Opportunity Information: Apply for RFA DA 24 029
The National Institutes of Health (NIH) funding opportunity announcement titled "Advancing Psychedelics Research for Treating Addiction (R61/R33 Basic Experimental Study with Humans Required)" (Funding Opportunity Number RFA-DA-24-029) supports multidisciplinary research aimed at closing key scientific gaps about psychedelic compounds as potential treatments for substance use disorders (SUD). The central emphasis is on moving beyond general therapeutic promise and generating rigorous, mechanism-focused evidence about how psychedelics work in humans, including how they engage biological targets, what their downstream effects are, and how those effects relate to clinically meaningful outcomes in addiction. In practical terms, the FOA is designed to stimulate a coordinated pipeline of translational research that links basic human experimental findings to early clinical testing, with careful attention to the kinds of data needed to responsibly advance psychedelics as neurotherapeutics for addiction.
A major theme of this opportunity is systematic evaluation of mechanism of action and drug-target engagement in the context of addiction biology and behavior. Supported projects are expected to sharpen understanding of how psychedelic administration alters neurobiological systems and processes relevant to SUD, and how those changes map onto craving, withdrawal, reinforcement learning, stress responsivity, compulsive use, relapse risk, or other addiction-relevant domains. The FOA also explicitly calls for translational elements that help make findings actionable for later-stage development, including characterization of safety considerations, pharmacokinetics and pharmacodynamics (PK/PD), and evidence of efficacy signals. Rather than treating these as separate checkboxes, the announcement frames them as interconnected: PK/PD helps interpret exposure-response relationships, target engagement clarifies whether the hypothesized mechanism is being activated, and safety and efficacy data together inform whether the approach is viable for further clinical advancement in SUD populations.
The mechanism used is the R61/R33 phased innovation award, which generally reflects a milestone-driven structure where an initial phase supports early, high-impact development and proof-of-concept work (R61), followed by a subsequent phase (R33) that expands or confirms findings once predefined milestones are met. In this FOA, the requirement for a "Basic Experimental Study with Humans" signals that proposed work must include human participants and incorporate experimental manipulations or interventions intended to illuminate fundamental mechanisms or causal pathways, not solely observational or retrospective analyses. This aligns with the announcement's goal of generating direct, interpretable evidence about how psychedelics act in humans and how that action could translate into improved outcomes for addiction.
From an administrative and eligibility standpoint, the opportunity is categorized as a discretionary grant under NIH, within the Education and Health activity category, and is associated with CFDA number 93.279. The application window listed includes an original closing date of 2023-11-02, and the source data lists an award ceiling of $700,000. The eligible applicant pool is broad and includes state, county, city/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 tribal governments; public housing authorities/Indian housing authorities; nonprofits (both 501(c)(3) and non-501(c)(3), excluding institutions of higher education where specified); for-profit organizations other than small businesses; small businesses; and additional "other" categories. The FOA also highlights expanded eligibility and encouragement for a range of institution types and organizations, 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), faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and even non-domestic (non-U.S.) entities (foreign organizations). Taken together, that eligibility language suggests NIH is aiming to broaden participation and encourage diverse institutional leadership and community connections in this area of research.
Overall, this FOA is focused on building a stronger, more mechanistic evidence base for psychedelic-assisted or psychedelic-based interventions for addiction, with the expectation that funded projects will clarify how these compounds interact with human biology and behavior, establish translational markers of engagement and response, and produce carefully measured safety, PK/PD, and early efficacy data that can inform next-step clinical development for SUD.Apply for RFA DA 24 029
- The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Advancing Psychedelics Research for Treating Addiction (R61/R33 Basic Experimental Study with Humans Required)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.279.
- This funding opportunity was created on 2023-05-16.
- Applicants must submit their applications by 2023-11-02. (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 $700,000.00 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 name of this NIH funding opportunity?
The funding opportunity announcement (FOA) is titled "Advancing Psychedelics Research for Treating Addiction (R61/R33 Basic Experimental Study with Humans Required)."
What is the Funding Opportunity Number (FON)?
The Funding Opportunity Number is RFA-DA-24-029.
What is the main goal of this FOA?
The main goal is to support multidisciplinary research that closes key scientific gaps about psychedelic compounds as potential treatments for substance use disorders (SUD). The emphasis is on generating rigorous, mechanism-focused evidence in humans, including drug-target engagement, downstream biological and behavioral effects, and how those effects relate to clinically meaningful addiction outcomes.
What types of research does NIH want to see in this program?
NIH is looking for a coordinated, translational pipeline that links basic experimental findings in humans to early clinical testing. Projects are expected to produce interpretable evidence about how psychedelics work in humans and to generate data that can responsibly support further development of psychedelics as neurotherapeutics for addiction.
Is this FOA focused on general therapeutic promise or on mechanisms?
This FOA is explicitly focused on moving beyond general therapeutic promise. The central priority is mechanism-focused research, including understanding biological target engagement, downstream effects, and how these relate to addiction-relevant outcomes.
Does the FOA require human participants?
Yes. The FOA includes the requirement "Basic Experimental Study with Humans Required," which means the proposed work must include human participants.
What does "Basic Experimental Study with Humans" mean in this FOA?
In this FOA, it signals that the research must involve human participants and include experimental manipulations or interventions designed to illuminate fundamental mechanisms or causal pathways. It is not limited to observational or retrospective analyses.
What specific scientific questions is the FOA trying to address?
The FOA aims to clarify how psychedelic administration alters neurobiological systems and processes relevant to SUD, and how those changes map onto addiction-relevant domains such as craving, withdrawal, reinforcement learning, stress responsivity, compulsive use, relapse risk, and other SUD-related behaviors and outcomes.
What is meant by "mechanism of action" in the context of this opportunity?
Mechanism of action here refers to how psychedelic compounds engage biological targets in humans, what downstream neurobiological and behavioral effects follow, and how those effects connect to clinically meaningful addiction outcomes.
What is "drug-target engagement," and why is it important in this FOA?
Drug-target engagement refers to evidence that the psychedelic compound is interacting with the hypothesized biological target(s) in humans. The FOA emphasizes this because it strengthens interpretability: it helps confirm whether the proposed mechanism is actually being activated and supports translating findings into later-stage development.
Are translational elements expected, and what do they include?
Yes. The FOA explicitly calls for translational elements that make results actionable for later-stage development. These include safety considerations, pharmacokinetics and pharmacodynamics (PK/PD), and evidence of efficacy signals, framed as interconnected components rather than separate checkboxes.
Why does the FOA emphasize PK/PD?
PK/PD data help interpret exposure-response relationships. Within this FOA, PK/PD is positioned as a key piece of the overall evidence package that supports mechanism interpretation, target engagement claims, and translation to early clinical testing.
How does NIH describe the relationship between PK/PD, target engagement, safety, and efficacy in this FOA?
The FOA frames them as interconnected: PK/PD supports exposure-response interpretation, target engagement helps show the hypothesized mechanism is being activated, and safety and efficacy data together inform whether the approach is viable for further clinical advancement in SUD populations.
What grant mechanism is used for this opportunity?
This opportunity uses the NIH R61/R33 phased innovation award mechanism.
What is the basic structure of the R61/R33 phased innovation award?
It is milestone-driven. The initial R61 phase supports early, high-impact development and proof-of-concept work. The subsequent R33 phase expands or confirms findings once predefined milestones are met.
What kinds of outcomes is the FOA interested in relating to psychedelic effects?
The FOA highlights addiction-relevant outcomes and domains such as craving, withdrawal, reinforcement learning, stress responsivity, compulsive use, relapse risk, and other clinically meaningful SUD-related endpoints.
What is the activity category and type of award?
The opportunity is described as a discretionary grant under NIH and is associated with the Education and Health activity category.
What CFDA number is associated with this opportunity?
The CFDA number listed is 93.279.
What is the listed application closing date?
The application window information provided includes an original closing date of 2023-11-02.
What is the award ceiling listed in the source data?
The source data lists an award ceiling of $700,000.
Who is eligible to apply?
The eligible applicant pool is broad. It includes state, county, city/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 tribal governments; public housing authorities/Indian housing authorities; nonprofits (501(c)(3) and non-501(c)(3), excluding institutions of higher education where specified); for-profit organizations other than small businesses; small businesses; and other categories.
Does the FOA encourage applications from specific institution types?
Yes. The FOA highlights expanded eligibility and encouragement for a wide range of organizations and institution types, including Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, HBCUs, TCCUs, faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions.
Are non-U.S. (foreign) organizations eligible to apply?
Yes. The eligibility language included in the provided information indicates that non-domestic (non-U.S.) entities (foreign organizations) are included.
Is this FOA limited to academic institutions?
No. The eligible applicant pool includes many types of organizations beyond universities, including government entities, nonprofits, for-profits, small businesses, tribal governments and organizations, public housing authorities, and foreign organizations.
Is this program specifically about treating addiction?
Yes. The FOA focuses on psychedelics research as potential treatments for substance use disorders (SUD) and on understanding how psychedelic-related biological and behavioral effects connect to addiction-relevant outcomes.
What does NIH mean by building a "coordinated pipeline" in this FOA?
Based on the description provided, it refers to a translational progression that connects basic experimental human studies (to establish mechanisms and target engagement) with early clinical testing, while generating the kinds of safety, PK/PD, and early efficacy data needed to support responsible next-step development.
What is the overall expected value of funded projects under this FOA?
Funded projects are expected to strengthen the mechanistic evidence base for psychedelic-assisted or psychedelic-based interventions for addiction by clarifying how compounds interact with human biology and behavior, establishing translational markers of engagement and response, and producing carefully measured safety, PK/PD, and early efficacy signals to inform next-step clinical development for SUD.
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