Erica Eaton , Christy Capone , Brian J. Gully , Zoe E. Brown , Mollie Monnig , Michael S. Worden , Robert M. Swift , Carolina L. Haass-Koffler
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Case data from the first study evaluating MDMA-AT study for AUD found the treatment was well tolerated and alcohol use was significantly reduced post treatment.</p></div><div><h3>Methods</h3><p>This manuscript reports the premise, design, and methodology of the first open-label trial of MDMA-AT for military veterans (<em>N</em> = 12) with PTSD and AUD. Neuroimaging and biomarker data are included to evaluate brain changes, and neuroinflammation, pre-post treatment.</p></div><div><h3>Conclusions</h3><p>The clinical component (comorbidity) and the regulatory processes (Schedule I drug) for setting up this clinical trial are long and complex. 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引用次数: 0
摘要
背景创伤后应激障碍（PTSD）和酒精使用障碍（AUD）通常同时存在，而且症状比单独存在的任何一种障碍都严重，自杀风险增加，对现有治疗方法的反应较差。3,4-亚甲二氧基甲基苯丙胺（MDMA）与心理治疗相结合是一种很有前景的治疗干预方法。美国食品和药物管理局（FDA）根据六项二期临床试验的结果，将亚甲二氧基甲基苯丙胺辅助疗法（MDMA-AT）指定为治疗创伤后应激障碍的突破性疗法。本手稿报告了针对患有创伤后应激障碍和 AUD 的退伍军人（N = 12）进行的首次 MDMA-AT 开放标签试验的前提、设计和方法。其中包括神经影像学和生物标志物数据，以评估治疗前和治疗后的大脑变化和神经炎症。结论：建立这项临床试验的临床部分（合并症）和监管过程（一级药物）漫长而复杂。研究界将从这项工作中获益，以建立通用的临床试验结果、标准化方案和风险评估，从而获得 FDA 批准。
Design and methodology of the first open-label trial of MDMA-assisted therapy for veterans with post-traumatic stress disorder and alcohol use disorder: Considerations for a randomized controlled trial
Background
Posttraumatic stress disorder (PTSD) and alcohol use disorder (AUD) commonly co-occur and are associated with more severe symptomatology than either disorder alone, increased risk of suicide, and poorer response to existing treatments. A promising therapeutic intervention is the integration of 3,4-methylenedioxymethamphetamine (MDMA) and psychotherapy. The Food and Drug Administration (FDA) designated MDMA- assisted therapy (MDMA-AT) as a Breakthrough Therapy for PTSD based on results from six Phase 2 clinical trials. Case data from the first study evaluating MDMA-AT study for AUD found the treatment was well tolerated and alcohol use was significantly reduced post treatment.
Methods
This manuscript reports the premise, design, and methodology of the first open-label trial of MDMA-AT for military veterans (N = 12) with PTSD and AUD. Neuroimaging and biomarker data are included to evaluate brain changes, and neuroinflammation, pre-post treatment.
Conclusions
The clinical component (comorbidity) and the regulatory processes (Schedule I drug) for setting up this clinical trial are long and complex. The research community will benefit from this work to establish common clinical trial outcomes, standardized protocols, and risk assessments for FDA approval.
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.
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