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

Primary Purpose

PTSD, Stress Disorders, Traumatic, Stress Disorders, Post-Traumatic

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Psilocybin
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PTSD focused on measuring psilocybin, psilocybin-assisted therapy, psychedelics, veterans

Eligibility Criteria

21 Years - 64 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Ohio State University Department of Psychiatry and Behavioral Health at the Davis Medical Research CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Psilocybin-assisted therapy

Arm Description

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

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
September 21, 2022
Last Updated
March 28, 2023
Sponsor
Ohio State University
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1. Study Identification

Unique Protocol Identification Number
NCT05554094
Brief Title
Psilocybin for the Treatment of Veterans With Post-Traumatic Stress Disorder
Official Title
Examining the Safety and Clinical Efficacy of Psilocybin Therapy for Veterans With PTSD: An Open-Label Proof-of-Concept Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
January 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PTSD, Stress Disorders, Traumatic, Stress Disorders, Post-Traumatic, Trauma and Stressor Related Disorders, Mental Disorder
Keywords
psilocybin, psilocybin-assisted therapy, psychedelics, veterans

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Psilocybin-assisted therapy
Arm Type
Experimental
Arm Description
Participants will receive two doses of psilocybin, approximately 2 weeks apart, in conjunction with preparatory and post-psilocybin therapy sessions
Intervention Type
Drug
Intervention Name(s)
Psilocybin
Intervention Description
Participants will receive 15 mg of oral psilocybin in the first session and 25 mg in the second session.
Primary Outcome Measure Information:
Title
Type, severity, and frequency of Adverse Events (AEs) associated with psilocybin assisted therapy
Description
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
Time Frame
Baseline to Primary Endpoint (1 month post psilocybin session 2)
Title
Columbia Suicide Severity Rating Scale (C-SSRS)
Description
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.
Time Frame
Baseline to Primary Endpoint (1 month post psilocybin session 2)
Secondary Outcome Measure Information:
Title
PTSD Symptom Severity as measured by the Clinician Administered PTSD Scale-5 (CAPS-5)
Description
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.
Time Frame
Baseline to Primary Endpoint (1 month post psilocybin session 2)
Title
PTSD Checklist for Diagnostic and Statistical Manual Diploma in Social Medicine-5 (PCL-5)
Description
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.
Time Frame
Baseline to Primary Endpoint (1 month post psilocybin session 2)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adam Levin, MD
Phone
6143665495
Email
Adam.levin@osumc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Stacey Armstrong, PhD
Phone
6142926940
Email
armstrong.1014@osu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan K Davis, PhD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio State University Department of Psychiatry and Behavioral Health at the Davis Medical Research Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam Levin, MD
Phone
614-366-5495
Email
adam.levin@osumc.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33150319
Citation
Anderson BT, Danforth A, Daroff PR, Stauffer C, Ekman E, Agin-Liebes G, Trope A, Boden MT, Dilley PJ, Mitchell J, Woolley J. Psilocybin-assisted group therapy for demoralized older long-term AIDS survivor men: An open-label safety and feasibility pilot study. EClinicalMedicine. 2020 Sep 24;27:100538. doi: 10.1016/j.eclinm.2020.100538. eCollection 2020 Oct.
Results Reference
background
PubMed Identifier
34121583
Citation
Bird CIV, Modlin NL, Rucker JJH. Psilocybin and MDMA for the treatment of trauma-related psychopathology. Int Rev Psychiatry. 2021 May;33(3):229-249. doi: 10.1080/09540261.2021.1919062. Epub 2021 Jun 14.
Results Reference
background
PubMed Identifier
32704581
Citation
Davis AK, Averill LA, Sepeda ND, Barsuglia JP, Amoroso T. Psychedelic Treatment for Trauma-Related Psychological and Cognitive Impairment Among US Special Operations Forces Veterans. Chronic Stress (Thousand Oaks). 2020 Jul 8;4:2470547020939564. doi: 10.1177/2470547020939564. eCollection 2020 Jan-Dec.
Results Reference
background
PubMed Identifier
33146667
Citation
Davis AK, Barrett FS, May DG, Cosimano MP, Sepeda ND, Johnson MW, Finan PH, Griffiths RR. Effects of Psilocybin-Assisted Therapy on Major Depressive Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2021 May 1;78(5):481-489. doi: 10.1001/jamapsychiatry.2020.3285. Erratum In: JAMA Psychiatry. 2021 Feb 10;:
Results Reference
background
PubMed Identifier
28454621
Citation
Krystal JH, Davis LL, Neylan TC, A Raskind M, Schnurr PP, Stein MB, Vessicchio J, Shiner B, Gleason TC, Huang GD. It Is Time to Address the Crisis in the Pharmacotherapy of Posttraumatic Stress Disorder: A Consensus Statement of the PTSD Psychopharmacology Working Group. Biol Psychiatry. 2017 Oct 1;82(7):e51-e59. doi: 10.1016/j.biopsych.2017.03.007. Epub 2017 Mar 14. No abstract available. Erratum In: Biol Psychiatry. 2018 Feb 1;83(3):296.
Results Reference
background
PubMed Identifier
31443821
Citation
Nichter B, Norman S, Haller M, Pietrzak RH. Physical health burden of PTSD, depression, and their comorbidity in the U.S. veteran population: Morbidity, functioning, and disability. J Psychosom Res. 2019 Sep;124:109744. doi: 10.1016/j.jpsychores.2019.109744. Epub 2019 Jun 17.
Results Reference
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Psilocybin for the Treatment of Veterans With Post-Traumatic Stress Disorder

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