Cited by 96Psychedelics and Drug StudiesTreatment of Major DepressionReligion, Spirituality, and Psychology

Optimal dosing for psilocybin pharmacotherapy: Considering weight-adjusted and fixed dosing approaches

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Garcia-Romeu, Albert, Barrett, Frederick S, Carbonaro, Theresa M, Johnson, Matthew W, Griffiths, Roland R·2021·Journal of Psychopharmacology

Abstract

Background: Growing evidence suggests psilocybin, a naturally occurring psychedelic, is a safe and promising pharmacotherapy for treatment of mood and substance use disorders when administered as part of a structured intervention. In most trials to date, psilocybin dose has been administered on a weight-adjusted basis rather than the more convenient procedure of administering a fixed dose. Aims: The present post hoc analyses sought to determine whether the subjective effects of psilocybin are affected by body weight when psilocybin is administered on a weight-adjusted basis and when psilocybin is administered as a fixed dose. Methods: We analyzed acute subjective drug effects (mystical, challenging, and intensity) associated with therapeutic outcomes from ten previous studies (total N = 288) in which psilocybin was administered in the range 20 to 30 mg/70 kg (inclusive). Separate multivariate regression analyses examined the relationships between demographic variables including body weight and subjective effects in participants receiving 20 mg/70 kg ( n = 120), participants receiving 30 mg/70 kg ( n = 182), and participants whose weight-adjusted dose was about 25 mg (to approximate the fixed dose that is currently being evaluated in registration trials for major depressive disorder) ( n = 103). Results: In the 20 mg/70 kg and 30 mg/70 kg weight-adjusted groups, and in the fixed dose group, no significant associations were found between subjective effects and demographic variables including body weight or sex. Across a wide range of body weights (49 to 113 kg) the present results showed no evidence that body weight affected subjective effects of psilocybin. Conclusions: These results suggest that the convenience and lower cost of administering psilocybin as a fixed dose outweigh any potential advantage of weight-adjusted dosing.

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Authors
Garcia-Romeu, A., Barrett, F. S., Carbonaro, T. M., Johnson, M. W., & Griffiths, R. R.
Affiliations
  • Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, USA
  • Johns Hopkins University (US)
Venue
Journal of Psychopharmacology
Published
2021-02-20
Volume
35
Issue
4
Pages
353-361
ISSN
  • 0269-8811 (ISSN-L)
  • 1461-7285
OpenAlex
W3129221857
Cited by
96
References
41
Citations by year
2026: 10 · 2025: 22 · 2024: 19 · 2023: 21 · 2022: 16 · 2021: 8
FWCI
10.91
Type
journal article
Language
en
Open access
Locations
  • Journal of Psychopharmacology (publishedVersion, cc-by-nc)
  • PubMed Central (publishedVersion, cc-by-nc)
  • PubMed (publishedVersion)
Funders
National Institute on Drug Abuse (R01DA003889)
Topics
  • Social Sciences › Psychology › Clinical Psychology › Psychedelics and Drug Studies
  • Health Sciences › Medicine › Pharmacology › Treatment of Major Depression
  • Social Sciences › Health › Religion, Spirituality, and Psychology
Keywords
psilocybin, dosage, weight-based dosing, fixed dose, body weight, subjective drug effects, mystical experience, major depressive disorder, mood disorders, substance use disorders
MeSH terms
Cigarette Smoking, Psychosocial Functioning, Adult, Affect, Body Weight, Major Depressive Disorder, Depressive Disorder, Major, Fear, Female, Grief, Hallucinogens, Humans, Male, Mysticism, Neoplasms, Psilocybin, Self-Assessment, Self Concept, Sex Factors, Treatment Outcome, Drug Monitoring, Drug Dosage Calculations, Serotonin 5-HT2 Receptor Agonists

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