Expert opinions on implementation of MDMA-assisted therapy in Europe: critical appraisal towards training, clinical practice, and regulation

Introduction: The positive results of MDMA from Phase 2 and 3 clinical trials 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 in guiding the 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 from around the globe. This study aimed to collect opinions on clinical practices, training, and regulation worldwide, examining the global best practices and pitfalls to outline strategies for possible European implementation of MDMA-AT.Results: The survey, which included responses from 68 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 reflecting 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, and 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. Positive clinical trials of therapy using MDMA for treating post-traumatic stress disorder (PTSD) call for a thorough review of its regulatory status in Europe, especially following its submission for approval in the United States.A global survey of 68 researchers and clinicians underscores the necessity for standardized training, equitable access, and streamlined national approval processes for MDMA therapy, highlighting potential clinical benefits and challenges.Experts emphasize the importance of science-based policies, international cooperation, and continuous research to effectively integrate MDMA therapy into European mental healthcare for PTSD treatment. Introducci & oacute;n: Los resultados positivos de la MDMA en los ensayos cl & iacute;nicos de fase 2 y 3 en terapia asistida por MDMA (MDMA-AT) para el tratamiento del trastorno de estr & eacute;s postraum & aacute;tico (TEPT) exigen una evaluaci & oacute;n cr & iacute;tica de su situaci & oacute;n regulatoria dentro del sistema de asistencia sanitaria mental europeo. Esto se debe a la reciente presentaci & oacute;n de MDMA-AT para la aprobaci & oacute;n de la FDA en los Estados Unidos. A menos que se inicien esfuerzos coordinados en el panorama regulatorio europeo, puede haber posibles divergencias en las estrategias regulatorias nacionales. Obtener conocimientos de investigadores y m & eacute;dicos involucrados en la aplicaci & oacute;n de MDMA-AT puede ser & uacute;til para guiar la discusi & oacute;n de los factores involucrados en su implementaci & oacute;n.M & eacute;todo: Se envi & oacute; una encuesta exhaustiva solo por invitaci & oacute;n a investigadores y m & eacute;dicos involucrados en ensayos cl & iacute;nicos de MDMA-AT y contribuyentes a la literatura cient & iacute;fica sobre MDMA-AT de todo el mundo. Este estudio tuvo como objetivo recopilar opiniones sobre las pr & aacute;cticas cl & iacute;nicas, la formaci & oacute;n y la regulaci & oacute;n en todo el mundo, examinando las mejores pr & aacute;cticas y los obst & aacute;culos globales para delinear estrategias para una posible implementaci & oacute;n europea de MDMA-AT.Resultados: La encuesta, que incluy & oacute; respuestas de 68 expertos, arroj & oacute; una variedad de opiniones donde una gran mayor & iacute;a respald & oacute; la necesidad de capacitaci & oacute;n y estandarizaci & oacute;n, enfatizando la equidad y el acceso, destacando los impedimentos en los procesos de aprobaci & oacute;n nacional y reflexionando cr & iacute;ticamente sobre los efectos de desbordamiento o indirectos anticipados de MDMA-AT en entornos cl & iacute;nicos.Conclusi & oacute;n: Los expertos destacan la necesidad de desarrollo de pol & iacute;ticas basadas en la ciencia, participaci & oacute;n regulatoria activa y cooperaci & oacute;n internacional para incorporar MDMA-AT al sistema europeo de salud mental en general y al tratamiento del TEPT en particular. El estudio enfatiza la importancia de la investigaci & oacute;n continua, el discurso profesional abierto y el compromiso colaborativo para facilitar la implementaci & oacute;n & eacute;tica y efectiva de MDMA-AT.