NCT05554094

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_2

Timeline
3mo left

Started Jan 2023

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Jan 2023Jul 2026

First Submitted

Initial submission to the registry

September 21, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 26, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Expected
Last Updated

March 4, 2026

Status Verified

October 1, 2025

Enrollment Period

3 years

First QC Date

September 21, 2022

Last Update Submit

March 2, 2026

Conditions

Mental DisorderPTSDStress Disorders, TraumaticStress Disorders, Post-TraumaticTrauma and Stressor Related Disorders

Keywords

psilocybinpsilocybin-assisted therapypsychedelicsveterans

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • PTSD Symptom Severity as measured by the Clinician Administered PTSD Scale-5 (CAPS-5)

    Baseline to Primary Endpoint (1 month post psilocybin session 2)

  • PTSD Checklist for Diagnostic and Statistical Manual Diploma in Social Medicine-5 (PCL-5)

    Baseline to Primary Endpoint (1 month post psilocybin session 2)

Study Arms (1)

Psilocybin-assisted therapy

EXPERIMENTAL

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

Drug: Psilocybin

Interventions

PsilocybinDRUG

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

Psilocybin-assisted therapy

Eligibility Criteria

Age21 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may not qualify if:

  • 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..
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Columbus, Ohio, 43210, United States

Location

Related Publications (7)

  • 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.

    PMID: 33150319BACKGROUND

  • 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.

    PMID: 34121583BACKGROUND

  • 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.

    PMID: 32704581BACKGROUND

  • 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.

    PMID: 33146667BACKGROUND

  • 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.

    PMID: 28454621BACKGROUND

  • 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.

    PMID: 31443821BACKGROUND

  • Davis AK, Levin AW, Nagib PB, Armstrong SB, Lancelotta RL. Study protocol of an open-label proof-of-concept trial examining the safety and clinical efficacy of psilocybin-assisted therapy for veterans with PTSD. BMJ Open. 2023 May 4;13(5):e068884. doi: 10.1136/bmjopen-2022-068884.

    PMID: 37142308DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticStress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Interventions

Psilocybin

Intervention Hierarchy (Ancestors)

Indole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingTryptaminesIndolizidinesIndolizines

Study Officials

  • Alan K Davis, PhD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 21, 2022

First Posted

September 26, 2022

Study Start

January 1, 2023

Primary Completion

December 31, 2025

Study Completion (Estimated)

July 31, 2026

Last Updated

March 4, 2026

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)