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

Sponsor

Ohio State University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05554094

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
PTSD Stress Disorders, Traumatic Stress Disorders, Post-Traumatic Trauma and Stressor Related Disorders Mental Disorder	Drug: Psilocybin	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Jan 31, 2024

Anticipated Study Completion Date :

Jan 31, 2025

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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