Psilocybin for the Treatment of Veterans With Post-Traumatic Stress Disorder

Phase 2

Active, not recruiting

• Conditions: Trauma and Stressor Related Disorders; PTSD; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Mental Disorder
• Interventions: Drug: Psilocybin

• Registration Number: NCT05554094
• Lead Sponsor: Ohio State University

Brief Summary

The primary aim of this study is to assess the safety and efficacy of psilocybin-assisted therapy in the treatment of post-traumatic stress disorder in United States military Veterans.

Detailed Description

The objective of this study is to determine the safety and efficacy of psilocybin assisted psychotherapy in the treatment of Veterans with PTSD.

This study will recruit 15 United States Military Veterans, age 21 to 64, primarily from the Columbus and Central Ohio Region who meet the criteria for PTSD. After enrollment and informed consent, participants will receive two separate doses of psilocybin in conjunction with preparatory and post-psilocybin therapy sessions. Each psilocybin session will last approximately 8 hours and will be facilitated by two trained session facilitators. Before the first psilocybin session, participants will meet with one or both of the session facilitators for a total of 6-8 hours of contact time (or up to 4 meetings) before the first psilocybin session day. Two post psilocybin therapy session visits will follow Psilocybin Sessions 1 and 2. Psilocybin Sessions 1 and 2 will occur about two weeks apart. Follow-up visits will occur 1 and 2 weeks and 1, 3, and 6 months after the final psilocybin session, with additional contact hours scheduled as needed. Thus, the intervention and follow-up requires at least 13 visits over a period of about 8-10 months.

Study Timeline

• Study First Submitted: 2022-09-21
• Study First Submitted QC: 2022-09-21
• Study First Posted: 2022-09-26
• Study Start: 2023-01-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-06
• Primary Completion: 2025-08-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

• Current or past history of schizophrenia or other psychotic disorders or Bipolar I or II Disorder
• Current or history within one year of a moderate or severe alcohol, tobacco, or other drug use disorder
• Have a first or second-degree relative with schizophrenia spectrum or other psychotic disorders or Bipolar I or II Disorder
• Has a psychiatric condition which precludes the establishment of therapeutic rapport
• History of a medically significant suicide attempt
• Current antidepressant use

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Psilocybin-assisted therapy	Psilocybin	Participants will receive two doses of psilocybin, approximately 2 weeks apart, in conjunction with preparatory and post-psilocybin therapy sessions

Primary Outcome Measures

Name	Time	Method
Type, severity, and frequency of Adverse Events (AEs) associated with psilocybin assisted therapy	Baseline to Primary Endpoint (1 month post psilocybin session 2)	The primary clinician/session facilitator for each participant will identify/record adverse effects (i.e. the emergence of any untoward physical or psychological events or symptoms) and safety concerns at each study visit. The type, severity, and frequency of adverse events will be collected in order to identify and characterize any safety concerns that may arise. Relationship to study drug will also be reported
Columbia Suicide Severity Rating Scale (C-SSRS)	Baseline to Primary Endpoint (1 month post psilocybin session 2)	The C-SSRS is divided into four subscales based on 1) severity of ideation 2) intensity of ideation 3) suicidal behavior, and 4) lethality of attempt. Severity of ideation scores will be assessed for significant changes from baseline to primary endpoint. Proportion of participants meeting criteria for low, medium, and high risk will be reported.

Secondary Outcome Measures

Name	Time	Method
PTSD Symptom Severity as measured by the Clinician Administered PTSD Scale-5 (CAPS-5)	Baseline to Primary Endpoint (1 month post psilocybin session 2)	The CAPS-5 is a 30-item structured-interview that assesses PTSD diagnostic status and symptom severity. It is scored on a scale of 0-80 with higher scores indicating greater symptom severity.
PTSD Checklist for Diagnostic and Statistical Manual Diploma in Social Medicine-5 (PCL-5)	Baseline to Primary Endpoint (1 month post psilocybin session 2)	The PCL-5 is one of the most widely used self-report measures of PTSD with scores ranging from 0 to 80 and higher scores indicating greater PTSD symptom severity.

Trial Locations

Locations (1)

Ohio State University Department of Psychiatry and Behavioral Health at the Davis Medical Research Center; 🇺🇸 Columbus, Ohio, United States