Psilocybin for PTSD with or without Psychotherapy: A Pilot study of safety and efficacy outcomes – The first characterization of nightmare burden in PTSD following psilocybin administration

Abstract

This nightmare-focused study was conducted based on data collected in an open-label, controlled treatment pilot trial conducted at the Johns Hopkins Center for Psychedelic and Consciousness Research (CPCR) under an approved protocol (IRB00407008; NCT06407635). Participants completed screening, baseline assessment, four preparatory sessions, two psilocybin dosing sessions, seven post-session integration visits, and follow-up assessments. The intervention consisted of 8 hours of preparatory meetings (over approximately 2 weeks), followed by 2 psilocybin sessions separated by approximately 2 weeks. Participants received 25 mg in the first session. The participant was given the option of increasing to 35 mg for the second dose. Otherwise, the dose on the first and second session was 25 mg. Eighteen participants completed nightmare-related assessments.

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