Opportunity Information: Apply for RFA DA 24 034
The NIH grant opportunity "Mechanistic Research on Neuromodulation for Substance Use Disorders Treatment" (RFA-DA-24-034) supports clinical research that digs into how non-invasive brain stimulation (often shortened to NIBS) affects the brain and behavior in people with substance use disorders (SUDs). The central idea is not simply to test whether a stimulation approach reduces drug use, but to identify and validate specific brain targets and to measure the neurobiological, cognitive, and behavioral changes that happen after stimulation and that are thought to come before longer-term clinical outcomes like reduced craving or decreased substance use. In practice, the research NIH is looking for is mechanistic: studies designed to explain what is happening in the brain or body, how an intervention produces change, or what disease-related processes are being shifted by stimulation.
This NOFO is explicitly exploratory and developmental, meaning it is intended to fund early-stage work where the path is not fully proven yet. NIH signals that these projects can carry meaningful scientific risk, including a real chance that a particular approach will not work. The tradeoff is that if a study succeeds, it could produce a clear breakthrough, such as identifying a new stimulation target, a measurable brain-based marker of response, or a mechanistic pathway that later clinical trials can build on. The emphasis is on discovering the key signals and mechanisms that can guide future treatment development, not on running a large confirmatory effectiveness study.
The funding mechanism is a phased innovation award, using the R61/R33 structure. This format is designed to support a project in two linked stages. The first phase (R61) is the early, milestone-driven stage where investigators establish feasibility and demonstrate convincing mechanistic signals. The second phase (R33) is the expansion stage, typically used to build on the early results, refine the approach, and more fully validate targets, mechanisms, and outcome-relevant responses. Even though the specific milestone language is not included in the provided text, the R61/R33 model generally implies that progression from the first phase to the second depends on meeting predefined goals, so applicants should be prepared to lay out clear, measurable criteria for success.
A key requirement is that applications must meet the NIH definition of a clinical trial. NIH defines a clinical trial as a study in which one or more human subjects are prospectively assigned to one or more interventions (including placebo or other controls) to evaluate the effects on health-related biomedical or behavioral outcomes (referenced as NOT-OD-15-015). This matters because it signals that the work must involve active assignment to an intervention condition, not only observational measurement, and it must measure outcomes that NIH considers health-related. Because the NOFO also highlights "basic experimental studies with humans required," the intent is that the research be tightly controlled and experimentally oriented, while still being conducted in human participants and framed as a clinical trial under NIH policy.
From an administrative standpoint, the opportunity is a discretionary grant funded by the National Institutes of Health, listed under CFDA 93.847. The opportunity was created on September 29, 2023, and the original closing date is August 14, 2026. The listed award ceiling is $500,000, indicating the maximum amount expected per award under the information provided. The notice lists "ExpectedAwards:" but does not provide a number in the source text, so applicants would need to consult the full NOFO on the NIH/grants portal to confirm the expected award count and any additional budget or project period constraints.
Eligibility is broad and includes many common U.S. applicant types such as state, county, and local governments; public and private institutions of higher education; independent school districts; special district governments; and public housing authorities/Indian housing authorities. It also includes federally recognized Native American tribal governments and tribal organizations that are not federally recognized, as well as nonprofits with or without 501(c)(3) status, for-profit organizations (other than small businesses), and small businesses. The NOFO also calls out additional eligible groups 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), faith-based or community-based organizations, eligible federal agencies, U.S. territories or possessions, and even non-U.S. (foreign) organizations and regional organizations. This wide eligibility suggests NIH is open to a diverse range of applicants, including community-facing and global research entities, as long as the proposed work fits the scientific purpose and meets the clinical trial and mechanistic requirements.
Overall, this NOFO is aimed at accelerating the science of neuromodulation for substance use disorders by funding early, high-learning-value human studies that can pinpoint where and how NIBS should be applied, and what measurable intermediate responses indicate that stimulation is affecting the right biological and behavioral systems. The projects NIH wants are the kind that clarify mechanisms, sharpen targets, and produce validated markers that can later be tied to real-world clinical improvements such as reduced craving and reduced drug use.Apply for RFA DA 24 034
- The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Mechanistic Research on Neuromodulation for Substance Use Disorders Treatment (R61/R33 Basic Experimental Studies with Humans Required)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.847.
- This funding opportunity was created on 2023-09-29.
- Applicants must submit their applications by 2026-08-14. (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 $500,000.00 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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Frequently Asked Questions (FAQs)
What is the NIH opportunity RFA-DA-24-034 about?
RFA-DA-24-034, titled "Mechanistic Research on Neuromodulation for Substance Use Disorders Treatment," is an NIH grant opportunity supporting clinical research that examines how non-invasive brain stimulation (NIBS) changes the brain and behavior in people with substance use disorders (SUDs). The focus is on understanding mechanisms, not just showing that an intervention reduces substance use.
What does NIH mean by "mechanistic research" in this NOFO?
In this opportunity, mechanistic research refers to studies designed to explain how an intervention produces change. That includes identifying and validating specific brain targets and measuring neurobiological, cognitive, and behavioral changes after stimulation that are believed to occur before longer-term clinical outcomes (like reduced craving or decreased substance use).
Is this grant mainly for testing whether brain stimulation reduces drug use?
No. The central goal is not simply to test whether stimulation reduces drug use. The emphasis is on discovering and validating targets, mechanisms, and measurable intermediate responses (signals) that can guide later treatment development and future clinical trials.
What types of neuromodulation are in scope?
The opportunity centers on non-invasive brain stimulation (NIBS). The provided information does not list specific device types or modalities; it describes the broader category of non-invasive brain stimulation approaches used to affect brain and behavior in humans with SUDs.
Does the project have to be a clinical trial?
Yes. A key requirement is that applications must meet the NIH definition of a clinical trial.
How does NIH define a clinical trial for this funding opportunity?
NIH defines a clinical trial as a study in which one or more human subjects are prospectively assigned to one or more interventions (including placebo or other controls) to evaluate effects on health-related biomedical or behavioral outcomes (referenced as NOT-OD-15-015).
What does "prospectively assigned to one or more interventions" imply in practice?
It implies the study must actively assign human participants to an intervention condition (which can include placebo or other controls), rather than only observing people without assigning an intervention.
Why does NIH emphasize "basic experimental studies with humans required"?
Because the intent is for tightly controlled, experimentally oriented human research that still qualifies as a clinical trial under NIH policy. In other words, the studies should be designed to test specific mechanistic questions in humans under controlled conditions.
What kinds of outcomes is NIH looking for in these studies?
The NOFO emphasizes measuring neurobiological, cognitive, and behavioral changes that happen after stimulation and are thought to precede longer-term clinical outcomes. These intermediate responses may later be tied to clinical improvements such as reduced craving or decreased substance use.
What would count as a "breakthrough" result for this NOFO?
Examples described include identifying a new stimulation target, identifying a measurable brain-based marker of response, or clarifying a mechanistic pathway that later clinical trials can build on.
Is this NOFO intended for early-stage or late-stage research?
It is explicitly exploratory and developmental. NIH signals that the work can be early-stage and may carry meaningful scientific risk, including the possibility that a specific approach will not work.
How does NIH view scientific risk in this program?
This NOFO allows for meaningful scientific risk. The tradeoff NIH highlights is that even though approaches may fail, successful projects can yield high-impact mechanistic insights, validated targets, or markers that enable later treatment development.
What funding mechanism does this opportunity use?
The award uses a phased innovation structure: R61/R33.
What is the R61/R33 structure, and how does it work?
The R61 is the early, milestone-driven phase focused on establishing feasibility and demonstrating convincing mechanistic signals. The R33 is the expansion phase used to build on early results, refine the approach, and more fully validate targets, mechanisms, and outcome-relevant responses.
Does progression from R61 to R33 happen automatically?
No. While specific milestone language is not included in the provided information, the R61/R33 model generally implies that moving from R61 to R33 depends on meeting predefined goals. Applicants should be prepared to propose clear, measurable success criteria.
What is the maximum award amount mentioned in the provided information?
The listed award ceiling is $500,000, which indicates the maximum amount expected per award under the provided information.
How many awards does NIH expect to make under this NOFO?
The notice lists "ExpectedAwards:" but does not provide a number in the provided text. To confirm expected award count, applicants would need to consult the full NOFO posting on NIH/grants portals.
Which NIH program or agency is funding this opportunity?
This is a discretionary grant funded by the National Institutes of Health (NIH).
What is the CFDA number for this grant opportunity?
The opportunity is listed under CFDA 93.847.
When was this opportunity created, and what is the closing date?
The opportunity was created on September 29, 2023, and the original closing date listed is August 14, 2026.
Who is eligible to apply?
Eligibility is broad. The provided information lists many eligible applicant types, including state, county, and local governments; public and private institutions of higher education; independent school districts; special district governments; public housing authorities/Indian housing authorities; federally recognized Native American tribal governments; tribal organizations that are not federally recognized; nonprofits (with or without 501(c)(3) status); for-profit organizations (other than small businesses); small businesses; and additional groups such as various minority-serving institutions, faith-based or community-based organizations, eligible federal agencies, U.S. territories or possessions, and non-U.S. (foreign) and regional organizations.
Are small businesses eligible?
Yes. Small businesses are listed as eligible in the provided information.
Are for-profit organizations eligible?
Yes. For-profit organizations (other than small businesses) are included as eligible applicant types in the provided information.
Are nonprofits required to have 501(c)(3) status?
No. The eligibility description includes nonprofits with or without 501(c)(3) status.
Are tribal governments and tribal organizations eligible?
Yes. The eligibility list includes federally recognized Native American tribal governments and tribal organizations that are not federally recognized.
Are minority-serving institutions specifically encouraged or included?
The provided eligibility list explicitly includes Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), and Tribally Controlled Colleges and Universities (TCCUs).
Are faith-based or community-based organizations eligible?
Yes. Faith-based or community-based organizations are specifically called out as eligible in the provided information.
Can non-U.S. (foreign) organizations apply?
Yes. The eligibility list includes non-U.S. (foreign) organizations and regional organizations.
What is the overall purpose or long-term impact NIH is aiming for?
The overall aim is to accelerate the science of neuromodulation for SUDs by funding early, high-learning-value human studies that pinpoint where and how NIBS should be applied and what measurable intermediate responses indicate that stimulation is affecting relevant biological and behavioral systems. These outputs are intended to inform later treatment development and future clinical trials tied to clinical improvements.
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