3,4-Methylenedioxymethamphetamine-assisted psychotherapy for treatment of chronic posttraumatic stress disorder: A randomized phase 2 controlled trial.
3,4-Methylenedioxymethamphetamine-assisted psychotherapy for treatment of chronic posttraumatic stress disorder: A randomized phase 2 controlled trial.
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DOI：
10.1177/0269881118806297
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发表时间：
2018-12
期刊：
影响因子：
--
通讯作者：
Doblin R
中科院分区：
文献类型：
--
作者：
Ot'alora G M;Grigsby J;Poulter B;Van Derveer JW 3rd;Giron SG;Jerome L;Feduccia AA;Hamilton S;Yazar-Klosinski B;Emerson A;Mithoefer MC;Doblin R
创伤后应激障碍在常规的心理治疗或药物治疗后往往无法解决。初步研究报告说，3，4-亚甲二氧基甲基苯丙胺（MDMA）与心理治疗相结合，减少了创伤后应激障碍的症状。这项试点剂量反应试验评估了多个治疗团队中MDMA辅助心理治疗的疗效和安全性。28名慢性创伤后应激障碍患者被随机分配到一个双盲的剂量反应比较中，在8小时的心理治疗过程中给予两种活性剂量（100和125 mg）与低剂量（40 mg）的MDMA。两次MDMA治疗后1个月，临床医生管理的PTSD量表总分的变化作为主要结局。活性剂量组有一个额外的开放标签阶段;低剂量组交叉进行三个开放标签活性剂量阶段。在最后一次MDMA治疗后进行了12个月的随访评估。在意向治疗组中，在主要终点，活性组的临床医生管理的PTSD量表总分降低最大，平均（标准差）-26.3的变化（29.5）对于125 mg，-24.4 100 mg组为-11.5（21.2），40 mg组为-11.5（21.2），但仅在符合方案集中达到统计学显著性（p=0.03）。在12个月的随访中，创伤后应激障碍症状仍然低于基线（p<0.001），76%（n=25）不符合创伤后应激障碍标准。未发生与药物相关的严重不良事件，治疗耐受性良好。我们的研究结果支持以前的调查MDMA辅助心理治疗作为一种创新的，有效的治疗创伤后应激障碍。
Posttraumatic stress disorder often does not resolve after conventional psychotherapies or pharmacotherapies. Pilot studies have reported that 3,4-methylenedioxymethamphetamine (MDMA) combined with psychotherapy reduces posttraumatic stress disorder symptoms. This pilot dose response trial assessed efficacy and safety of MDMA-assisted psychotherapy across multiple therapy teams. Twenty-eight people with chronic posttraumatic stress disorder were randomized in a double-blind dose response comparison of two active doses (100 and 125 mg) with a low dose (40 mg) of MDMA administered during eight-hour psychotherapy sessions. Change in the Clinician-Administered PTSD Scale total scores one month after two sessions of MDMA served as the primary outcome. Active dose groups had one additional open-label session; the low dose group crossed over for three open-label active dose sessions. A 12-month follow-up assessment occurred after the final MDMA session. In the intent-to-treat set, the active groups had the largest reduction in Clinician-Administered PTSD Scale total scores at the primary endpoint, with mean (standard deviation) changes of −26.3 (29.5) for 125 mg, −24.4 (24.2) for 100 mg, and −11.5 (21.2) for 40 mg, though statistical significance was reached only in the per protocol set (p=0.03). Posttraumatic stress disorder symptoms remained lower than baseline at 12-month follow-up (p<0.001) with 76% (n=25) not meeting posttraumatic stress disorder criteria. There were no drug-related serious adverse events, and the treatment was well-tolerated. Our findings support previous investigations of MDMA-assisted psychotherapy as an innovative, efficacious treatment for posttraumatic stress disorder.
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影响因子：
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作者：
KESSLER, RC;SONNEGA, A;NELSON, CB
通讯作者：
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影响因子：
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发表时间：
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