Healthy VolunteersSubstance Use Disorders (SUD)Medicinal Chemistry & Drug DevelopmentPsilocybin

High dose psilocybin is associated with positive subjective effects in healthy volunteers

In a within-subject study of 12 healthy volunteers given three escalating oral psilocybin doses (0.3–0.6 mg/kg), higher doses produced greater Mystical Experience Questionnaire scores—particularly on the transcendence of time and space subscale—and positive persisting effects 30 days later. Pharmacokinetics scaled with dose but did not predict mystical scores, and a complete mystical experience was not necessary for positive outcomes.

Authors

  • Christopher Nicholas
  • Nicholas Cozzi
  • Paul Hutson

Published

Journal of Psychopharmacology
individual Study

Abstract

Aim

The aim of the current study was to investigate the relationship between escalating higher doses of psilocybin and the potential psilocybin occasioned positive subjective effects.

Methods

Healthy participants ( n=12) were given three escalating doses of oral psilocybin (0.3 mg/kg; 0.45 mg/kg; 0.6 mg/kg) or (18.8–36.6 mg; 27.1–54.0 mg; 36.3–59.2 mg) a minimum of four weeks apart in a supervised setting. Blood and urine samples, vital signs, and electrocardiograms were obtained. Subjective effects were assessed using the Mystical Experience Questionnaire and Persisting Effects Questionnaire.

Results

There was a significant linear dose-related response in Mystical Experience Questionnaire total score and the transcendence of time and space subscale, but not in the rate of a complete mystical experience. There was also a significant difference between dose 3 compared to dose 1 on the transcendence of time and space subscale, while no dose-related differences were found for Mystical Experience Questionnaire total scores or rate of a mystical experience. Persisting Effects Questionnaire positive composite scores 30 days after completion of the last dose were significantly higher than negative composite scores. Persisting Effects Questionnaire results revealed a moderate increase in sense of well-being or life satisfaction on average that was associated with the maximum Mystical Experience Questionnaire total score. Pharmacokinetic measures were associated with dose but not with Mystical Experience Questionnaire total scores or rate of a mystical experience.

Conclusions

High doses of psilocybin elicited subjective effects at least as strong as the lower doses and resulted in positive persisting subjective effects 30 days after, indicating that a complete mystical experience was not a prerequisite for positive outcomes.

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Research Summary of 'High dose psilocybin is associated with positive subjective effects in healthy volunteers'

Introduction

Psilocybin is a classical psychedelic compound reported to produce intense alterations in perception, mood and sense of self, and in some people to occasion a so-called mystical or spiritual experience characterised by unity, sacredness, ineffability and transcendence of time and space. Early clinical and experimental work suggests that psilocybin can produce lasting positive psychological effects and improvements in mood and substance use outcomes when administered in supportive settings. Most contemporary human studies, however, have used a relatively narrow dose range (about 20–30 mg per 70 kg, roughly 0.28–0.43 mg/kg), leaving uncertainty about subjective and persisting effects at higher doses and whether a full mystical experience is necessary for beneficial outcomes. Nicholas and colleagues set out to examine the relationship between escalating, higher oral doses of psilocybin and acute and persisting positive subjective effects in healthy volunteers. The primary aim reported here was to relate dose and pharmacokinetic measures to scores on the Mystical Experience Questionnaire (MEQ30) and on the Persisting Effects Questionnaire (PEQ) collected up to 30 days after the last dose; the data derive from an open-label Phase I study that also characterised pharmacokinetics and safety of weight‑based dose escalation up to 0.60 mg/kg.

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Study Details

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