HEAL Initiative: Sleep and Circadian-Dependent Mechanisms Contributing to Opiate Use Disorder (OUD) and Response to Medication Assisted Treatment (MAT) (U01 Clinical Trial Optional) | RFA HL 19 029

Opportunity Information: Apply for RFA HL 19 029

The HEAL Initiative funding opportunity "Sleep and Circadian-Dependent Mechanisms Contributing to Opiate Use Disorder (OUD) and Response to Medication Assisted Treatment (MAT)" (RFA-HL-19-029) is an NIH cooperative agreement (U01) that supports clinical research focused on how sleep and circadian biology shape key aspects of opioid use disorder. The central aim is to generate mechanistic, clinically grounded evidence about how sleep disruption and circadian misalignment contribute to (1) vulnerability and risk for developing OUD, (2) the underlying biology and clinical expression of opioid withdrawal, and (3) how well patients respond to medication-assisted treatment (MAT), including the biological reasons some individuals respond differently than others. While clinical trials are optional under this FOA, the program is clearly oriented toward studies that explain "how" and "why" through rigorous mechanistic designs rather than simply testing whether an intervention works.

This FOA is designed for studies that leverage modern advances in sleep and circadian science to clarify the directionality and interaction between sleep/circadian problems and OUD. In practical terms, NIH is looking for projects that can disentangle whether sleep and circadian disruptions are risk factors that precede opioid misuse, consequences of opioid exposure and withdrawal, drivers of relapse risk, modifiers of craving and mood, or determinants of treatment adherence and outcomes. The expectation is that applicants will use strong clinical phenotyping and objective or well-validated measures (for example, sleep architecture, circadian phase markers, rest-activity rhythms, timing of drug use and dosing, withdrawal symptom trajectories, and clinically relevant neurobiological or pharmacologic measures) to connect sleep and circadian mechanisms to OUD pathobiology and MAT response.

A major emphasis is on team science. Competitive applications are expected to come from multidisciplinary, multi-investigator groups that can cover the necessary clinical and mechanistic expertise, such as clinical OUD research and patient recruitment, sleep medicine and circadian rhythm biology, neurobiology relevant to addiction and reward, and neuropharmacology relevant to MAT. The goal is not just to observe correlations but to build a coherent mechanistic narrative that explains clinical outcomes in OUD through the lens of sleep and circadian systems.

The announcement also draws a firm boundary around what is and is not responsive. It is only open to research that directly addresses OUD-relevant mechanisms and pathobiology. Proposals that mainly evaluate the efficacy of one or more interventions, without embedding that work in a rigorous mechanistic framework, are discouraged. In other words, an intervention study can fit only if it is designed primarily to test mechanistic hypotheses about sleep/circadian-dependent pathways in OUD or MAT response, rather than serving as a straightforward clinical efficacy trial.

Administratively, this opportunity sits within NIH and is part of the HEAL (Helping to End Addiction Long-term) Initiative, reflecting a broader federal priority to improve prevention and treatment of opioid misuse through better biological understanding. The funding instrument is a cooperative agreement, which generally indicates substantial NIH scientific or programmatic involvement during the project, such as coordination, milestone tracking, and collaborative steering typical of U01 mechanisms. The posted award ceiling is $750,000 (as provided in the source), and the original application closing date listed is 2019-02-27. The funding activity category is listed under education and health, and the CFDA numbers associated with the opportunity include 93.233, 93.279, and several 93.83x entries (93.837 through 93.840), reflecting NIH program alignment.

Eligibility is broad across U.S.-based organizations and government entities. 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 tribal governments; tribal organizations (including those 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 organizations as allowed. The FOA explicitly calls out additional eligible institution types such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISISs, Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, regional organizations, eligible agencies of the federal government, and U.S. territories or possessions.

At the same time, it places strict limits on foreign involvement. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply, non-domestic components of U.S. organizations are not eligible, and foreign components as defined by the NIH Grants Policy Statement are not allowed. This means the research team, performance sites, and formal project components must remain within allowable U.S.-based structures.

Overall, the opportunity is aimed at moving beyond surface-level associations between sleep problems and opioid misuse by funding clinical studies that can map sleep and circadian mechanisms onto withdrawal biology and MAT response. The intended payoff is actionable mechanistic insight that can inform better-targeted prevention approaches, improve individualized treatment strategies, and ultimately strengthen outcomes for people with OUD by accounting for sleep and circadian influences that may be driving risk and treatment variability.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "HEAL Initiative: Sleep and Circadian-Dependent Mechanisms Contributing to Opiate Use Disorder (OUD) and Response to Medication Assisted Treatment (MAT) (U01 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.233, 93.279, 93.837, 93.838, 93.839, 93.840.
• This funding opportunity was created on 2018-12-10.
• Applicants must submit their applications by 2019-02-27. (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 HL 19 029

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