在迷幻研究中对研究设计和安慰剂控制进行系统审查
Alexander Wen1, Nikhita Singhal2, Brett D M Jones2,3
1Department of Psychiatry, University of California San Diego, La Jolla, California, USA.
Psychedelic medicine (New Rochelle, N.Y.)
|March 7, 2025
概括
在迷幻随机对照试验 (RCT) 中,由于意识的改变,盲目化很困难. 这次审查建议使用活性安慰剂和剂量反应设计来改善盲目化并减少迷幻研究中的偏见.
科学领域:
- 心理药理学 心理药理学
- 临床试验方法论 临床试验方法论
- 神经科学是一个神经科学.
背景情况:
- 涉及迷幻药物的随机对照试验 (RCT) 在保持有效的参与者失明方面面临重大挑战.
- 经典迷幻药的固有精神活性效应会导致盲目化,可能会在研究结果中引入偏见.
- 对现有方法的系统审查和探索性分析对于理解和减轻这些挑战至关重要.
研究的目的:
- 综合用于经典迷幻药物的随机对照试验 (RCT) 的方法.
- 为了确定具体的程序,可以尽量减少揭开盲目和减少偏见在迷幻研究.
- 为改善未来迷幻药物临床试验的完整性提供基于证据的建议.
主要方法:
- 对涉及古典迷幻药和安慰剂的潜在RCT进行了全面的文献搜索,这些RCT在1963年至2023年1月之间发表.
- 包括的研究被系统地审查,以提取关于盲目的程序,研究设计和安慰剂类型的信息.
- 分析了48项临床试验的数据,包括50篇论文.
主要成果:
- 大多数包含的研究 (34/48) 是双盲的,大多数 (32/48) 使用了主体内部设计.
- 惰性安慰剂是常见的 (35/48研究),但盲目的完整性往往没有报告 (34/48研究).
- 当评估盲目的完整性时,经常发现它没有成功,这表明了重要的方法限制.
结论:
- 目前在迷幻实验中使用的试验方法往往无法保持有效的失明.
- 积极的安慰剂和剂量反应或积极的比较器设计被提议作为增强盲目和减轻预期效应的策略.
- 实施这些改进的设计对于提高迷幻研究结果的可靠性和有效性至关重要.
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