Mechanistic Studies to Investigate the Interrelationship Between Sleep and/or Circadian Rhythms and Substance Use Disorders (R01 Clinical Trials Not Allowed) | RFA DA 24 020

Opportunity Information: Apply for RFA DA 24 020

The NIH funding opportunity RFA-DA-24-020, titled "Mechanistic Studies to Investigate the Interrelationship Between Sleep and/or Circadian Rhythms and Substance Use Disorders (R01 Clinical Trials Not Allowed)," is a discretionary grant program designed to support basic science, experimental research on how sleep and circadian biology intersect with substance use disorders (SUDs). The central aim is to move beyond simple associations and instead generate mechanistic evidence about the underlying biological, neurobehavioral, and physiological processes that connect disrupted sleep or circadian rhythms with the development, maintenance, or progression of SUDs, and conversely, how substance use and addiction-related processes disrupt sleep and circadian function. By focusing on mechanisms, the program is positioned to produce foundational knowledge that can ultimately inform prevention strategies, risk management approaches, and the identification of novel intervention or therapeutic targets, even though clinical trials are explicitly not allowed under this announcement.

This NOFO uses the NIH R01 research project grant mechanism, which typically supports hypothesis-driven research programs with clearly defined aims, rigorous methods, and a strong rationale for how the work will advance scientific understanding in the field. The announcement emphasizes basic science experimental studies, meaning applications are expected to use designs and methods that can test causal pathways and explain "how" and "why" links occur between sleep/circadian disruption and substance-related behaviors or addiction phenotypes. While the results may have downstream clinical relevance, the work itself should be mechanistic in nature, for example by interrogating neurobiological circuits, signaling pathways, molecular and genetic contributions, sleep architecture changes, circadian timing mechanisms, or experimentally induced perturbations that reveal cause-and-effect relationships. Because the opportunity is labeled "Clinical Trials Not Allowed," proposed studies should not be structured as clinical trials evaluating the efficacy or effectiveness of an intervention in humans, although observational human studies or laboratory-based human mechanistic studies may be allowable if they do not meet NIH's definition of a clinical trial and are clearly focused on mechanism rather than intervention outcomes.

The scientific focus is on the bidirectional relationship between sleep/circadian rhythms and SUDs. On one side, the opportunity is interested in how sleep loss, insomnia, circadian misalignment, or altered circadian timing may increase vulnerability to substance initiation, escalation, relapse risk, craving, or impaired decision-making. On the other side, it supports research on how substances of misuse, withdrawal states, chronic exposure, or neuroadaptations associated with addiction can alter sleep continuity, sleep stages, circadian rhythmicity, and related regulatory systems. Mechanistic work in this area can have practical implications, such as improving approaches to identifying individuals at higher risk for developing SUDs based on sleep/circadian markers, clarifying biological targets for pharmacologic or behavioral strategies in the future, and informing timing-based or rhythm-based prevention concepts, even if the funded project itself is not testing a treatment.

In terms of administrative details, this is a federal discretionary grant offered by the National Institutes of Health under the CFDA listing 93.279. The original closing date listed for this opportunity was 2023-11-13, and the creation date is 2023-04-18. The funding instrument type is a grant, and the funding activity category is listed as education and health, reflecting the public health and biomedical research nature of NIH awards. The award ceiling shown is $300,000, indicating an upper limit presented in the source data for funding under this announcement.

Eligibility is broad and includes many organization types that commonly apply for NIH research funding. Eligible applicants include state, county, city or township, and 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 (excluding institutions of higher education where applicable); for-profit organizations other than small businesses; and small businesses. The announcement also explicitly highlights additional eligible applicants, 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), eligible federal agencies, faith-based or community-based organizations, regional organizations, U.S. territories or possessions, Indian/Native American Tribal Governments other than federally recognized entities, and non-domestic (non-U.S.) entities such as foreign organizations. This breadth signals an intent to encourage participation across diverse institutional settings and communities, including organizations that may be uniquely positioned to study sleep, circadian rhythms, and substance use risk in different populations or contexts.

Overall, the opportunity is best understood as a targeted NIH R01 mechanism for mechanistic, basic science research that explains the biological and behavioral links between sleep/circadian systems and substance use disorders, with the expectation that clarifying these links will lay groundwork for future prevention and therapeutic advances. Applicants would typically be expected to articulate a compelling mechanistic question, justify the experimental approach, define measurable sleep/circadian and substance-related outcomes relevant to mechanism, and ensure the proposed research stays clearly outside the bounds of a clinical trial while still producing insights that matter for addiction science and sleep/circadian biology.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Mechanistic Studies to Investigate the Interrelationship Between Sleep and/or Circadian Rhythms and Substance Use Disorders (R01 Clinical Trials Not Allowed)" 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 2023-04-18.
• Applicants must submit their applications by 2023-11-13. (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 $300,000.00 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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