A clinical plan for MDMA (Ecstasy) in the treatment of posttraumatic stress disorder (PTSD): Partnering with the FDA
A clinical plan for MDMA (Ecstasy) in the treatment of posttraumatic stress disorder (PTSD): Partnering with the FDA
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DOI：
10.1080/02791072.2002.10399952
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发表时间：
2002-04-01
影响因子：
2.8
通讯作者：
Doblin, R
中科院分区：
文献类型：
--
作者：
Doblin, R
FDA和西班牙卫生部得出结论，在某些情况下，MDMA辅助心理治疗的临床研究的风险/受益比是有利的。这两个机构都批准了在慢性创伤后应激障碍（PTSD）患者中进行的试点研究，这些患者未能从至少一个常规治疗过程中获得缓解。这些研究是世界上唯一一项关于MDMA治疗用途的研究，由非营利研究和教育组织多学科迷幻研究协会（MAPS，www.example.com）资助。提供了一个理由来解释为什么MAPS选择将其有限的资源集中在MDMA和PTSD患者。一个临床计划是详细的进行“充分和良好的控制”的试验，以评估MDMA辅助心理治疗创伤后应激障碍的安全性和有效性，与研究估计耗资约500万美元，需要大约五年。临床计划的制定，部分是通过对辉瑞公司成功地使左洛复获得FDA批准用于创伤后应激障碍患者的研究进行分析，并通过审查FDA精神药理学药物咨询委员会会议的记录，该会议建议批准左洛复治疗创伤后应激障碍。
The FDA and the Spanish Ministry of Health have concluded that the risk/benefit ratio is favorable under certain circumstances for clinical studies investigating MDMA-assisted psychotherapy. Both agencies have approved pilot studies in chronic posttraumatic stress disorder (PTSD) patients who have failed to obtain relief from at least one course of conventional treatment. These studies, the only ones in the world into the therapeutic use of MDMA, are being funded by a nonprofit research and educational organization, the Multidisciplinary Association for Psychedelic Studies (MAPS, www.maps.org). A rationale is offered explaining why MAPS chose to focus its limited resources on MDMA, and also on PTSD patients. A Clinical Plan is elaborated for the conduct of the "adequate and well-controlled" trials necessary to evaluate the safety and efficacy of MDMA-assisted psychotherapy for PTSD, with the studies estimated to cost about $5 million and to take about five years. The Clinical Plan has been developed, in part, through analysis of the studies conducted by Pfizer in its successful effort to have Zoloft approved by the FDA for use with PTSD patients, and through review of transcripts of the FDA's Psychopharmacologic Drugs Advisory Committee meeting that recommended approval of Zoloft for PTSD.