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Safety and Tolerability of Psilocybin in Post-Traumatic Stress Disorder

Post-Traumatic Stress Disorder Clinical Trial

Official title:
Safety and Tolerability of Psilocybin in Post-Traumatic Stress Disorder

Clinical Trial 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.

Clinical Trial Description

The proposed Phase I study aims to evaluate the safety, tolerability, and potential efficacy of psilocybin-assisted psychotherapy to reduce PTSD severity in a sample of individuals with PTSD. A sample of up to 30 individuals with PTSD will be recruited. All participants will receive the intervention, which will consist of three psilocybin sessions with an interval of approximately 2 weeks between each session. A 3+3 Phase I trial design will be used to evaluate a range of possible dose sequences with doses ranging from 15 mg up to 45 mg. Safety, tolerability, and efficacy endpoints will be evaluated 2 weeks following each psilocybin session and at 1-month, 3-month, and 6-month follow-ups. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05562973
Study type Interventional
Source Johns Hopkins University
Contact
Status Withdrawn
Phase Phase 1
Start date January 2025
Completion date December 2025
View Details
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