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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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PTSD, Stress Disorders, Traumatic, Stress Disorders, Post-Traumatic, Trauma and Stressor Related Disorders, Mental Disorder

Intervention / Treatment
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* Drug: Psilocybin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type, severity, and frequency of Adverse Events (AEs) associated with psilocybin assisted therapy | 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) | 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) | 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) | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psilocybin, psilocybin-assisted therapy, psychedelics, veterans