Klaiber Aaron, Humbert-Droz Mélusine, Ley Laura, Schmid Yasmin, Liechti Matthias E
Division of Clinical Pharmacology and Toxicology, University Hospital Basel, Basel, Switzerland.
Department of Biomedicine, University of Basel, Basel, Switzerland.
Br J Clin Pharmacol. 2024 Nov 25. doi: 10.1111/bcp.16349.
Psychedelics, including mescaline, may serve as novel treatments for depression and anxiety. However, data is scarce on the safety of mescaline.
The present pooled analysis included two double-blind, randomized, placebo-controlled studies with a total of 48 participants and 96 mescaline administrations. Single oral-dose administrations (n = 16/dose) of mescaline at doses of 100-800 mg were used. Acute subjective and autonomic effects and acute and subacute adverse effects were recorded. Liver and kidney function, blood cell counts, and "flashbacks" were documented at the end of the studies.
Positive subjective effects dose-dependently increased and were higher than negative subjective effects for all mescaline doses. Autonomic effects increased moderately. Systolic blood pressure remained < 180 mmHg in all participants. Of all mescaline administrations, diastolic blood pressure > 100 mmHg was measured in 6%, heart rate > 100 beats/min was measured in 3% and body temperature > 38 °C was measured in 5%. The total number of acute adverse effects was 51, 12, 179, 143, 165 and 180 at 100, 200, 300, 400, 500 and 800 mg doses of mescaline, respectively. Nausea was dose-limiting. Kidney and liver function and blood cell counts remained normal. "Flashbacks" were reported after 2% of all mescaline administrations.
These findings suggest that the administration of single mescaline doses up to 800 mg are safe in a controlled clinical setting with regard to acute psychological and physical harm in healthy participants.
包括三甲氧苯乙胺在内的致幻剂可能成为治疗抑郁症和焦虑症的新方法。然而，关于三甲氧苯乙胺安全性的数据却很匮乏。
本汇总分析纳入了两项双盲、随机、安慰剂对照研究，共有48名参与者，进行了96次三甲氧苯乙胺给药。使用了100 - 800毫克剂量的三甲氧苯乙胺单次口服给药（每次剂量n = 16）。记录了急性主观和自主神经效应以及急性和亚急性不良反应。在研究结束时记录了肝肾功能、血细胞计数和“闪回”情况。
积极的主观效应呈剂量依赖性增加，且在所有三甲氧苯乙胺剂量下均高于消极的主观效应。自主神经效应适度增加。所有参与者的收缩压均保持在<180毫米汞柱。在所有三甲氧苯乙胺给药中，舒张压>100毫米汞柱的占6%，心率>100次/分钟的占3%，体温>38°C的占5%。在100、200、300、400、500和800毫克剂量的三甲氧苯乙胺给药中，急性不良反应的总数分别为51、12、179、143、165和180例。恶心是剂量限制性的。肝肾功能和血细胞计数保持正常。在所有三甲氧苯乙胺给药中有2%出现了“闪回”报告。
这些研究结果表明，在可控的临床环境中，对于健康参与者而言，单次给予高达800毫克的三甲氧苯乙胺在急性心理和身体伤害方面是安全的。
