(PS4-90) Lessons Learned from Four MDMA-Assisted Therapy Trials in the Veterans Affairs Healthcare System

Background: Research on MDMA-assisted therapy (MDMA-AT) for post-traumatic stress disorder (PTSD) has substantially increased over the past decade. This has contributed to growing interest among U.S. Veterans and service members who are disproportionately impacted by PTSD and in search of innovative treatments. However, there has been limited research on MDMA-AT for PTSD in this population and within large healthcare systems such as the Veterans Health Administration (VHA). VHA is perhaps the largest system of care globally providing PTSD treatment; therefore, it is critical to understand what barriers and facilitators exist in implementing clinical trials of MDMA-AT with Veterans seeking PTSD care in large healthcare systems like VHA.

Method: Clinical trial implementation challenges and opportunities will be examined across four unique clinical trials at three VA healthcare systems: San Diego, California (MDMA-assisted Brief Cognitive Behavioral Conjoint Therapy for PTSD, N = 16 Veterans and their partners; MDMA-assisted Massed Prolonged Exposure Therapy for PTSD, N = 10 Veterans), Loma Linda, California (MDMA-assisted Therapy for Combat Refractory PTSD, N = 10 Veterans) and Portland, Oregon (Group MDMA-assisted Therapy for Veterans with PTSD, N = 18 Veterans). Drawing from recruitment data and qualitative observations, we describe the lessons learned during the recruitment and screening, treatment, and post-treatment stages of each study. This presentation will also address the complications of medication tapering for eligibility, logistical challenges, and other valuable feedback from providers and participants.

Results: Several challenges were identified. Notably, while many Veterans have been interested in participating in MDMA-AT for PTSD studies, the vast majority have not been eligible due to the extensive medical and psychiatric eligibility criteria and significant time commitment. Despite these challenges, there are also multiple opportunities afforded by conducting research in this setting. Specifically, the comprehensive nature and medical infrastructure of the VHA medical care system allows for detailed screening as well as collaboration between veterans’ research teams and clinical teams, improving overall continuity and quality of care.

Discussion: In MDMA-AT for PTSD trials conducted in VHA, there are unique challenges and opportunities that exist at each stage of the study process, spanning from initial screening to after treatment completion. With more MDMA-AT for PTSD projects on the horizon, it is especially important for future investigators to be aware of the realities of conducting this important research in large healthcare systems like VHA, so that they may optimize future research efforts to best serve the mental health needs of our Veterans.