Straumann Isabelle, Holze Friederike, Becker Anna M, Ley Laura, Halter Nepomuk, Liechti Matthias E
Division of Clinical Pharmacology and Toxicology, Department of Biomedicine and Department of Clinical Research, University Hospital Basel and University of Basel, Basel, Switzerland.
Department of Pharmaceutical Sciences, University of Basel, Basel, Switzerland.
Neurosci Appl. 2024 Mar 16;3:104060. doi: 10.1016/j.nsa.2024.104060. eCollection 2024.
Psilocybin is being studied for its therapeutic potential in various mental health disorders, such as depression, anxiety, and addiction. Initial studies suggested that psilocybin is generally safe when used under controlled conditions, but more research is needed to better understand its safety profile. We report safety pharmacology data from a pooled analysis of three randomized crossover studies that included 85 healthy participants and 113 single-dose administrations of psilocybin. Single oral doses included 15 mg, 20 mg, 25 mg, and 30 mg psilocybin dihydrate. We investigated subjective effects, blood pressure, heart rate, body temperature, acute and subacute adverse effects, reports of flashbacks, and liver and kidney function before and after the studies. The 20, 25, and 30 mg doses of psilocybin produced stronger effects than the 15 mg dose. Psilocybin at all doses induced higher "good drug effects" than "bad drug effects." Only the 25 and 30 mg doses increased anxiety. Psilocybin elevated autonomic effects only moderately. Tachycardia (>100 beats/min) was observed with 7% of all psilocybin administrations. Body temperature >38° was reached in 7%, 9%, 17%, and 32% of the participants with the 15, 20, 25, and 30 mg doses, respectively. Kidney and liver function parameters were unaltered at the end of the study. Five participants (6%) reported transient flashback phenomena. No serious adverse reactions occurred. These findings suggest that a single administration of psilocybin is safe with regard to acute psychological and physical harm in healthy participants in a controlled research setting.
裸盖菇素正在针对其在各种精神健康障碍（如抑郁症、焦虑症和成瘾）中的治疗潜力进行研究。初步研究表明，裸盖菇素在受控条件下使用时通常是安全的，但需要更多研究来更好地了解其安全性。我们报告了三项随机交叉研究的汇总分析得出的安全药理学数据，这些研究包括85名健康参与者和113次裸盖菇素单剂量给药。口服单剂量包括15毫克、20毫克、25毫克和30毫克的裸盖菇素二水合物。我们在研究前后调查了主观效应、血压、心率、体温、急性和亚急性不良反应、闪回报告以及肝肾功能。20毫克、25毫克和30毫克剂量的裸盖菇素产生的效应比15毫克剂量更强。所有剂量的裸盖菇素产生的“良好药物效应”均高于“不良药物效应”。只有25毫克和30毫克剂量会增加焦虑。裸盖菇素仅适度提高自主神经效应。在所有裸盖菇素给药中，7%出现心动过速（>100次/分钟）。分别有7%、9%、17%和32%接受15毫克、20毫克、25毫克和30毫克剂量的参与者体温超过38°。研究结束时，肾和肝功能参数未发生改变。五名参与者（6%）报告了短暂的闪回现象。未发生严重不良反应。这些发现表明，在受控研究环境中，对于健康参与者的急性心理和身体伤害而言，单次给予裸盖菇素是安全的。
