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MDLSD:一项在健康志愿者中重复给予 LSD 微剂量的随机、双盲、安慰剂对照试验的研究方案。

MDLSD: study protocol for a randomised, double-masked, placebo-controlled trial of repeated microdoses of LSD in healthy volunteers.

机构信息

School of Pharmacy, Faculty of Medical and Health Sciences, University of Auckland, 85 Park Road, Grafton, Auckland, 1023, New Zealand.

Mana Health, 7 Ruskin St, Parnell, Auckland, 1052, New Zealand.

出版信息

Trials. 2021 Apr 23;22(1):302. doi: 10.1186/s13063-021-05243-3.

DOI:10.1186/s13063-021-05243-3
PMID:33892777
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8062934/
Abstract

BACKGROUND

Regular ingestion of sub-hallucinogenic doses of psychedelics, referred to as "microdosing", has gained increasing popularity and attention in the press and in online forums, with reported benefits across multiple cognitive and emotional domains. Rigorously controlled studies to date, however, have been limited in scope and have failed to produce results comparable to those reported in the grey literature.

METHODS

Eighty healthy male participants will receive 14 doses of placebo or 10 μg lysergic acid diethylamide orally every 3rd day over a 6-week treatment protocol. A battery of personality, creativity, mood, cognition, and EEG plasticity measures, as well as resting-state fMRI imaging, will be administered at baseline and at the end of the protocol. Creativity, mood, and plasticity measures will additionally be assessed in the acute phase of the first dose. Daily functioning will be monitored with questionnaires and a wearable sleep and activity tracker.

DISCUSSION

This study will rigorously examine the claims presented in the microdosing grey literature by pairing a comparable dosing protocol with objective measures. Potential therapeutic implications include future clinical trials to investigate microdosed psychedelics as a standalone treatment or as an augmentation of psychotherapy in the treatment of depression, addiction, eating disorders, obsessive-compulsive disorders, and palliative care.

TRIAL REGISTRATION

ACTRN12621000436875 . Registered on 19 February 2021.

摘要

背景

定期摄入低致幻剂量的迷幻剂,被称为“微量摄入”,在媒体和在线论坛上越来越受欢迎,据报道对多个认知和情绪领域都有好处。然而,迄今为止,严格控制的研究范围有限,并且未能产生与灰色文献中报告的结果相媲美的结果。

方法

80 名健康男性参与者将在 6 周的治疗方案中,每隔 3 天口服接受 14 次安慰剂或 10μg 麦角酸二乙酰胺。在基线和方案结束时,将进行一系列人格、创造力、情绪、认知和脑电图可塑性测量以及静息状态 fMRI 成像。在第一次剂量的急性阶段,还将评估创造力、情绪和可塑性测量。通过问卷和可穿戴睡眠和活动追踪器监测日常功能。

讨论

通过将类似的剂量方案与客观测量相结合,本研究将严格检查微量摄入灰色文献中的说法。潜在的治疗意义包括未来的临床试验,以研究微剂量迷幻剂作为单独治疗或作为抑郁症、成瘾、饮食障碍、强迫症和姑息治疗的心理治疗的增强剂。

试验注册

ACTRN12621000436875。于 2021 年 2 月 19 日注册。

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Positive expectations predict improved mental-health outcomes linked to psychedelic microdosing.积极的预期可预测与迷幻药微量使用相关的心理健康改善结果。
Sci Rep. 2021 Jan 21;11(1):1941. doi: 10.1038/s41598-021-81446-7.
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Psychopharmacology (Berl). 2025 Feb;242(2):337-351. doi: 10.1007/s00213-024-06680-z. Epub 2024 Sep 5.
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LSD increases sleep duration the night after microdosing.LSD 会增加微剂量使用后次日的睡眠时间。
Transl Psychiatry. 2024 Apr 15;14(1):191. doi: 10.1038/s41398-024-02900-4.
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PAM trial protocol: a randomised feasibility study of psychedelic microdosing-assisted meaning-centred psychotherapy in advanced stage cancer patients.PAM试验方案:晚期癌症患者使用迷幻微剂量辅助意义中心心理治疗的随机可行性研究。
Pilot Feasibility Stud. 2024 Feb 12;10(1):29. doi: 10.1186/s40814-024-01449-9.
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Modulation of long-term potentiation following microdoses of LSD captured by thalamo-cortical modelling in a randomised, controlled trial.在一项随机对照试验中,通过丘脑-皮质模型捕获的小剂量麦角酸二乙酰胺(LSD)对长期增强作用的调节。
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Henri Michaux's program for the psychedelic humanities.亨利·米肖的迷幻人文计划。
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Correction to: MDLSD: study protocol for a randomised, double-masked, placebo-controlled trial of repeated microdoses of LSD in healthy volunteers.对《MDLSD:健康志愿者重复微剂量LSD随机、双盲、安慰剂对照试验的研究方案》的勘误
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Twenty percent better with 20 micrograms? A qualitative study of psychedelic microdosing self-rapports and discussions on YouTube.提高 20%?对迷幻药微剂量自我报告和 YouTube 讨论的定性研究。
Harm Reduct J. 2019 Nov 28;16(1):63. doi: 10.1186/s12954-019-0333-3.
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Self-Rated Effectiveness of Microdosing With Psychedelics for Mental and Physical Health Problems Among Microdosers.微剂量服用迷幻剂对微剂量使用者身心健康问题的自评效果
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Acute Subjective and Behavioral Effects of Microdoses of Lysergic Acid Diethylamide in Healthy Human Volunteers.健康人体志愿者中低剂量麦角酸二乙酰胺的急性主观和行为效应。
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