The safety and efficacy of {+/-}3,4-methylenedioxymethamphetamine-assisted psychotherapy in subjects with chronic, treatment-resistant posttraumatic stress disorder: the first randomized controlled pilot study.
The safety and efficacy of {+/-}3,4-methylenedioxymethamphetamine-assisted psychotherapy in subjects with chronic, treatment-resistant posttraumatic stress disorder: the first randomized controlled pilot study.
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DOI：
10.1177/0269881110378371
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发表时间：
2011-04
期刊：
影响因子：
--
通讯作者：
Doblin R
中科院分区：
文献类型：
--
作者：
Mithoefer MC;Wagner MT;Mithoefer AT;Jerome L;Doblin R
案例报告表明，在1985年娱乐性使用MDMA作为“摇头丸”导致其被定罪之前，精神科医生使用了±3,4-亚甲基二氧甲基苯丙胺（MDMA）作为心理治疗的催化剂。二十多年后，这项研究是第一个完成的评估MDMA作为治疗辅助药物的临床试验。20例对心理治疗和精神药理学均难治的慢性创伤后应激障碍患者，在两个8小时的实验性心理治疗疗程中，随机分为两组，分别服用有效药物（n = 12）和无效安慰剂（n = 8）。两组均接受预备和随访的非药物心理治疗。主要的结果测量是临床医生管理的PTSD量表，在基线、每次实验后4天和第二次实验后2个月进行。进行神经认知测试、血压和体温监测。在2个月的随访后，安慰剂受试者可以选择重新加入开放标签MDMA的实验程序。在基线后的所有三个时间点上，接受MDMA组的临床给药PTSD量表得分较基线的下降明显大于安慰剂组。积极治疗组的临床缓解率为10/12(83%)，安慰剂组为2/8（25%）。没有药物相关的严重不良事件、不良的神经认知效应或临床显著的血压升高。mdma辅助心理治疗可用于创伤后应激障碍患者而无伤害证据，它可能对其他治疗难治性的患者有用。
Case reports indicate that psychiatrists administered ±3,4-methylenedioxymethamphetamine (MDMA) as a catalyst to psychotherapy before recreational use of MDMA as ‘Ecstasy’ resulted in its criminalization in 1985. Over two decades later, this study is the first completed clinical trial evaluating MDMA as a therapeutic adjunct. Twenty patients with chronic posttraumatic stress disorder, refractory to both psychotherapy and psychopharmacology, were randomly assigned to psychotherapy with concomitant active drug (n = 12) or inactive placebo (n = 8) administered during two 8-h experimental psychotherapy sessions. Both groups received preparatory and follow-up non-drug psychotherapy. The primary outcome measure was the Clinician-Administered PTSD Scale, administered at baseline, 4 days after each experimental session, and 2 months after the second session. Neurocognitive testing, blood pressure, and temperature monitoring were performed. After 2-month follow-up, placebo subjects were offered the option to re-enroll in the experimental procedure with open-label MDMA. Decrease in Clinician-Administered PTSD Scale scores from baseline was significantly greater for the group that received MDMA than for the placebo group at all three time points after baseline. The rate of clinical response was 10/12 (83%) in the active treatment group versus 2/8 (25%) in the placebo group. There were no drug-related serious adverse events, adverse neurocognitive effects or clinically significant blood pressure increases. MDMA-assisted psychotherapy can be administered to posttraumatic stress disorder patients without evidence of harm, and it may be useful in patients refractory to other treatments.
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