Sessa Ben, Sakal Chloe, O'Brien Steve, Nutt David
Neuropsychopharmacology, Department of Medicine, Imperial College London, London, UK.
Department of Medicine, Avon and Wiltshire Mental Health Partnership NHS Trust, Bath, UK.
BMJ Case Rep. 2019 Jul 15;12(7):e230109. doi: 10.1136/bcr-2019-230109.
We present the preliminary data in an ongoing open-label safety and tolerability proof of concept study exploring the potential role for 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy in treating patients with alcohol use disorder. At this stage, seven participants have completed the full 8-week MDMA-assisted psychotherapy course, including two therapy sessions each with MDMA. This paper focuses on the safety and tolerability of the therapeutic course for the first four participants to complete treatment. Longer-term outcomes of drinking behaviour will be presented later when the full project data are published. Results show all four participants have successfully tolerated the treatment. There have been no serious adverse events related to MDMA, no unexpected physiological responses to the MDMA sessions or changes to blood results or electrocardiograms, measured before and after the 8-week course. We conclude that the treatment is well- tolerated and are making plans to expand the project into a randomised placebo-controlled study.
我们在一项正在进行的开放标签安全性和耐受性概念验证研究中展示了初步数据，该研究探索了3,4-亚甲基二氧甲基苯丙胺（摇头丸）辅助心理治疗在治疗酒精使用障碍患者中的潜在作用。在此阶段，七名参与者已完成了为期8周的完整摇头丸辅助心理治疗课程，包括每次使用摇头丸的两次治疗。本文重点关注前四名完成治疗的参与者治疗过程的安全性和耐受性。饮酒行为的长期结果将在整个项目数据发表后再呈现。结果显示，所有四名参与者都成功耐受了治疗。在为期8周的疗程前后测量，没有与摇头丸相关的严重不良事件，没有对摇头丸治疗产生意外的生理反应，血液检查结果或心电图也没有变化。我们得出结论，该治疗耐受性良好，并正在计划将该项目扩展为一项随机安慰剂对照研究。
