Optimizing Treatment Strategies for Adult Attention-Deficit Hyperactivity Disorder (ADHD) (R01 Clinical Trial Required) | RFA MH 26 195

Opportunity Information: Apply for RFA MH 26 195

The National Institutes of Health (NIH) is soliciting applications under the grant opportunity "Optimizing Treatment Strategies for Adult Attention-Deficit Hyperactivity Disorder (ADHD)" (Funding Opportunity Number RFA-MH-26-195). This is an R01 mechanism and it requires a clinical trial, meaning applicants are expected to propose and conduct a rigorously designed human subjects study that prospectively evaluates one or more interventions for adult ADHD. The overall purpose is to strengthen the evidence base for how best to treat ADHD in adults, a population where diagnostic recognition has grown more recently and where practical, clinical decision-making still often relies on limited comparative data and real-world sequencing guidance.

A central theme of the announcement is the need to look beyond stimulant-only approaches. Stimulant medications are acknowledged for their rapid onset and long history of effectiveness, but NIH highlights several reasons why reliance on stimulants alone is not always ideal: adverse effects and tolerability concerns, risks of dependence, misuse, and diversion, and the very practical problem of recent medication shortages. Because of these limitations, the NOFO encourages research that can guide clinicians and patients toward evidence-based complementary, alternative, or adjunctive strategies when stimulants are not sufficient, not tolerated, or simply not preferred.

The projects NIH wants to support are clinical trials that test non-stimulant medications, psychosocial interventions, and device-based approaches. Importantly, the NOFO is not limited to single-modality trials. It explicitly encourages studies that evaluate these approaches sequentially or in combination, reflecting the way treatment is often adjusted in real clinical care. Proposed trials can focus on augmenting stimulants (for example, adding another modality when stimulant response is partial), replacing stimulants (when stimulants are ineffective, contraindicated, or undesirable), and evaluating strategies across both acute and post-acute phases of care. In addition to treating established adult ADHD, the NOFO also allows a prevention-oriented angle: trials aimed at preventing or reducing the transition or persistence of ADHD symptoms from adolescence into adulthood, which opens the door to longer-term, developmental trajectories and early-intervention strategies, as long as the work remains aligned with the adult ADHD optimization focus.

Eligibility is broad and includes many common applicant categories such as state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; nonprofit organizations (with or without 501(c)(3) status); for-profit organizations (other than small businesses); small businesses; and federally recognized Native American tribal governments. The NOFO also notes additional eligible applicant types, including eligible federal agencies, faith-based or community-based organizations, and tribal organizations or tribal governments that are not federally recognized. Regional organizations and U.S. territories or possessions may apply as well.

The opportunity includes international eligibility in a limited form. Non-U.S. (foreign) organizations are eligible to apply, and non-U.S. components of U.S. organizations are also eligible. However, "foreign components" as defined by the NIH Grants Policy Statement are not allowed, which is a technical but important distinction that can affect how international collaborations are structured, where work is performed, and what qualifies as a component of the project. Applicants contemplating any work outside the United States would need to pay close attention to NIH policy definitions and structure the project accordingly.

Key administrative details provided in the source information include that the sponsoring agency is NIH, the opportunity category is discretionary, the funding instrument is a grant, and the activity category is health (CFDA 93.242). The original closing date listed is 2025-11-25, and the opportunity was created on 2025-09-17. The award ceiling and expected number of awards are not specified in the provided excerpt, which typically means applicants would need to consult the full NOFO text and any linked budget guidance to understand typical NIH R01 budget expectations, constraints (if any), and institute-specific considerations. Overall, this announcement is geared toward generating practical, actionable evidence about how to deploy non-stimulant, psychosocial, and device-based interventions in adult ADHD care, including how to combine or sequence treatments in ways that reflect real clinical challenges and patient needs.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Optimizing Treatment Strategies for Adult Attention-Deficit Hyperactivity Disorder (ADHD) (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): 93.242.
• This funding opportunity was created on 2025-09-17.
• Applicants must submit their applications by 2025-11-25. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• 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 MH 26 195

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