A Proposal to Study the Safety and Efficacy of Psilocybe cubensis in Preclinical and Clinical Studies as a Therapeutic Alternative for Major Depressive Disorder
Journal of Psychoactive Drugs August 18, 2023 Raul Escamilla, María Eva González-Trujano, Jesús M González Mariscal et al. 7 citations
Psilocybin, a natural alkaloid in Psilocybe mushrooms endemic to Mexico, represents a novel and breakthrough therapy for major depression. Current antidepressant treatments require prolonged use with modest effects, adverse effects, and relapse upon discontinuation. This report presents a research project design that includes preclinical toxicity and pharmacological evaluation of a Psilocybe cubensis extract in mice, chemical analysis of the mushroom's constituents, and a clinical study. The clinical component will assess safety and tolerated doses in healthy adults via pharmacokinetic measurements, followed by an open trial in patients with major depressive disorder comparing two single doses of Psilocybe cubensis with assisted psychotherapy to traditional care at a Mexican institute.