失控:致幻剂试验中的盲法、剂量反应和社会心理控制。

IF 5.5 3区 医学 Q1 CLINICAL NEUROLOGY
Sandeep M Nayak, Zarmeen Zahid
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引用次数: 0

摘要

随着迷幻药临床试验在规模和影响上的扩大,试验设计中的基本挑战变得更加突出。在这篇评论中,我们研究了三个相互关联的问题:1)致幻剂试验中盲法的失败,2)替代对照的潜力,包括作为经验解决方案的剂量反应设计,以及3)围绕社会心理控制条件的持续模糊。我们认为,由于致幻剂明显的主观效应和这些效应本身的治疗相关性,保留传统安慰剂控制框架的努力往往是不够的。相反,我们强调替代设计,包括分级剂量比较和非盲法比较疗效研究,作为务实的前进道路。最后,我们概述了一项建议,从经验上隔离心理治疗在迷幻治疗中的作用,强调需要操作定义,保真度监测和谨慎的风险缓解。这些问题不可能通过任何单一的设计来解决;更确切地说,取得进展需要在多种不完善但互补的方法之间对证据进行三角测量。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Out of control: Blinding, dose response, and psychosocial controls in psychedelic trials.

As psychedelic clinical trials expand in scale and influence, foundational challenges in trial design have come into sharper focus. In this commentary, we examine three interrelated issues: 1) the failure of blinding in psychedelic trials, 2) the potential of alternate controls including dose-response designs as an empirical workaround, and 3) the persistent ambiguity surrounding psychosocial control conditions. We argue that efforts to preserve traditional placebo-controlled frameworks are often inadequate due to the unmistakable subjective effects of psychedelics and the therapeutic relevance of those effects themselves. Instead, we highlight alternative designs including graded dose comparisons and unblinded comparative efficacy studies as pragmatic paths forward. Finally, we outline a proposal for empirically isolating the role of psychotherapy in psychedelic treatment, emphasizing the need for operational definitions, fidelity monitoring, and careful risk mitigation. These issues are unlikely to be resolved by any single design; rather, progress will require triangulating evidence across multiple imperfect but complementary methodologies.

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来源期刊
Journal of Psychopharmacology
Journal of Psychopharmacology 医学-精神病学
CiteScore
8.60
自引率
4.90%
发文量
126
审稿时长
3-8 weeks
期刊介绍: The Journal of Psychopharmacology is a fully peer-reviewed, international journal that publishes original research and review articles on preclinical and clinical aspects of psychopharmacology. The journal provides an essential forum for researchers and practicing clinicians on the effects of drugs on animal and human behavior, and the mechanisms underlying these effects. The Journal of Psychopharmacology is truly international in scope and readership.
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