Centre for Eudaimonia and Human Flourishing, University of Oxford, Oxford, United Kingdom.
Department of Psychiatry, University of Oxford, Oxford, United Kingdom.
Am J Ther. 2024;31(2):e141-e154. doi: 10.1097/MJT.0000000000001722.
After becoming notorious for its use as a party drug in the 1980s, 3,4-methylenedioxy-methampetamine (MDMA), also known by its street names "molly" and "ecstasy," has emerged as a powerful treatment for post-traumatic stress disorder (PTSD).
There are extensive data about the risk profile of MDMA. However, the literature is significantly biased. Animal models demonstrating neurotoxic or adverse effects used doses well beyond the range that would be expected in humans (up to 40 mg/kg in rats compared with roughly 1-2 mg/kg in humans). Furthermore, human samples often comprise recreational users who took other substances in addition to MDMA, in uncontrolled settings.
Phase III clinical trials led by the Multidisciplinary Association for Psychedelic Studies (MAPS) have shown that MDMA-assisted psychotherapy has an effect size of d = 0.7-0.91, up to 2-3 times higher than the effect sizes of existing antidepressant treatments. 67%-71% of patients who undergo MDMA-assisted psychotherapy no longer meet the diagnostic criteria for PTSD within 18 weeks. We also describe other promising applications of MDMA-assisted psychotherapy for treating alcohol use disorder, social anxiety, and other psychiatric conditions.
Thus far, almost all clinical trials on MDMA have been sponsored by a single organization, MAPS. More work is needed to determine whether MDMA-assisted therapy is more effective than existing nonpharmacological treatments such as cognitive behavioral therapy.
Phase III trials suggest that MDMA is superior to antidepressant medications for treating PTSD. Now that MAPS has officially requested the Food and Drug Administration to approve MDMA as a treatment for PTSD, legal MDMA-assisted therapy may become available as soon as 2024.
20 世纪 80 年代，3,4-亚甲二氧基甲基苯丙胺（MDMA）因作为派对药物而声名狼藉，此后已成为治疗创伤后应激障碍（PTSD）的有效药物。
有大量关于 MDMA 风险概况的数据。然而，文献存在严重的偏差。动物模型显示神经毒性或不良反应的剂量远远超出了人类预期的范围（大鼠的剂量高达 40mg/kg，而人类的剂量约为 1-2mg/kg）。此外，人类样本通常由除 MDMA 之外还服用了其他物质的娱乐性使用者组成，而且这些人是在不受控制的环境下使用的。
多学科迷幻药物研究协会（MAPS）领导的 III 期临床试验表明，MDMA 辅助心理治疗的效果大小为 d=0.7-0.91，比现有抗抑郁药物治疗的效果高出 2-3 倍。在 18 周内，接受 MDMA 辅助心理治疗的患者中，有 67%-71%不再符合 PTSD 的诊断标准。我们还描述了 MDMA 辅助心理治疗在治疗酒精使用障碍、社交焦虑和其他精神疾病方面的其他有前途的应用。
迄今为止，几乎所有关于 MDMA 的临床试验都是由一个单一的组织 MAPS 赞助的。需要做更多的工作来确定 MDMA 辅助治疗是否比现有的非药物治疗方法（如认知行为疗法）更有效。
III 期试验表明，MDMA 治疗 PTSD 的效果优于抗抑郁药物。由于 MAPS 已正式向美国食品和药物管理局（FDA）请求批准 MDMA 作为 PTSD 的治疗药物，合法的 MDMA 辅助治疗可能最早在 2024 年就可以获得。
