify this population and develop metrics that can be used broadly for more balanced assessment of opioid risks and harms. The emphasis on "balanced" assessment signals interest in measures that capture both risk and patient-centered benefits, supporting nuanced clinical decision-making rather than simplistic thresholds. This resource center is also expected to convene a panel of stakeholders and bioethicists, which suggests NIH wants ethical guardrails and broad perspectives guiding how patients are labeled, assessed, and managed, especially given the potential for unintended consequences like inappropriate tapering, undertreatment of pain, discrimination, or erosion of trust.

Administratively, this is a discretionary grant under NIH, with the Funding Opportunity Number RFA-DA-23-041. It sits within health-related federal assistance (with CFDA numbers listed as 93.213, 93.242, 93.279, 93.393, 93.865, 93.866). The original closing date shown is 2022-09-27, and the listed award ceiling is $750,000. The opportunity is structured as an R01, which typically supports multi-year, hypothesis-driven research projects with substantial scope, and here it explicitly requires a clinical trial, meaning applicants must be prepared to design and conduct a trial that prospectively evaluates the effect of an intervention on health-related outcomes.

Eligibility is broad and includes many common applicant types: 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 tribal governments; tribal organizations other than federally recognized governments; public housing authorities and Indian housing authorities; nonprofits with or without 501(c)(3) status (excluding institutions of higher education in those nonprofit categories as specified); for-profit organizations other than small businesses; and small businesses. The announcement also explicitly notes 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, and US territories or possessions. At the same time, it clearly restricts foreign participation: non-domestic (non-US) entities and foreign institutions are not eligible to apply, and non-domestic components of US organizations are not eligible. However, foreign components as defined by the NIH Grants Policy Statement are allowed, which typically means limited, well-justified parts of the work can occur outside the US under an eligible US applicant organization, subject to NIH policy and approval.

Overall, MIRHIQL is aimed at advancing evidence-based, ethically grounded, patient-informed approaches for a group that frequently falls into gray areas of clinical practice. It seeks interventions that reduce opioid-related harm while maintaining or improving quality of life, and it pairs that applied research aim with a call to build shared identification methods and metrics so the broader healthcare and research community can evaluate risk, benefit, and harm in a more consistent and clinically useful way.

• The National Institutes of Health in the education, health, income security and social services sector is offering a public funding opportunity titled "HEAL Initiative: Multilevel Interventions to Reduce Harm and Improve Quality of Life for Patients on Long Term Opioid Therapy (MIRHIQL) (R01 Clinical Trial Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.213, 93.242, 93.279, 93.393, 93.865, 93.866.
• This funding opportunity was created on 2022-07-11.
• Applicants must submit their applications by 2022-09-27. (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 $750,000.00 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.

Apply for RFA DA 23 041

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