Psilocybin Therapy

"Psilocybin is a non-addictive classic psychedelic (22, 23) with neuroplasticity-inducing properties (24, 25). It is consistently ranked as one of the least harmful illicit psychoactive substances (4, 5), despite being among the most highly regulated substances globally. Psilocybin is a tryptamine alkaloid with serotonin 2A receptor (5-HT2A) agonism (26)—and complex pharmacology at many additional serotonin and non-serotonin receptors—that induces marked transitory changes in perception, cognition, and affect. Early phase clinical trials demonstrate that one to three moderate-to-high doses (20 mg to 30 mg/70 kg or more) of psilocybin combined with a brief course of psychotherapy (i.e., psilocybin-assisted psychotherapy) is safe, feasible, and preliminarily efficacious at alleviating symptoms of major depressive disorder, anxiety and depression associated with end-of-life diagnoses, and alcohol and tobacco use disorder (27–30). Psilocybin-assisted psychotherapy received a ‘Breakthrough Therapy’ designation from the United States Food and Drug Administration for both major depressive disorder and treatment-resistant depression. This designation was created to expedite the development and review of drugs intended to treat serious or life-threatening conditions for which preliminary evidence suggests substantial improvement over available options."