Opportunity Information: Apply for HT942524DMRDPPTRCTA
The DoD Psychedelic Treatment Research Clinical Trial Award (DMRDP PTRCTA) is a U.S. Department of Defense funding opportunity that supports human clinical trials testing psychedelic-assisted treatments for two specific service-related health conditions: post-traumatic stress disorder (PTSD) and traumatic brain injury (TBI). Projects must focus on at least one of these covered conditions (PTSD, TBI, or both) and must evaluate at least one covered psychedelic intervention. The covered psychedelic substances named in the announcement are MDMA (3,4-methylenedioxy-methamphetamine), psilocybin, ibogaine, 5-MeO-DMT (5-methoxy-N,N-dimethyltryptamine), and certain plant-based alternative therapies. Studies can test these substances on their own or alongside other evidence-based treatments, with the overall aim of generating meaningful clinical evidence in military-relevant populations. The program is designed to support a range of trial stages, from small early proof-of-concept studies (such as pilot, first-in-human, or phase 0 work) that establish feasibility and inform later designs, all the way to larger trials intended to evaluate efficacy in appropriate patient populations.
A defining feature of this mechanism is that it is tied to Section 723 of the FY24 National Defense Authorization Act, which authorizes the Secretary of Defense to allow active-duty Service Members diagnosed with PTSD and/or TBI to participate in federally authorized clinical trials funded under this authority, even if the trial involves controlled substances and notwithstanding certain military legal restrictions that would otherwise apply. In practical terms, the opportunity is intended to remove participation barriers for active-duty personnel when the research is conducted under the proper clinical trial and regulatory framework, including FDA-related pathways where applicable.
The award is explicitly limited to clinical trials and cannot be used for animal studies or other preclinical research. The opportunity uses the federal regulatory definition of a clinical trial (45 CFR 46.102): a study where human subjects are prospectively assigned to an intervention (which can include placebo or control) to evaluate effects on biomedical or behavioral health outcomes. Trials that do not measure intervention safety, effectiveness, and/or efficacy outcomes are not considered responsive to this mechanism. Applicants also need to be prepared to move quickly: the clinical trial is expected to begin no later than six months after the award date, which puts a premium on having protocols, staffing, sourcing, site readiness, and regulatory strategy well developed at the time of application.
The required study population is another major constraint. The trial must include active-duty U.S. Service Members (and may include Reserve component members), and the program will not support study populations that are not Service Members. While the announcement notes that findings are expected to ultimately benefit Service Members, Veterans, and the public, Veterans are not the focus of this specific opportunity. Because enrollment feasibility is critical, applications are expected to clearly demonstrate access to an appropriate Service Member population and provide a realistic recruitment and accrual plan, including how the study will meet enrollment targets. The application should also lay out a strategy for including women and minorities in a way that matches the scientific objectives, and the program separately encourages attention to women’s health, including analysis of sex as a biological variable when relevant.
The DoD strongly emphasizes military relevance and collaboration. Competitive applications are expected to show strong connections to the military services and to benefit from partnerships across sectors, including collaborations among academia, industry, military organizations, the Department of Veterans Affairs, and other federal agencies. If the study relies on special resources, infrastructure, or databases, the application must describe confirmed access at submission and include a plan to maintain that access throughout the project. The program also flags that DoD-funded research involving military populations comes with unique rules, including restrictions and prohibitions around compensating DoD-affiliated personnel and additional considerations for certain subpopulations (for example, military families/children and U.S. Army Special Operations Command populations), so applicants are expected to understand and plan for those requirements.
From a compliance and operations standpoint, applications need to show that the intervention and materials are actually obtainable and sustainable for the full study period. Applicants must document the availability and access to the proposed psychedelic substance(s) and any other required materials. Because several covered substances are controlled, investigators must also pursue the appropriate Drug Enforcement Administration registrations and licenses for scheduled substances and document the status of those applications in the proposal materials. If the trial involves a drug not approved for the intended use in the country where the work will be conducted, an Investigational New Drug (IND) application (or equivalent) may be required under 21 CFR 312. The applicant is responsible for showing whether an IND is required; if it is required, it must be submitted by the start date of the period of performance for proposals recommended for funding. The program also expects the team and institution to be capable of meeting sponsor responsibilities when applicable, including FDA sponsor obligations described in 21 CFR 312 (Subpart D).
The mechanism puts heavy weight on trial readiness and credible clinical trial execution. Applicants must include preliminary data relevant to the proposed trial, and they must demonstrate the study team’s expertise in clinical trial conduct, controlled substance handling, statistical analysis, data management, and any FDA-related processes that apply. The proposal should identify study coordination capacity to manage IRB review, multi-site coordination (if applicable), regulatory steps with federal agencies, and participant accrual. A clearly articulated statistical analysis plan and power analysis are required so the proposed sample size is justified against the study’s objectives, along with a data management plan that protects data integrity. If a regulatory authority requires it, the trial must use a 21 CFR Part 11-compliant database and appropriate data standards.
Data sharing is treated as an expectation rather than an afterthought. Applicants are encouraged to use Common Data Elements (CDEs) suitable to the field, such as PhenX collections and the NINDS TBI CDEs, to improve harmonization and reuse. For PTSD-related human subjects data, applicants are encouraged to consider sharing through the National Institute of Mental Health Data Archive (NDA). For TBI, there is a specific requirement: if the project includes TBI-related clinical research data with at least 50 subjects funded by this program, the recipient must share the data through the DoD-NIH Federal Interagency TBI Research Informatics System (FITBIR), with annual uploads following FITBIR submission policies. The announcement also clarifies that CDMRP will not act as the government sponsor or signatory for data-sharing agreements, meaning awardees need to manage those arrangements themselves.
On funding and administration, awards will be made as grants. The total budget for an individual FY24 PTRCTA award is expected not to exceed $4.9 million in total costs for the entire period of performance. The agency anticipates roughly $9.8 million available to fund about two awards, with the possibility of additional awards if future appropriations allow. Awards using FY24 funds are expected to be made no later than September 30, 2025, and FY24 funds are anticipated to remain available for obligation and use through September 30, 2030 (subject to federal fiscal rules). Eligibility includes state governments, public and private institutions of higher education, and other eligible entities, including federal government organizations and research foundations partnering with federal organizations. The sponsoring agency listed is the Department of the Army (USAMRAA), and the posted closing date for the opportunity is October 4, 2024.Apply for HT942524DMRDPPTRCTA
- The Dept. of the Army -- USAMRAA in the science and technology and other research and development sector is offering a public funding opportunity titled "DoD Psychedelic Treatment Research Clinical Trial Award" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 12.420.
- This funding opportunity was created on 2024-07-30.
- Applicants must submit their applications by 2024-10-04. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The number of recipients for this funding is limited to 2 candidate(s).
- Eligible applicants include: State governments, Public and State controlled institutions of higher education, Private institutions of higher education, Others.
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FAQs: DoD Psychedelic Treatment Research Clinical Trial Award (DMRDP PTRCTA)
1) What is the DMRDP Psychedelic Treatment Research Clinical Trial Award (PTRCTA)?
The PTRCTA is a U.S. Department of Defense funding opportunity that supports human clinical trials evaluating psychedelic-assisted treatments for service-related health conditions. It is specifically aimed at generating meaningful clinical evidence in military-relevant populations.
2) Which health conditions does this award cover?
Projects must focus on at least one of two covered conditions: post-traumatic stress disorder (PTSD) and/or traumatic brain injury (TBI).
3) Are applicants allowed to study conditions other than PTSD and TBI?
No. The project must focus on PTSD, TBI, or both. The opportunity is framed around these covered conditions.
4) What psychedelic interventions are considered "covered" under this opportunity?
The announcement names the following covered psychedelic substances/interventions: MDMA (3,4-methylenedioxy-methamphetamine), psilocybin, ibogaine, 5-MeO-DMT (5-methoxy-N,N-dimethyltryptamine), and certain plant-based alternative therapies.
5) Can a study evaluate more than one covered psychedelic substance?
The opportunity requires that the project evaluate at least one covered psychedelic intervention. The announcement does not limit projects to only one substance, as long as the proposal remains focused, feasible, and clinically trial-ready.
6) Can the psychedelic intervention be tested alongside other treatments?
Yes. Studies may test a covered psychedelic intervention on its own or alongside other evidence-based treatments, with the overall aim of producing meaningful clinical evidence in military-relevant populations.
7) What types of clinical trials does the program support?
The program is designed to support a range of clinical trial stages, from small early proof-of-concept studies (including pilot, first-in-human, or phase 0 work) that establish feasibility and inform later designs, to larger trials intended to evaluate efficacy in appropriate patient populations.
8) Is this award limited to clinical trials only?
Yes. This mechanism is explicitly limited to clinical trials and cannot be used for animal studies or other preclinical research.
9) How does the opportunity define a clinical trial?
It uses the federal regulatory definition of a clinical trial in 45 CFR 46.102: a study where human subjects are prospectively assigned to an intervention (including placebo or control) to evaluate effects on biomedical or behavioral health outcomes.
10) Are trials without safety, effectiveness, or efficacy outcomes allowed?
No. Trials that do not measure intervention safety, effectiveness, and/or efficacy outcomes are not considered responsive to this mechanism.
11) What is the required study population for this award?
The trial must include active-duty U.S. Service Members (and may include Reserve component members). The program will not support study populations that are not Service Members.
12) Can Veterans be the main study population?
No. While the announcement notes findings are expected to ultimately benefit Service Members, Veterans, and the public, Veterans are not the focus of this specific opportunity, and the program will not support study populations that are not Service Members.
13) Are Reserve component members allowed to participate?
Yes. The announcement notes that the trial must include active-duty Service Members and may include Reserve component members.
14) Why does the award emphasize active-duty participation, including for controlled substances?
A defining feature of the mechanism is its link to Section 723 of the FY24 National Defense Authorization Act, which authorizes the Secretary of Defense to allow active-duty Service Members diagnosed with PTSD and/or TBI to participate in federally authorized clinical trials funded under this authority, even if controlled substances are involved and notwithstanding certain military legal restrictions that would otherwise apply.
15) When is the clinical trial expected to start after award?
The clinical trial is expected to begin no later than six months after the award date. This places strong emphasis on having protocols, staffing, sourcing, site readiness, and regulatory strategy well developed at the time of application.
16) What does the program expect regarding recruitment and enrollment feasibility?
Applications are expected to demonstrate access to an appropriate Service Member population and include a realistic recruitment and accrual plan, including how enrollment targets will be met.
17) Are there expectations for inclusion of women and minorities?
Yes. Applications should include a strategy for including women and minorities in a way that matches the scientific objectives. The program also encourages attention to women's health, including analysis of sex as a biological variable when relevant.
18) How important is military relevance and collaboration?
Military relevance is strongly emphasized. Competitive applications are expected to show strong connections to the military services and to benefit from partnerships across sectors (including academia, industry, military organizations, the Department of Veterans Affairs, and other federal agencies).
19) What if the project depends on special resources, infrastructure, or databases?
If special resources, infrastructure, or databases are needed, the application must describe confirmed access at the time of submission and include a plan to maintain that access throughout the project.
20) Are there unique DoD rules for research involving military populations?
Yes. The announcement flags unique rules for DoD-funded research with military populations, including restrictions and prohibitions around compensating DoD-affiliated personnel and additional considerations for certain subpopulations (such as military families/children and U.S. Army Special Operations Command populations). Applicants are expected to understand and plan for these requirements.
21) What must applicants show about access to the psychedelic substance(s) and other materials?
Applications need to demonstrate that the intervention and materials are obtainable and sustainable for the full study period. Applicants must document availability and access to the proposed psychedelic substance(s) and any other required materials.
22) What are the DEA requirements mentioned for controlled substances?
Because several covered substances are controlled, investigators must pursue appropriate Drug Enforcement Administration registrations and licenses for scheduled substances and document the status of those applications in the proposal materials.
23) When is an IND (Investigational New Drug) application required?
If the trial involves a drug not approved for the intended use in the country where the work will be conducted, an IND application (or equivalent) may be required under 21 CFR 312. The applicant is responsible for determining whether an IND is required.
24) If an IND is required, when must it be submitted?
If an IND is required, it must be submitted by the start date of the period of performance for proposals recommended for funding.
25) What FDA sponsor responsibilities may apply to awardees?
The program expects the team and institution to be capable of meeting sponsor responsibilities when applicable, including FDA sponsor obligations described in 21 CFR 312 (Subpart D).
26) Are applicants required to include preliminary data?
Yes. Applicants must include preliminary data relevant to the proposed trial.
27) What expertise does the study team need to demonstrate?
Applications must demonstrate expertise in clinical trial conduct, controlled substance handling, statistical analysis, data management, and any FDA-related processes that apply.
28) What operational and coordination capabilities are expected?
The proposal should identify study coordination capacity to manage IRB review, multi-site coordination (if applicable), regulatory steps with federal agencies, and participant accrual.
29) What are the requirements for statistical planning and sample size justification?
A clearly articulated statistical analysis plan and power analysis are required so the proposed sample size is justified against the study objectives.
30) What are the expectations for data management systems and standards?
A data management plan is required to protect data integrity. If a regulatory authority requires it, the trial must use a 21 CFR Part 11-compliant database and appropriate data standards.
31) Does the opportunity encourage using Common Data Elements (CDEs)?
Yes. Applicants are encouraged to use suitable Common Data Elements (CDEs), including examples such as PhenX collections and the NINDS TBI CDEs, to improve data harmonization and reuse.
32) What data sharing approach is encouraged for PTSD-related human subjects data?
For PTSD-related human subjects data, applicants are encouraged to consider sharing through the National Institute of Mental Health Data Archive (NDA).
33) What are the data sharing requirements for TBI-related data?
If the project includes TBI-related clinical research data with at least 50 subjects funded by this program, the recipient must share the data through the DoD-NIH Federal Interagency TBI Research Informatics System (FITBIR), with annual uploads following FITBIR submission policies.
34) Will CDMRP act as the government sponsor or signatory for data sharing agreements?
No. The announcement clarifies that CDMRP will not act as the government sponsor or signatory for data-sharing agreements, so awardees must manage those arrangements themselves.
35) What is the maximum expected budget per award?
The total budget for an individual FY24 PTRCTA award is expected not to exceed $4.9 million in total costs for the entire period of performance.
36) How many awards does the DoD expect to make, and what is the total anticipated funding?
The agency anticipates approximately $9.8 million available to fund about two awards, with the possibility of additional awards if future appropriations allow.
37) What type of funding instrument will be used?
Awards will be made as grants.
38) By when are awards using FY24 funds expected to be made?
Awards using FY24 funds are expected to be made no later than September 30, 2025.
39) How long are FY24 funds expected to remain available?
FY24 funds are anticipated to remain available for obligation and use through September 30, 2030, subject to federal fiscal rules.
40) Who is eligible to apply?
Eligibility includes state governments, public and private institutions of higher education, and other eligible entities, including federal government organizations and research foundations partnering with federal organizations.
41) Which DoD organization is listed as the sponsoring agency?
The sponsoring agency listed is the Department of the Army (USAMRAA).
42) What is the posted closing date for the opportunity?
The posted closing date is October 4, 2024.
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