DoD Psychedelic Treatment Research Clinical Trial Award | HT942524DMRDPPTRCTA

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.

• 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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