NCT05562973

Safety and Tolerability of Psilocybin in Post-Traumatic Stress Disorder

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Post-Traumatic Stress Disorder

Interventions

Type	Name	Description
DRUG	Psilocybin	Participants will receive three psilocybin sessions, at least two weeks apart.

Timeline

• Start date: 2025-01-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2022-10-03
• Last updated: 2024-01-05

Regulatory

• FDA-regulated drug study