Optimizing Treatment Strategies for Adult Attention-Deficit Hyperactivity Disorder (ADHD) (R01 Clinical Trial Required)

The U.S. Department of Health and Human Services, through the National Institutes of Health and specifically the National Institute of Mental Health (NIMH), has released a funding opportunity titled “Optimizing Treatment Strategies for Adult Attention-Deficit Hyperactivity Disorder (ADHD) (R01 Clinical Trial Required).” The initiative addresses the growing recognition that ADHD persists into adulthood, affecting an estimated 4% of adults in the United States, or more than 15 million people. Traditional stimulant medications remain the mainstay of treatment but present challenges, including dependency risks, supply shortages, and tolerability issues. This funding opportunity supports research to develop evidence-based nonstimulant alternatives, including pharmacological, psychosocial, and device-based interventions. The intent is to provide effective, scalable treatments for adults when stimulant monotherapy is insufficient, undesirable, or unavailable. The purpose of this Notice of Funding Opportunity is to encourage clinical trials that adapt, optimize, and test empirically supported non-stimulant treatments, either alone or in combination with stimulants, in adult populations. Research may include nonstimulant medications such as atomoxetine or viloxazine, device-based interventions like trigeminal nerve stimulation, or psychosocial approaches such as cognitive-behavioral therapy. Applications must meet full DSM-5-TR criteria for adult ADHD participants, ensure confirmation of childhood onset, and may include comorbid conditions provided they are not the primary treatment focus. Proposals must align with the NIMH experimental therapeutics framework, including an analysis of intervention mechanisms, measurable targets, and validated outcome tools. Studies must also take place in real-world community practice settings rather than academic research laboratories. The funding instrument will be a research project grant under the R01 activity code. Clinical trials are required for all applications. The NIMH intends to commit $3,000,000 in FY 2026 to fund up to four awards, with no stated maximum budget per project but an expected alignment with proposed scope. The maximum project period is five years, though shorter projects are encouraged if feasible. All NIH grants policies apply. No cost sharing is required. Matching funds are not requested. Applications must comply with NIMH’s requirements for human subjects research, safety monitoring, and data management, including the expectation to share study data via the NIMH Data Archive. The eligibility criteria for this funding opportunity are broad. Applications are accepted from U.S. and non-U.S. entities, including higher education institutions, nonprofits, for-profit organizations, local and state governments, tribal entities, school districts, public housing authorities, faith-based organizations, and independent or regional organizations. Small businesses and larger for-profit organizations are eligible. However, NIH will no longer issue awards involving foreign subawards or subcontracts; foreign entities may apply directly, but subawards to international collaborators are not permitted. All applicant organizations must complete required registrations in SAM.gov, Grants.gov, and eRA Commons prior to submission. Principal Investigators must hold an eRA Commons account and demonstrate relevant expertise and capacity. Applications will be reviewed for significance, innovation, rigor, and feasibility, with a strong emphasis on real-world applicability, scalability, and the inclusion of diverse populations and under-resourced settings. Reviewers will consider the proposed mechanisms of action, fidelity of intervention delivery, inclusion of suicide-related outcomes, and the use of validated measurement tools. Plans must incorporate stakeholder input and strategies to reduce disparities in mental health outcomes. Applicants are required to provide statistical analysis plans, power calculations, and monitoring protocols. The key dates for this opportunity are as follows: the notice was posted on September 17, 2025; the application submission window opens on October 25, 2025; and the final application deadline is November 25, 2025, at 5:00 PM local time of the applicant organization. Scientific merit reviews are scheduled for March 2026, advisory council review in May 2026, and the earliest project start date is July 2026. The funding opportunity expires on November 26, 2025. Letters of intent are not required for this opportunity. Applications must be submitted through NIH ASSIST, Grants.gov Workspace, or institutional system-to-system platforms, with tracking available via eRA Commons. Applicants seeking further clarification may contact Dr. Matthew V. Rudorfer, the NIMH scientific and research contact, at mrudorfe@mail.nih.gov or 301-443-1111. Financial questions can be directed to Christine Clarkson at christine.clarkson@nih.gov or 301-443-8811. Peer review questions may be addressed to the Center for Scientific Review at NOFOReviewContact@csr.nih.gov. General inquiries can be directed to GrantsInfo@nih.gov or 301-480-7075, or to the eRA Service Desk and Grants.gov Customer Support as appropriate. Applicants are encouraged to initiate registrations and application preparation early to avoid delays and ensure compliance.