A Phase I trial to inform clinical protocols for the safe administration of psilocybin-assisted psychotherapy
medRxiv April 19, 2023 Jennifer Bennett, Michael D. Blough, Ian Mitchell et al. 3 citations preprint
In a Phase I trial, 14 healthy individuals received 25 mg of psilocybin extract. Transient, clinically insignificant rises in blood pressure and heart rate occurred, returning to normal as drug effects waned; all participants had normal two-month follow-ups. Mean peak systolic and diastolic blood pressures during the session were 145.93 (SD = 19.01) and 93.93 (SD = 9.75), a significant increase from baseline but tolerated by a healthy cardiovascular system. Focused screening protocols are suggested to balance safety and accessibility. Secondary outcomes showed a statistically significant decrease in QIDS-SR16 depression scores from baseline (M = 3.50, SD = 2.35) to eight-week follow-up (M = 1.86, SD = 0.86), and MEQ-30 scores indicated full mystical experiences.