Abstract：
Recent years have seen a resurgence in randomized, placebo controlled trials (RCTs) utilizing non-classical psychedelics (e.g. 3,4-methyl enedioxy methamphetamine [MDMA]), and classical psychedelics (e.g. psilocybin, lysergic acid diethylamide [LSD], and N,N-dimethyltryptamine [DMT/ayahuasca]) in conjunction with assisted therapy (AT) for psychiatric disorders. A notable methodological challenge in psychedelic AT, however, is the complexity of blinding procedures. The lack of efficacious blinding can introduce considerable response bias, reduce internal validity, and compromise participant retention. This systematic review examines design and blinding techniques in RCTs utilizing psychedelics and placebo for the treatment of psychiatric disorders. The aim of this work is to identify factors that may inform future RTC design for conducting psychedelics research. We conducted a systematic review of PubMed, MEDLINE, CINAHL, Cochrane Central Register of Controlled Trials (CENTRAL), Psycinfo, Embase, and Web of Science Core Collection to examine: (1) placebo selection, (2) study design, and (3) integrity of blinding measures. Sixteen publications were identified as meeting the criteria for a systematic review. Our findings suggest that traditional placebo administration is insufficient to control for expectancy confounds. Consequently, experimental methodology that limits personnel unblinding and the use of an active placebo are important considerations when designing prospective clinical studies involving psychedelics.
摘要：
近年来，随机疗法的复苏，使用非经典迷幻药（例如3,4-甲基二氧基甲基苯丙胺[MDMA]）的安慰剂对照试验（RCT），和经典的迷幻药(例如psilocybin，麦角酰二乙胺[LSD]，N,N-二甲基色胺[DMT/ayahuasca]）与辅助治疗（AT）联合治疗精神疾病。迷幻AT中一个值得注意的方法论挑战，然而,是盲法程序的复杂性。缺乏有效的致盲可能会引入相当大的响应偏差，降低内部有效性，并妥协参与者的保留。本系统综述研究了使用迷幻药和安慰剂治疗精神疾病的RCT的设计和致盲技术。这项工作的目的是确定可能为进行迷幻药研究的未来RTC设计提供信息的因素。我们对PubMed进行了系统回顾，MEDLINE,CINAHL,Cochrane中央对照试验登记册（中央），Psycinfo,Embase,和WebofScience核心合集进行检查：(1)安慰剂选择，（2）研究设计，(3)盲法措施的完整性。16种出版物被确定为符合系统审查的标准。我们的发现表明，传统的安慰剂给药不足以控制预期混淆。因此,在设计涉及迷幻药的前瞻性临床研究时,限制人员脱盲和使用活性安慰剂的实验方法学是重要考虑因素.
