The METEMP protocol: Massed exposure therapy enhanced with MDMA for PTSD

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications Pub Date : 2025-02-01 DOI:10.1016/j.conctc.2024.101400

Jessica L. Maples-Keller, Boadie W. Dunlop, Barbara O. Rothbaum

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引用次数: 0

Abstract

This article describes the rationale and the specific methods for an open label pilot trial of 100 mg MDMA in combination with massed exposure therapy for PTSD, a treatment which involves daily exposure therapy sessions for two weeks which has found to be effective. We review the need for novel PTSD treatments and the existing research on MDMA-assisted therapy, and then describe the rationale for this novel treatment approach, including combining MDMA with a gold standard treatment, translational support for this treatment, strong dissemination potential, and strengths of providing massed exposure treatment. The specific methods of the open label pilot study are presented, followed by conclusions and future directions for this research. This study will enroll at least 15 adults with PTSD over the next 2 years in order to identify feasibility and lead to a manual describing how to combine MDMA with exposure therapy, tested in a randomized, placebo-controlled trial, with significant promise for dissemination and improving our ability to treat PTSD.

Trial registration

ClinicalTrials.gov identifier: NCT05746572.

查看原文本刊更多论文

METEMP方案：MDMA强化创伤后应激障碍的集中暴露疗法。

这篇文章描述了100mg MDMA联合大规模暴露治疗创伤后应激障碍的开放标签试点试验的基本原理和具体方法，这种治疗包括每天两周的暴露治疗，已被发现是有效的。我们回顾了新型PTSD治疗的需求和MDMA辅助治疗的现有研究，然后描述了这种新型治疗方法的基本原理，包括MDMA与金标准治疗的结合，该治疗的转化支持，强大的传播潜力，以及提供大规模暴露治疗的优势。介绍了开放标签试点研究的具体方法，并给出了结论和未来的研究方向。这项研究将在未来两年内招募至少15名患有创伤后应激障碍的成年人，以确定可行性，并制定一本手册，描述如何将MDMA与暴露疗法结合起来，在一项随机、安慰剂对照试验中进行测试，对传播和提高我们治疗创伤后应激障碍的能力有很大的希望。试验注册：ClinicalTrials.gov标识符：NCT05746572。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology

CiteScore

2.70

自引率

6.70%

发文量

146

审稿时长

20 weeks

期刊介绍： Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.