Within 5 years, science will likely have answered a controversial question decades in the making: can the psychoactive drug commonly known as ecstasy (3,4-methylenedioxymethamphetamine [MDMA]) be used to treat psychiatric disorders? After positive signals in 2 small trials of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD)^1,2 and unpublished phase 2 work, MDMA investigations are moving into phase 3. Moreover, MDMA-assisted psychotherapy has obtained the breakthrough therapy designation of the US Food and Drug Administration (FDA), which is intended to expedite development and review of novel, potentially effective treatments. The nonprofit organization coordinating this research, the Multidisciplinary Association for Psychedelic Studies (MAPS), estimates that phase 3 studies enrolling at least 200 participants will be completed by 2020, with a new drug application submitted to the FDA shortly thereafter. Of importance, the phase 3 protocols have undergone FDA special protocol assessment, increasing the chances of rapid approval in the event of positive results. Thus, MDMA may be approved for prescription by 2021, necessitating consideration of several important regulatory and clinical issues. Herein, I provide an overview of MDMA-assisted psychotherapy and key associated questions from the viewpoint that these issues need to be considered by psychiatry beyond the small community of MDMA therapy advocates.

在5年内，科学界可能会回答数十年来的一个有争议的问题：通常被称为摇头丸的精神活性药物（3,4-亚甲二氧基甲基苯丙胺[MDMA]）可用于治疗精神疾病吗？后在2个小试验阳性信号MDMA辅助心理治疗创伤后应激障碍（PTSD）^{1 ，2}以及尚未发布的第二阶段工作，MDMA研究正进入第三阶段。此外，MDMA辅助的心理治疗已获得美国食品药品管理局（FDA）的突破性治疗称号，旨在加快新型和潜在有效方法的开发和审查。治疗。负责这项研究的非营利组织，即迷幻研究多学科协会（MAPS）估计，招募至少200名参与者的3期研究将在2020年完成，并在此后不久向FDA提交新药申请。重要的是，第3阶段方案已通过FDA特殊方案评估，增加了在阳性结果中快速批准的机会。因此，MDMA可能会在2021年之前获得处方药的批准，必须考虑几个重要的法规和临床问题。在这里，我提供了MDMA辅助心理治疗的概述以及相关的关键问题，这些观点是精神病学需要MDMA治疗倡导者这一小团体之外的精神病医生考虑的问题。