The Safety and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder

Summary

The Safety and Tolerability of COMP360 in Participants with Post-traumatic Stress Disorder

Timeline

Start

2022-06-10

Primary completion

2024-02-12

Completion

2024-02-12

Outcome

Met primary endpoint

release “in 22 patients with post-traumatic stress disorder (PTSD). The study met its primary safety endpoint and available secondary efficacy endpoints.” compasspathways.com ↗

Publications

• Dougherty RF, Modlin NL, McGowan NM, Staples P, Williams E, Clarke P, Shafiei M, Leininger C, Alti M, Croal M, Marwood L, Kirlic N, Ryslik GA, Goodwin GM. Silence is golden: Documenting the speech production of participants and support providers in psilocybin administration sessions for the treatment of post-traumatic stress disorder. J Psychopharmacol. 2026 Jul 16:2698811261464988. doi: 10.1177/02698811261464988. Online ahead of print.
• Modlin NL, Williamson V, Goodwin GM, Malievskaia E, Atli M, Elek Z, Gaillard A, Koelpin D, Cleare A, Agrawal M, Yehuda R, Kirlic N, Rucker J. Investigational psilocybin treatment for post-traumatic stress disorder: a qualitative study of participant experience, trauma engagement, and differences from standard treatment. EClinicalMedicine. 2025 Dec 5;90:103692. doi: 10.1016/j.eclinm.2025.103692. eCollection 2025 Dec.
• McGowan NM, Rucker JJ, Yehuda R, Agrawal M, Modlin NL, Simmons H, Tofil-Kaluza A, Das S, Goodwin GM. Investigating the safety and tolerability of single-dose psilocybin for post-traumatic stress disorder: A nonrandomized open-label clinical trial. J Psychopharmacol. 2026 Jan;40(1):139-148. doi: 10.1177/02698811251362390. Epub 2025 Aug 29.

Drugs

Indications