Expert Opinions on Implementation of MDMA-Assisted Therapy in Europe: Critical Appraisal towards Training, Clinical Practice, and Regulation
Description
Introduction: The positive results of the clinical use of MDMA in MDMA-assisted therapy (MDMA-AT) for the treatment of post-traumatic stress disorder (PTSD) call for a critical evaluation of its regulatory status within the European mental healthcare system. This is driven by the recent submission of MDMA-AT for FDA approval in the United States. Unless coordinated efforts in the European regulatory landscape start, there may be potential divergences in national regulatory strategies. Gaining insights from researchers and clinicians involved in the application of MDMA-AT may be useful to guide in discussion of factors involved in its implementation. Method: A comprehensive invitation-only survey was sent to researchers and clinicians involved in MDMA-AT clinical trials and contributors to the scientific literature on MDMA-AT. This study aimed to collect opinions on clinical practices, training, and regulation. Results: The survey, which included responses from 70 experts, yielded a range of opinions where a large majority endorsed the need for training and standardization, emphasizing equity and access, stressing impediments in the national approval processes, and reflected critically on anticipated spill-over effects of MDMA-AT in clinical settings. Conclusion: The experts highlight the need for science-informed policy development, active regulatory involvement, international cooperation to incorporate MDMA-AT into the European mental healthcare system in general and the treatment of PTSD in particular. The study emphasizes the importance of ongoing research, open professional discourse, and collaborative engagement to facilitate MDMA-AT's ethical and effective implementation.