A randomized, controlled pilot study of MDMA (±3,4-Methylenedioxymethamphetamine)-assisted psychotherapy for treatment of resistant, chronic Post-Traumatic Stress Disorder (PTSD)

A randomized, controlled pilot study of MDMA (±3,4-Methylenedioxymethamphetamine)-assisted psychotherapy for treatment of resistant, chronic Post-Traumatic Stress Disorder (PTSD)
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DOI:
10.1177/0269881112464827
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发表时间:
2013-01-01
影响因子:
4.1
通讯作者:
Schnyder, Ulrich
Schnyder, Ulrich
中科院分区:
医学3区
文献类型:
--
作者:
Oehen, Peter;Traber, Rafael;Schnyder, Ulrich

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美国(1970-1985)和瑞士(1988-1993)的精神病学家和心理治疗师合法地将MDMA作为处方药使用,以增强心理治疗的有效性。早期的报告表明,它在治疗创伤相关疾病方面很有用。最近,首次完成的MDMA辅助心理疗法治疗创伤后应激障碍的初步研究取得了令人鼓舞的结果。旨在测试MDMA辅助治疗难治性创伤后应激障碍患者的安全性和有效性;我们的随机、双盲、积极安慰剂对照试验招募了12名患者,接受低剂量(25毫克,加上12.5毫克补充剂量)或全剂量MDMA(125毫克,加上62.5毫克补充剂量)治疗。在三次实验期间给予MDMA,并穿插在每周的非药物心理治疗会议上。结果采用临床医生创伤后应激障碍评定量表(CAPS)和创伤后诊断评定量表(PDS)。患者在基线、第二次和第三次MDMA治疗(治疗结束)后三周,以及两个月和一年的随访中进行评估。我们发现MDMA辅助的心理治疗在临床环境中可以安全地实施。未发生与药物有关的严重不良事件。我们没有看到CAPS评分在统计学上显著降低(p=0.066),尽管在临床和统计学上有显著的自我报告改善(p=0.014)。在1年的随访中,CAPS评分进一步提高。此外,三次MDMA会议比两次会议更有效(p=0.016)。
Psychiatrists and psychotherapists in the US (1970s to 1985) and Switzerland (1988-1993) used MDMA legally as a prescription drug, to enhance the effectiveness of psychotherapy. Early reports suggest that it is useful in treating trauma-related disorders. Recently, the first completed pilot study of MDMA-assisted psychotherapy for PTSD yielded encouraging results. Designed to test the safety and efficacy of MDMA-assisted psychotherapy in patients with treatment-resistant PTSD; our randomized, double-blind, active-placebo controlled trial enrolled 12 patients for treatment with either low-dose (25 mg, plus 12.5 mg supplemental dose) or full-dose MDMA (125 mg, plus 62.5 mg supplemental dose). MDMA was administered during three experimental sessions, interspersed with weekly non-drug-based psychotherapy sessions. Outcome measures used were the Clinician-Administered PTSD Scale (CAPS) and the Posttraumatic Diagnostic Scale (PDS). Patients were assessed at baseline, three weeks after the second and third MDMA session (end of treatment), and at the 2-month and 1-year follow-ups.We found that MDMA-assisted psychotherapy can be safely administered in a clinical setting. No drug-related serious adverse events occurred. We did not see statistically significant reductions in CAPS scores (p = 0.066), although there was clinically and statistically significant self-reported (PDS) improvement (p = 0.014). CAPS scores improved further at the 1-year follow-up. In addition, three MDMA sessions were more effective than two (p = 0.016).