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)
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.
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Describes a protocol to examine safety and efficacy of two psilocybin sessions (15 mg and 25 mg) with psychotherapy in veterans with severe, treatment-resistant PTSD.
Synthesized
Comparable studies
Other non-randomized and open-label trials on psilocybin for PTSD, most cited first.