HEAL Initiative: Sleep Predictors of Opioid-Use Disorder Treatment Outcomes Program (R01 Clinical Trial Optional) | RFA DA 23 059

Opportunity Information: Apply for RFA DA 23 059

The HEAL Initiative: Sleep Predictors of Opioid-Use Disorder Treatment Outcomes Program (R01 Clinical Trial Optional) is a National Institutes of Health (NIH) funding opportunity (RFA-DA-23-059) focused on how sleep and circadian rhythm problems intersect with opioid use disorder (OUD) and, importantly, how those sleep-related factors might help predict treatment response and relapse. The underlying premise is that sleep and circadian dysfunction are common in people with OUD and may be clinically useful signals for identifying who is at higher risk of poor outcomes during or after medication treatment for OUD. Within the broader HEAL (Helping to End Addiction Long-term) Initiative, this program emphasizes research that can move beyond describing sleep problems and toward identifying mechanisms and measurable predictors that could improve patient outcomes.

The program has two core scientific goals. First, it aims to uncover novel mechanisms that explain the bidirectional relationship between sleep/circadian rhythm disruption and OUD, meaning research should consider how opioid use and recovery can disturb sleep and circadian biology, and also how disrupted sleep and circadian timing might worsen craving, withdrawal, decision-making, mood regulation, pain sensitivity, or other factors that contribute to continued opioid use or relapse. Second, it seeks new insights into sleep- and/or circadian-based predictors of response to OUD medications and treatment outcomes. In practice, that points to studies that test whether specific sleep characteristics (for example, insomnia severity, sleep fragmentation, REM changes, sleep-disordered breathing, circadian misalignment, irregular sleep timing, or objective actigraphy-derived metrics) can predict clinically meaningful endpoints such as retention in treatment, medication adherence, opioid use recurrence, overdose risk, psychiatric symptom trajectories, or overall recovery stability.

The award mechanism is an R01 research project grant, with clinical trials marked as optional, which means applicants may propose studies that include a clinical trial component but are not required to do so. The opportunity sits in the health and education activity category and is associated with CFDA numbers 93.213, 93.273, and 93.279. The funding instrument type is a discretionary grant, and the listed award ceiling is $3,000,000. The posting indicates an original closing date of 2023-02-10 and a creation date of 2022-11-15, reflecting the specific cycle for that announcement.

Eligibility is broad and includes many common applicant types: state, county, and city or township 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 other than federally recognized tribal governments; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (excluding institutions of higher education in those nonprofit categories); for-profit organizations other than small businesses; small businesses; and other eligible entities. The announcement also highlights additional eligible applicants such as 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), eligible federal agencies, faith-based or community-based organizations, regional organizations, Indian/Native American tribal governments other than federally recognized tribes, and U.S. territories or possessions. At the same time, it clearly restricts foreign participation in certain ways: non-domestic (non-U.S.) entities (foreign institutions) are not eligible to apply, and non-domestic components of U.S. organizations are not eligible to apply. However, foreign components, as defined in the NIH Grants Policy Statement, are allowed, which typically means a U.S.-based applicant organization can include certain well-justified international elements or collaborations within NIH policy constraints, even though a foreign institution cannot be the direct applicant.

Overall, this opportunity is designed for research teams that can integrate sleep science, circadian biology, addiction medicine, and treatment outcomes research to identify actionable signals and mechanisms. The practical end goal is to improve understanding of why sleep and circadian disruption matter in OUD recovery and to develop evidence that sleep- and circadian-related measures could be used to anticipate treatment response, personalize care, and reduce relapse risk for people receiving medications for opioid use disorder.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "HEAL Initiative: Sleep Predictors of Opioid-Use Disorder Treatment Outcomes Program (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): 93.213, 93.273, 93.279.
• This funding opportunity was created on 2022-11-15.
• Applicants must submit their applications by 2023-02-10. (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 $3,000,000.00 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 23 059

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