Applying for this program can open exciting doors for your business. You have the opportunity to secure up to $4.9 million for clinical trials evaluating psychedelic treatments for PTSD and TBI. This funding can cover everything from trial implementation to research support. By being part of these studies, you contribute to creating new treatment options for Service Members and Veterans who face serious mental health challenges.

Participating could enhance your reputation as an innovator in healthcare research. Securing this funding positions your business in a cutting-edge field with the potential for significant impact. The process to qualify is designed to be manageable, giving you the chance to be at the forefront of groundbreaking advancements. This is not just about funding; it’s about being part of something meaningful that could change lives.

The funding instrument for this opportunity is a grant. Grants do not require repayment, which makes them an attractive option for businesses. You can budget for a total cost of up to $4.9 million for the entire performance period. The funding is available until September 30, 2030, after which unused funds will expire.

Eligible Expenses
Funds can be used for costs directly tied to conducting a clinical trial. This includes expenses for personnel, materials, and necessary interventions related to the research. It’s important to note that grants cannot be allocated towards animal or preclinical studies.

Restrictions and Fees
There are no specific fees associated with this program. However, funds cannot be used for unrelated expenses or costs outside of the clinical trial framework. Always ensure that your proposed budget aligns with the outlined eligible expenses and project requirements.

• Covered Conditions: Must propose research addressing at least one of the two covered conditions: PTSD and/or TBI.
• Psychedelic Substances: Must evaluate at least one of the covered psychedelic substances, which include:
  • MDMA
  • Psilocybin
  • Ibogaine
  • 5-MeO-DMT
  • Plant-based alternative therapies
• Study Population: Must include active-duty Service Members; other populations, including Veterans, are not supported.
• Preliminary Data: Inclusion of preliminary data relevant to the proposed clinical trial is required.
• Clinical Trial Start Date: Proposed clinical trial must start no later than 6 months after the award date.
• Intervention Availability: Must demonstrate availability of the proposed psychedelic substance and other materials needed for the study.
• Personnel and Expertise: The study team must show expertise in conducting clinical trials and working with controlled substances.
• Data Management Plans: Must include a statistical analysis plan, power analysis, and a data management plan.
• DEA Application: Applications need to document the status of the DEA application and licensure for work with controlled substances.

Disqualifications:

• Non-Military Populations: Studies involving populations other than active-duty Service Members are not supported.
• Animal or Preclinical Studies: Funding cannot be used for animal or preclinical studies.
• Veterans Focus: Research focused solely on Veterans is outside the scope of this funding opportunity.

This program provides financial support for clinical trials that explore using psychedelic treatments for conditions like post-traumatic stress disorder (PTSD) and traumatic brain injury (TBI), particularly among U.S. Service Members. You have the chance to be part of studies that could lead to new treatment options for these serious issues affecting many dedicated individuals.

You can apply for up to $4.9 million to fund projects ranging from initial proof-of-concept trials to larger trials that aim to determine the effectiveness of these treatments. The money you receive can be used directly for the clinical trial process, including the treatment itself and necessary research support. Importantly, these funds are not meant for animal or preclinical studies; they must directly support human trials.

The goal is to initiate the trials within six months of receiving funding, allowing you to contribute to significant advancements in mental health treatment for Service Members, Veterans, and their families. This could be a meaningful opportunity for your business to be at the forefront of groundbreaking research.