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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

Zarmeen Zahid, Brandon Weiss, Sandeep Manel Nayak

2026 preprint DOI: 10.17605/osf.io/zkemp (opens in new tab)

Study at a glance

AI-extracted from the abstract
Characteristics Open-label controlled pilot trial Pilot study
Sample size 18
Population Participants in a psilocybin treatment pilot trial who completed nightmare-related assessments
Intervention Psilocybin
Dose 25 mg first session; option to increase to 35 mg for second session, otherwise 25 mg
Duration 8 hours of preparatory meetings over approximately 2 weeks, two psilocybin sessions separated by approximately 2 weeks, seven post-session integration visits, and follow-up assessments
Topics Dreaming Psilocybin PTSD
Registration NCT06407635
Key findings The abstract reports the design and dosing schedule of a nightmare-focused analysis within an open-label psilocybin pilot trial but does not present any nightmare-related results or conclusions.

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.

In the evidence

This study is part of the evidence base for a synthesis in the library. Here is how each one recorded it.

  • Reports the design and dosing schedule (25 mg, optional 35 mg second session) of a nightmare-focused analysis but presents no nightmare-related results.

    Synthesized

Comparable studies

Other non-randomized and open-label trials on psilocybin for PTSD, most cited first.

Study Year Design Participants
Study protocol of an open-label proof-of-concept trial examining the safety and clinical efficacy of psilocybin-assisted therapy for veterans with PTSD U.S. military veterans with severe, treatment-resistant PTSD 2023 Open-label pilot study n = 15
Investigating the safety and tolerability of single-dose psilocybin for post-traumatic stress disorder: A nonrandomized open-label clinical trial Adults with PTSD 2025 Phase 2, nonrandomized, open-label, multicenter trial n = 22
Psilocybin-assisted massed cognitive processing therapy for chronic posttraumatic stress disorder: Protocol for an open-label pilot feasibility trial Patients with chronic PTSD 2025 Open-label pilot study n = 15
Investigational psilocybin treatment for post-traumatic stress disorder: a qualitative study of participant experience, trauma engagement, and differences from standard treatment. Adults aged 18 or older with PTSD secondary to a traumatic event experienced in adulthood 2025 Qualitative study nested within an open-label phase 2 trial n = 21
Safety, feasibility, and preliminary clinical outcomes of psilocybin-assisted therapy for veterans with severe, treatment-resistant PTSD: an open-label pilot clinical trial. U.S. military Veterans aged 21-64 with severe, treatment-resistant PTSD 2026 Open-label pilot trial n = 12

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