Psychedelic-Assisted Therapy in Military and Veterans Healthcare Systems: Clinical, Legal, and Implementation Considerations.

MDMA- and psilocybin-assisted therapy have shown promising outcomes for PTSD and depression, respectively. MDMA-assisted therapy is already FDA-approved on a compassionate use basis for PTSD, with full approval projected for 2024; psilocybin-assisted therapy is projected to be approved for depression soon after. The VA is conducting clinical trials, but implementation barriers include high clinical hours per patient, resource requirements, military-specific considerations, and the need for strong evidence before inclusion in clinical guidelines. Policymakers in the DoD and VA must prepare clear policies for these treatments as FDA approval approaches.

Study at a glance

Abstract

This review discusses the current and projected landscape of psychedelic-assisted therapy (PAT), with a focus on clinical, legal, and implementation considerations in Department of Defense (DoD) and Department of Veterans Affairs (VA) healthcare systems. 3,4-Methylenedioxymethamphetamine (MDMA)- and psilocybin-assisted therapy have shown promising outcomes in efficacy, safety, tolerability, and durability for PTSD and depression, respectively. MDMA-assisted therapy is already approved by the Food and Drug Administration (FDA) on an Expanded Access ("compassionate use") basis for PTSD, with full approval projected for 2024. Psilocybin-assisted therapy is projected to be FDA-approved for depression soon thereafter. Other psychedelics are in earlier stages of development. The VA is currently conducting PAT clinical trials. Although there are clear legal pathways for the VA and DoD to conduct PAT trials, a number of implementation barriers exist, such as the very high number of clinical hours necessary to treat each patient, resource requirements to support treatment infrastructure, military-specific considerations, and the high level of evidence necessary for PAT to be recommended in clinical practice guidelines. Ongoing considerations are whether and how PAT will be made available to VA and DoD beneficiaries, feasibility and cost-effectiveness, and ethical safeguards that must be implemented to prioritize access to PAT given the likelihood of extremely limited initial availability. However, with imminent FDA approval of PATs and considerable national interest in these treatments, DoD and VA policymakers must be prepared with clearly delineated policies and plans for how these healthcare systems will approach PAT.