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

PTSD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05554094
• Other study ID #: 2022H0280
• Status: Recruiting
• Phase: Phase 2
• Start date: January 1, 2023
• Est. completion date: July 31, 2025

Study information

• Verified date: May 2024
• Source: Ohio State University
• Contact: Adam Levin, MD
• Phone: 6143665495
• Email: Adam.levin[@]osumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: July 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 64 Years

Eligibility

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..

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Psilocybin
Participants will receive 15 mg of oral psilocybin in the first session and 25 mg in the second session.

Locations

Country	Name	City	State
United States	Ohio State University Department of Psychiatry and Behavioral Health at the Davis Medical Research Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View 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. — View 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. — View 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;: — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)