Psilocybin Research: The Complete Timeline of Clinical Trials
From the 1950s to the 2024 FDA advisory committee meeting — a complete timeline of psilocybin research and the key findings that are reshaping psychiatry.
The Short Answer
Psilocybin research has a 70-year history interrupted by a 30-year prohibition. The modern research era began in 2000 when Johns Hopkins received FDA approval for the first human psilocybin study in decades. Since then, over 100 clinical trials have been completed or are underway. The FDA granted Breakthrough Therapy designation for psilocybin in treatment-resistant depression in 2018. An FDA advisory committee reviewed MDMA-assisted therapy in 2024 — the decision will set precedent for psilocybin approval.
The Research Timeline
1950s–1960s: Albert Hofmann synthesizes psilocybin (1958). Hundreds of studies conducted on therapeutic applications. Timothy Leary's Harvard Psilocybin Project (1960–1962).
1970: Controlled Substances Act classifies psilocybin as Schedule I. Research effectively halted for 30 years.
2000: Johns Hopkins receives FDA approval for first modern human psilocybin study.
2006: Griffiths et al. publish landmark Psychopharmacology study showing psilocybin produces mystical experiences with lasting positive effects in healthy volunteers.
2014: Johnson et al. (Johns Hopkins) publish smoking cessation pilot: 80% abstinence at 6 months.
2016: Simultaneous Johns Hopkins and NYU trials show psilocybin reduces end-of-life anxiety in cancer patients.
2018: FDA grants Breakthrough Therapy designation for psilocybin in treatment-resistant depression.
2020: Oregon voters pass Measure 109, legalizing supervised psilocybin therapy.
2021: COMPASS Pathways Phase 2b trial (233 patients) shows significant depression reduction. Davis et al. (Johns Hopkins) publish major depression RCT: 71% response, 54% remission.
2022: MAPS MDMA trial published in Nature Medicine. Psilocybin trials for alcohol use disorder published in JAMA Psychiatry.
2024: FDA advisory committee reviews MDMA-assisted therapy — decision will set regulatory precedent for psilocybin.
This article is for informational purposes only and does not constitute medical advice.
This article is for informational purposes only and does not constitute medical advice. These statements have not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease. Consult your physician before making any changes to your health regimen.