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Study protocol of an open-label proof-of-concept trial examining the safety and clinical efficacy of psilocybin-assisted therapy for veterans with PTSD

Alan K. Davis, Adam W. Levin, Paul Nagib, Stacey B. Armstrong, Rafaelle Lancelotta

BMJ Open May 1, 2023 DOI: 10.1136/bmjopen-2022-068884 (opens in new tab)

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Study at a glance

AI-extracted from the abstract
Characteristics Open-label pilot study Peer reviewed
Sample size 15
Population U.S. military veterans with severe, treatment-resistant PTSD
Intervention Psilocybin-assisted therapy
Dose 15 mg and 25 mg
Duration 1-month primary endpoint; 6-month total follow-up
Topics Psychedelic-assisted therapy Psilocybin PTSD
Keywords Adult psychiatry Clinical pharmacology Clinical trials Mental health treatment Veterans healthcare Clinical research PTSD Treatment
Citations 19
Registration NCT05554094
Key points The study will examine the safety and efficacy of two psilocybin administration sessions combined with psychotherapy in U.S. military veterans with severe, treatment-resistant PTSD.

Abstract

Introduction Psilocybin-assisted therapy has shown significant promise in treating the cluster of mood and anxiety symptoms that comprise post-traumatic stress disorder (PTSD) but has yet to be tested specifically in this condition. Furthermore, current pharmacological and psychotherapeutic treatments for PTSD are difficult to tolerate and limited in efficacy, especially in the US Military Veteran (USMV) population. This open-label pilot study will examine the safety and efficacy of two psilocybin administration sessions (15 mg and 25 mg), combined with psychotherapy, among USMVs with severe, treatment resistant PTSD. Methods and analysis We will recruit 15 USMVs with severe, treatment resistant PTSD. Participants will receive one low dose (15 mg) and one moderate/high dose (25 mg) of psilocybin in conjunction with preparatory and post-psilocybin therapy sessions. The primary safety outcome will be the type, severity and frequency of adverse events and suicidal ideation/behaviour, as measured by the Columbia Suicide Severity Rating Scale. The primary outcome measure for PTSD will be the Clinician Administered PTSD Scale-5. The primary endpoint will be 1 month following the second psilocybin administration session, and the total follow-up time will be 6 months. Ethics and dissemination All participants will be required to provide written informed consent. The trial has been authorised by the Ohio State University Institutional Review Board (study number: 2022H0280). Dissemination of results will occur via a peer-reviewed publication and other relevant media. Trial registration number NCT05554094 .

In the evidence

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

  • State of the evidence: Psilocybin for PTSD Unclear

    Describes a planned open-label trial of two psilocybin sessions (15 mg and 25 mg) with psychotherapy, with safety and CAPS-5 outcomes at one month and follow-up to six months.

    Synthesized

Comparable studies

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

Study Year Design Participants
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
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 Participants in a psilocybin treatment pilot trial who completed nightmare-related... 2026 Open-label controlled pilot trial n = 18
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

Citations in the library

Cited by 18

and 13 more in the library

Cites 18

and 13 more in the library

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Psilocybin and psychedelic-assisted therapy Psilocybin for PTSD