Exposure-Response Analysis to Assess the Concentration-QTc Relationship of Psilocybin/Psilocin
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2022;10(12):24 Clin Pharmacol Drug Dev. 2021 11-Apr;():. 10.1002/cpdd.796What this means for my practice?
Despite a significant concentration-QTc relationship, there is a limited potential of QT prolongation following a 25mg psilocybin dose, while QTcF prolongation was characterized at doses 2 times higher than 25mg.
Study Summary
In a prospective, ascending dose study of psilocybin 12 participants took four different doses of psilocybin (19-22mg/kg BW; 26-31mg/kg BW; 32-41mg/kg BW; 42-59mg/kg BW) separated by 4 weeks between doses. Biochemical analysis of serum psilocin and vitals were taken at each session. A significant but shallow concentration-QTc relationship was seen, with a clinical dose of 25mg showing a mean QTcF change of 2.1ms. The upper limit of the 90% confidence interval of the model predicted a mean deltaQTcF crossing 10ms at a concentration of 31.1ng/mL.
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