Progress for Research Funding on Psychedelics for Military Personnel and Veterans/First Responders

Increasing Access and Knowledge Base for Therapeutic Use of Psychedelics for Mental Health Conditions

The use of psychedelics to treat certain mental health conditions has garnered attention from legislators at both the federal and state levels. Although medicinal use of psychedelics is still limited to use in only certain approved research, recent legislative steps discussed below represent significant progress toward more widespread availability of this kind of treatment for such conditions as post-traumatic stress disorder (PTSD) and traumatic brain injury.

The National Defense Authorization Act (NDAA) for Fiscal Year 2024¹, passed by Congress and signed into law by President Biden on December 22, 2023, contains provisions to fund studies on therapeutic use of psychedelics for military service members. This is a significant development, as it indicates a growing interest and recognition at the federal level of the potential therapeutic benefits of psychedelics, particularly in treating conditions like PTSD, which are prevalent among military personnel. Similarly, a recently introduced New York State bill, if passed, would create a pilot program for psilocybin-assisted therapy for 10,000 military veterans and first responders.

National Defense Authorization Act for Fiscal Year 2024 – Pub. L. No. 118-31, § 723, 137 Stat. 136

The NDAA contains a section (sec. 723) for a U.S. Department of Defense program to fund eligible entities (federal and state government departments/agencies and academic institutions) to conduct research on covered psychedelics for eligible members of the Armed Forces for certain covered conditions (post-traumatic stress and traumatic brain injury).

In this program, “covered psychedelic substances” are defined as including MDMA (3,4-methylenedioxy-methamphetamine), psilocybin, ibogaine, 5-MeO-DMT (5-methoxy-N,N-dimethyltryptamine) and qualified plant-based alternative therapies. Pub. L. No. 118-31, § 723(e)(2)(A)-(E).

Ten million dollars have been authorized for the clinical research on psychedelic treatments. Section 723 stipulates that the Secretary of Defense may approve any active duty member of the Armed Forces diagnosed with a covered condition to take part in a clinical trial that is conducted via funding awarded under this section. A report on the funding awarded, including findings from the clinical trials, would be due to the Committees on Armed Services of the House of Representatives and the Senate within one year of enactment and annually thereafter for three years.

New York Bill: A. 8349

On December 13, 2023, New York State Assemblymember Patrick Burke (D) introduced Bill No. A. 8349², in which the New York State Department of Health (NYSDOH) would institute a pilot program providing funding for 10,000 veterans and first responders to receive psilocybin-assisted therapy in order to document the therapy’s effects on their conditions. This state-level initiative aligns with the growing body of research suggesting the benefits of psilocybin, a psychedelic compound, in treating certain mental health conditions.

The New York bill proposes that participants include veterans and their families, first responders and retired first responders, and individuals suffering from cluster headaches, located in Western New York.

Completion of a training course would be required to become a facilitator for psilocybin-assisted therapy. Facilitators include mental health counselors, psychoanalysts, physicians, physician assistants, registered nurses, clinical nurse specialists, nurse practitioners, occupational therapists, occupational therapy assistants, licensed clinical social workers, or individuals with prior knowledge or experience in the field of psychedelic-assisted therapy. The emphasis by New York on facilitators holding professional licenses and/or having prior experience with psychedelic-assisted therapy is significant and differs from the Oregon Psilocybin Services program, where holding a professional license is not included among the requirement for becoming a licensed facilitator.³

The NYSDOH would be able to provide analysis and evaluation of the pilot program as well as enter into agreements with individuals, non-profits, universities or other organizations to evaluate the pilot program. The NYSDOH would seek any necessary federal approval of the pilot and would report results of the program to the governor and the legislature no later than two years after this bill’s passage and every two years thereafter. The pilot program would end upon the approval of psilocybin for medical use by the federal drug enforcement administration or any successor agency.

The bill stipulates that patients, facilitators and practitioners would not be subject to prosecution, arrest or penalty for their involvement in the pilot, and that a patient’s participation would not be held against them in a court proceeding. Individuals under parole, probation or other state/local supervision would not be penalized for taking part in the pilot.

Patient information would not be publicly disclosed, but the name, contact information and other information of facilitators would be public information, unless they indicate in writing their desire for anonymity.

The bill has been referred to the Standing Committee on Health.

Implications

Both bills reflect the government’s increasing recognition of the need to study the potential therapeutic utility of psychedelics for treatments of serious conditions such as PTSD affecting service members. The relationship between the NDAA and the New York bill can be seen in their shared interest in exploring and potentially legitimizing the use of psychedelics as a therapeutic tool, especially for individuals such as military personnel and first responders who are often at a higher risk of mental health disorders due to the nature of their work. The NDAA’s provision for research into psychedelics at a federal level could support and potentially influence state-level initiatives like the New York bill by contributing to the overall body of research and understanding of psychedelics’ therapeutic potential. This increasing recognition by federal and state governments of the potential therapeutic utility of psychedelics has implications for researchers and drug developers regarding governmental receptivity to finding―and funding―new solutions for mental health conditions. Mental health providers and health care facilities interested in providing psychedelic-assisted therapies should also see this as a promising signal of the potential opportunities to come as medicinal psychedelics move closer to U.S. Food and Drug Administration approval.

Additional Assistance

For further assistance, please contact a member of our Psychedelics and Mental Health Therapeutics Practice Team or the Phillips Lytle attorney with whom you have a relationship.