Expert Opinions on Implementation of MDMA-Assisted Therapy in Europe: Critical Appraisal towards Training, Clinical Practice, and Regulation

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.

引言：亚甲二氧基甲基苯丙胺（MDMA）辅助疗法（MDMA-AT）用于创伤后应激障碍（PTSD）治疗的临床应用已取得积极成果，亟需对其在欧洲精神卫生医疗体系中的监管地位开展批判性评估。此举的动因在于，美国近期已向美国食品药品监督管理局（FDA）提交MDMA-AT的上市批准申请。若欧洲监管领域未启动协同举措，各国监管策略或将出现潜在分歧。吸纳参与MDMA-AT临床应用的研究人员与临床医师的见解，可为探讨该疗法落地实施的相关影响因素提供有益参考。
方法：本研究采用定向邀请式综合调研，向参与MDMA-AT临床试验、且为MDMA-AT相关科学文献作出贡献的研究人员与临床医师发放问卷，旨在收集关于临床实践、培训与监管的相关意见。
结果：本次调研共回收70位专家的有效回复，专家意见呈现多样化分布：绝大多数受访者认可开展培训与标准化建设的必要性，强调公平性与可及性，指出各国审批流程中存在的阻碍，并对MDMA-AT在临床场景中可能产生的外溢效应展开批判性反思。
结论：专家们强调，需制定以科学为依据的政策，推动监管机构积极参与，开展国际合作，以将MDMA-AT全面纳入欧洲精神卫生医疗体系，尤其用于创伤后应激障碍的治疗。本研究同时强调，持续开展研究、开放专业对话与多方协同参与，对推动MDMA-AT的合规且高效落地具有重要意义。