Manzano-Nunez Ramiro, Gomez Diego A, Toledo-Mendoza Catalina, Perez-Otero Marta, Matilla Iris L, Prats Claudia, Perez-Lopez Elena, Pardo Helmuth, Díaz-Pellicer Patricia, De La Torre-Fornell Rafael, Aldea Ana M
Clinica Mi Tres Torres, Barcelona, Spain.
Department of Medical Oncology, Vall d'Hebron University Hospital, Barcelona, Spain.
Clin Neuropharmacol. 2025;48(1):13-19. doi: 10.1097/WNF.0000000000000617.
This scoping review aimed to synthesize the existing data about psilocybin pharmacokinetics to learn what has been described regarding body disposition and safety when psilocybin was used in controlled research settings.
We performed a scoping literature review following the framework proposed by the JBI manual for evidence synthesis. Controlled clinical trials reporting pharmacokinetic data of psilocybin were considered appropriate for inclusion. We extracted the data on psilocybin pharmacokinetics and summarized it from the available literature on this topic. We also performed an exploratory-descriptive analysis using study level data to examine the relationship between dose of psilocybin and maximum serum concentrations (Cmax).
We initially identified 850 articles, of which 5 were included. These trials included 112 healthy volunteers who received psilocybin in a controlled clinical setting. The peak concentration of psilocin in plasma (Cmax) ranged from 8.2 ng/mL to 37.2 ng/mL (median = 17, IQR = 11.9 to 23.5). The maximal concentrations (Cmax) of psilocin were reached (Tmax) around 2 hours, ranging from 1.7 hours to 2.2 hours (median = 2, IQR = 1.9 to 2.1) after psilocybin oral administration. Elimination half-life was between 1.2 hours and 3.3 hours (median = 2.0, IQR = 1.6 to 2.8). A strong positive relationship between dose and Cmax ( R2 = 0.95) was found. No serious adverse events were observed. We did not find studies reporting pharmacokinetic data from patients with depression or cancer patients transitioning to palliative care.
In summary, this review unveils oral psilocybin pharmacokinetics in healthy adults, revealing gaps in its application to target populations like those with depression or in palliative care.
本范围综述旨在综合有关裸盖菇素药代动力学的现有数据，以了解在对照研究环境中使用裸盖菇素时，关于其体内分布和安全性的描述。
我们按照JBI循证综合手册提出的框架进行了范围文献综述。报告裸盖菇素药代动力学数据的对照临床试验被认为适合纳入。我们提取了裸盖菇素药代动力学数据，并从该主题的现有文献中进行了总结。我们还使用研究水平的数据进行了探索性描述性分析，以检查裸盖菇素剂量与最大血清浓度（Cmax）之间的关系。
我们最初识别出850篇文章，其中5篇被纳入。这些试验包括112名在对照临床环境中接受裸盖菇素的健康志愿者。血浆中脱磷酸裸盖菇素的峰值浓度（Cmax）范围为8.2纳克/毫升至37.2纳克/毫升（中位数=17，四分位间距=11.9至23.5）。口服裸盖菇素后，脱磷酸裸盖菇素的最大浓度（Cmax）在约2小时时达到（达峰时间[Tmax]），范围为1.7小时至2.2小时（中位数=2，四分位间距=1.9至2.1）。消除半衰期在1.2小时至3.3小时之间（中位数=2.0，四分位间距=1.6至2.8）。发现剂量与Cmax之间存在强正相关（R2 = 0.95）。未观察到严重不良事件。我们未找到报告抑郁症患者或转向姑息治疗的癌症患者药代动力学数据的研究。
总之，本综述揭示了健康成年人口服裸盖菇素的药代动力学，揭示了其在抑郁症患者或姑息治疗等目标人群中的应用差距。
