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

March 13, 2024 updated by: Alan K. Davis, Ohio State University

Examining the Safety and Clinical Efficacy of Psilocybin Therapy for Veterans With PTSD: An Open-Label Proof-of-Concept Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

15

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio State University Department of Psychiatry and Behavioral Health at the Davis Medical Research Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Description

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

  • A US military Veteran
  • 21 to 64 years old
  • Have at least a high-school level of education or equivalent.
  • Have a current DSM-5 diagnosis of Post-Traumatic Stress Disorder
  • Have a CAPS-5 total severity score of ≥35 at baseline
  • No antidepressant medications prior to enrollment
  • Be judged by study team clinicians to be at low risk for suicidality
  • Be medically stable
  • Have limited lifetime use of hallucinogens

General medical exclusion criteria:

  • Women who are pregnant
  • Cardiovascular conditions
  • Epilepsy with history of seizures
  • Insulin-dependent diabetes
  • Currently taking psychoactive prescription medication
  • Currently taking on a regular (e.g., daily) basis any medications having a primary centrally-acting serotonergic effect, including Monoamine oxidase inhibitors..

More than 25% outside the upper or lower range of ideal body weight

Psychiatric 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Psilocybin-assisted therapy
Participants will receive two doses of psilocybin, approximately 2 weeks apart, in conjunction with preparatory and post-psilocybin therapy sessions
Drug: Psilocybin
Participants will receive 15 mg of oral psilocybin in the first session and 25 mg in the second session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Type, severity, and frequency of Adverse Events (AEs) associated with psilocybin assisted therapy
Time Frame: 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
Baseline to Primary Endpoint (1 month post psilocybin session 2)
Columbia Suicide Severity Rating Scale (C-SSRS)
Time Frame: 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.
Baseline to Primary Endpoint (1 month post psilocybin session 2)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PTSD Symptom Severity as measured by the Clinician Administered PTSD Scale-5 (CAPS-5)
Time Frame: 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.
Baseline to Primary Endpoint (1 month post psilocybin session 2)
PTSD Checklist for Diagnostic and Statistical Manual Diploma in Social Medicine-5 (PCL-5)
Time Frame: 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.
Baseline to Primary Endpoint (1 month post psilocybin session 2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University

Investigators

  • Principal Investigator: Alan K Davis, PhD, Ohio State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Estimated)

January 31, 2025

Study Completion (Estimated)

July 31, 2025

Study Registration Dates

First Submitted

September 21, 2022

First Submitted That Met QC Criteria

September 21, 2022

First Posted (Actual)

September 26, 2022

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 13, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022H0280

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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