Safety and Tolerability of Psilocybin in Post-Traumatic Stress Disorder

Phase 1 Withdrawn Johns Hopkins University

Non-randomizedSequentialOpen-labelTreatment

Summary

The purpose of this study is to evaluate the safety, tolerability, and potential efficacy of psilocybin-assisted psychotherapy to reduce post-traumatic stress disorder (PTSD) severity in a sample of individuals with PTSD.

Timeline

Start: 2025-01
Primary completion: 2025-12
Completion: 2025-12

Outcome

Outcome not reported

Stopped: “The principal investigator will be at a new institution.”

Publications

Background Griffiths RR, Johnson MW, Carducci MA, Umbricht A, Richards WA, Richards BD, Cosimano MP, Klinedinst MA. Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer: A randomized double-blind trial. J Psychopharmacol. 2016 Dec;30(12):1181-1197. doi: 10.1177/0269881116675513.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Psilocybin	Other / unclassified	15 mg	—
Subject	Psilocybin	Other / unclassified	20 mg	—
Subject	Psilocybin	Other / unclassified	25 mg	—
Subject	Psilocybin	Other / unclassified	30 mg	—
Subject	Psilocybin	Other / unclassified	35 mg	—
Subject	Psilocybin	Other / unclassified	40 mg	—
Subject	Psilocybin	Other / unclassified	45 mg	—