🔬 Therapeutic Research

Clinical evidence and the path forward

Depression

Psilocybin therapy has shown large effect sizes in trials for treatment-resistant depression. Imperial College London's 2016 open-label study and Johns Hopkins' 2020 randomized controlled trial both found rapid and sustained reductions in depression severity. The COMPASS Pathways Phase 2b trial (2022) tested a single 25mg dose and found significant improvement, though with some adverse effects at higher doses.

PTSD

MAPS' Phase 3 trials of MDMA-assisted therapy for severe PTSD showed that approximately two-thirds of participants no longer met PTSD diagnostic criteria after treatment. The FDA declined to approve in 2024, citing concerns about functional unblinding and trial methodology, but the underlying clinical signal remains strong. Additional trials are underway.

Addiction

Psilocybin-assisted therapy has shown striking results for smoking cessation (Johns Hopkins — 80% abstinence at 6 months in the pilot study, a rate far exceeding standard treatments). NYU and others have studied psilocybin for alcohol use disorder with promising results. The model typically involves preparatory sessions, 1–3 dosing sessions, and integration therapy.

End-of-Life Distress

Some of the most emotionally powerful data: psilocybin produces rapid, large, and sustained reductions in anxiety and depression in patients with life-threatening cancer diagnoses. Both Johns Hopkins and NYU published landmark studies in 2016. Approximately 80% of participants showed clinically significant improvement sustained at 6-month follow-up.

The Therapeutic Model

Psychedelic-assisted therapy is not "take a pill daily." The model involves extensive preparation, a guided session in a supportive environment, and follow-up integration. The substance is a catalyst within a therapeutic container — not a standalone drug. This distinction matters for regulation, pricing, and access.