Evidence Base

Clinical Trials in Psychedelic Medicine

The landmark studies establishing psilocybin and MDMA as breakthrough psychiatric treatments — sorted by condition, sponsor, and result.

2022
Phase 2b Complete — Phase 3 Ongoing

COMPASS Pathways COMP360 Phase 2b — Treatment-Resistant Depression

Sponsor: COMPASS Pathways n = 233 Condition: Treatment-Resistant Depression (TRD)
29% remission rate with 25mg vs. 8% placebo at week 3
2020
Completed

Johns Hopkins — Psilocybin for Major Depression

Sponsor: Johns Hopkins University n = 24 Condition: Major Depressive Disorder
71% showed clinically significant response; 54% in remission at 4-week follow-up
2021
Completed

Imperial College London — Psilocybin vs. Escitalopram (SSRI)

Sponsor: Imperial College London n = 59 Condition: Major Depressive Disorder
Psilocybin non-inferior to escitalopram on primary outcome; superior on secondary measures of well-being
2022
Completed

NYU — Psilocybin for Alcohol Use Disorder

Sponsor: NYU Langone Health (Bogenschutz et al.) n = 93 Condition: Alcohol Use Disorder
83% reduction in heavy drinking days vs. 51% placebo at 32 weeks; 48% total abstinence at 8 months
2014
Completed — Phase 2 RCT ongoing

Johns Hopkins — Psilocybin for Smoking Cessation

Sponsor: Johns Hopkins University (Matthew Johnson et al.) n = 15 Condition: Nicotine Use Disorder
67% abstinence at 12-month follow-up — significantly exceeding standard treatment (~35%)
2016
Completed

Johns Hopkins + NYU — Psilocybin for Cancer-Related Distress

Sponsor: Johns Hopkins / NYU (Griffiths, Ross et al.) n = 80 Condition: Cancer-related depression and existential anxiety
60-80% showed clinically significant reductions in anxiety and depression at 6 months
2023
Phase 3 Complete — FDA NDA under review (2024)

MAPS — MDMA-Assisted Therapy for PTSD (Phase 3)

Sponsor: MAPS (Multidisciplinary Association for Psychedelic Studies) n = 90 Condition: Post-Traumatic Stress Disorder (PTSD)
67-71% no longer met PTSD diagnostic criteria post-treatment vs. 32-48% placebo