DoD Psychedelic Treatment Research Clinical Trial Award

The intent of the DMRDP PTRCTA is to support clinical trials with eligible U.S. Service Members to evaluate treatments for post-traumatic stress disorder (PTSD) and/or traumatic brain injury (TBI) involving the use of covered psychedelic substances. Applicants must select at least one of the two covered conditions (PTSD, TBI, or both) and one or more of the covered psychedelic substances listed below. Treatment may involve the use of covered psychedelic substances alone or in conjunction with other evidence-based treatments. Proposed projects may range from small proof-of-concept trials (e.g., pilot, first-in-human, phase 0) to demonstrate the feasibility or inform the design of more advanced trials, through large-scale trials to determine efficacy in relevant patient populations.Covered psychedelic substances include: 3,4-Methylenedioxy-methamphetamine (commonly known as MDMA) psilocybin ibogaine 5-Methoxy-N,N-dimethyltryptamine (commonly known as 5-MeO-DMT) plant-based alternative therapiesPer Section 723 of the National Defense Authorization Act for Fiscal Year 2024, the Secretary of Defense may authorize any member of the Armed Forces serving on active duty who is diagnosed with a covered condition (PTSD or TBI) to participate in a clinical trial that is conducted using funding awarded under this section and is authorized pursuant to section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), without regard to (1) whether the clinical trial involves a substance included in the schedule under section 202 of the Controlled Substances Act (21 U.S.C. 812); or (2) section 912a of title 10, United States Code (article 112a of the Uniform Code of Military Justice).Military Relevance and Military Service Collaboration: Applications from investigators within the military services and applications involving multidisciplinary collaborations among academia, industry, the military services, the U.S. Department of Veterans Affairs (VA), and other federal government agencies are highly encouraged. These relationships can leverage knowledge, infrastructure, and access to unique clinical populations that the collaborators bring to the research effort, ultimately advancing research that is of significance to Service Members, Veterans, and/or their Families. If the proposed research relies on access to unique resources or databases, the application must describe the access at the time of submission and include a plan for maintaining access as needed throughout the proposed research. A list of websites that may be useful in identifying potential opportunities for collaboration can be found in Appendix II.Conducting DOD-Funded Human Research with Military Populations: There are unique requirements and prohibitions for compensating DOD-affiliated personnel for study participation and for conducting research with military families/children and U.S. Army Special Operations Command populations. Additional information about conducting DOD-funded human research with military populations can be found at https://cdmrp.health.mil/pubs/pdf/Conducting%20Research%20Military%20Pop%20DoD_funded_7NOV2022.pdfCommon Data Elements and Data Sharing: The CDMRP intends that information, data, and research resources generated under this funding opportunity will be made available to the research community (including both the scientific and consumer advocacy communities) and the public at large. Applicants are encouraged to incorporate Common Data Elements (CDEs) appropriate to each field of study, such as the PhenX Core and Specialty collections and National Institute of Neurological Disorders and Stroke (NINDS) TBI CDEs. Note that the CDMRP will not serve as the government sponsor or signatory on any data-sharing agreements. PTSD Researcho Applicants are encouraged to consider the National Institute of Mental Health (NIMH) Data Archive (NDA) as a data-sharing repository for psychological health human subjects data. The NDA provides an infrastructure for sharing research data, tools, methods, and analyses enabling collaborative science and discovery. The NDAs mission is to accelerate scientific research and discovery through data sharing, data harmonization, and the reporting of research results. Consult the NDA website at https://nda.nih.gov for additional information.o While there is no direct charge to users of the NDA, a project estimation tool is available to help estimate costs and manpower needs that may be associated with data submission. TBI Researcho Applicants are required to share all TBI-related clinical research data with at least 50 subjects funded by this program through the jointly supported DOD-National Institutes of Health (NIH) Federal Interagency TBI Research Information System (FITBIR). Recipients will be required to upload study data annually and in accordance with the FITBIR data submission policies. There is no fee to use FITBIR, and detailed guidance and policies, including a cost estimator tool for budgeting considerations, can be found athttps://fitbir.nih.gov.o While there is no direct charge to users of the FITBIR Informatics System, a project estimation tool is available to help estimate costs and manpower needs that may be associated with data submission.Womens Health: The CDMRP encourages research on health areas and conditions that affect women uniquely, disproportionately, or differently from men, including studies analyzing sex as a biological variable. Such research should relate anticipated project findings to improvements in women’s health outcomes and/or advancing knowledge for women’s health.Funding from this award mechanism must support a clinical trial and may not be used for animal or preclinical studies. A clinical trial is defined in the Code of Federal Regulations, Title 45, Part 46.102 (45 CFR 46.102) as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include a placebo or another control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.Studies that do not seek to measure safety, effectiveness, and/or efficacy outcome(s) of an intervention are not considered clinical trials.For more information, a Human Subject Resource Document is provided at https://cdmrp.health.mil/pubs/pdf/Human%20Subjects%20Resource%20Document_DEC2022.pdf.Key aspects of the DMRDP PTRCTA Mechanism: Applicability to Section 723 of the FY24 NDAA: The application must propose to address at least one of the two covered conditions (PTSD and/or TBI) and evaluate at least one of the covered psychedelic substances listed in Section II.B. Clinical Trial Start Date: The proposed clinical trial is expected to begin no later than 6 months after the award date. Preliminary Data Are Required: Inclusion of preliminary data relevant to the proposed clinical trial is required. Study Population: Inclusion of active-duty Service Members, which may include members of the reserve components, is required. Study populations other than Service Members will not be supported. While Veterans are an important population, they are not the focus of this funding opportunity. The outcomes of the study are expected to benefit Service Members, Veterans, and the general public. The application should demonstrate the availability of and access to a suitable population of U.S. Service Members that will support a meaningful outcome for the study. The application should include a discussion of how accrual goals will be achieved, as well as the strategy for inclusion of women and minorities in the clinical trial appropriate to the objectives of the study. Intervention Availability: The application should demonstrate the documented availability of and access to the proposed psychedelic substance and other materials needed, as appropriate, for the proposed duration of the study. Personnel and Environment: The application should demonstrate the study teams expertise and experience in all aspects of conducting clinical trials and working with controlled substances, including appropriate statistical analysis, knowledge of U.S. Food and Drug Administration (FDA) processes (if applicable), enrolling military populations, and data management. The application should include a study coordinator(s) who will guide the clinical protocol through the local Institutional Review Board (IRB) of record and other federal agency regulatory approval processes, coordinate activities from all sites participating in the trial, and coordinate participant accrual. The application should show strong institutional support and, if applicable, a commitment to serve as the FDA regulatory sponsor, ensuring all sponsor responsibilities described in 21 CFR 312, Subpart D, are fulfilled. Statistical Analysis and Data Management Plans: The application should include a clearly articulated statistical analysis plan, a power analysis reflecting sample size projections that will answer the objectives of the study, and a data management plan that includes use of an appropriate database to safeguard and maintain the integrity of the data. If required by a Regulatory Agency, the trial must use a 21 CFR 11-compliant database and appropriate data standards. Drug Enforcement Agency (DEA) Scheduled Substance Application and Licensure: Applications must be made with the United States Department of Justice DEA for work with controlled substances. The application should document the status of the DEA application and licensure in Attachment 9. Additional information can be found at https://www.deadiversion.usdoj.gov/online_forms_apps.html.For the purposes of this funding opportunity, Regulatory Agency refers to the FDA or any relevant international regulatory agency unless otherwise noted.If the proposed clinical trial involves the use of a drug that has not been approved by the relevant Regulatory Agency for the country where the research will be conducted, then submission of an Investigational New Drug (IND) application, or equivalent, that meets all requirements under 21 CFR 312 may be required. It is the responsibility of the applicant to provide evidence from the IRB of record or the relevant Regulatory Agency if an IND application, or equivalent, is not required. If an IND application, or equivalent, is required, the regulatory application must be submitted to the relevant Regulatory Agency by the period of performance start date for applications recommended for funding. The IND application, or equivalent, should be specific for the product and indication to be tested in the proposed clinical trial. For more information on IND applications specifically, the FDA has provided guidance at https://www.fda.gov/drugs/types-applications/investigational-new-drug-ind-application.The funding instrument for awards made under the program announcement will be grants (31 USC 6304).The anticipated total costs budgeted for the entire period of performance for an FY24 DMRDP PTRCTA should not exceed $4.9M. Refer to Section II.D.5, Funding Restrictions, for detailed funding information.Awards supported with FY24 funds will be made no later than September 30, 2025.DHA R expects to allot approximately $9.8M to fund approximately two PTRCTA applications. The government reserves the right to fund additional applications submitted to this funding opportunity if FY25 funding is appropriated for this topic area. Funding of applications received is contingent upon the availability of federal funds for this program, the number of applications received, the quality and merit of the applications as evaluated by peer and programmatic review, and the requirements of the government. Funds to be obligated on any award resulting from this funding opportunity will be available for use for a limited time period based on the fiscal year of the funds. It is anticipated that awards made from this FY24 funding opportunity will be funded with FY24 funds, which will expire for use on September 30, 2030.