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PTSDPhase 2NCT05554094

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

A Phase 2 study testing Psilocybin in people with PTSD and Stress Disorders, Traumatic, run by Ohio State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 21 to 64 years
What is being tested?
Psilocybin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited States
Study dates
1 Jan 2023to 31 Jul 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site

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

    Columbus, Ohio, 43210

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Psilocybin
Keywords
psilocybin, psilocybin-assisted therapy, psychedelics, veterans
Medical subject headings
Stress Disorders, Post-Traumatic, Stress Disorders, Traumatic, Trauma and Stressor Related Disorders, Mental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PsilocybinDrug

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

Study groups in NCT05554094
Study groupRoleWhat they receive
Psilocybin-assisted therapyExperimentalParticipants will receive two doses of psilocybin, approximately 2 weeks apart, in conjunction with preparatory and post-psilocybin therapy sessions
Receives: Drug: Psilocybin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

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

  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.

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

Secondary outcomes (2)

  1. 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.

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

  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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2022
  2. Study start1 Jan 2023
  3. Primary completion31 Dec 2025
  4. Study completion31 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05554094
Sponsor's protocol ID
2022H0280
Status last verified
Oct 2026
First submitted
21 Sep 2022
Last updated
16 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33150319

  • 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.

    PubMed 34121583

  • 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.

    PubMed 32704581

  • 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.

    PubMed 33146667

  • 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.

    PubMed 28454621

  • 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.

    PubMed 31443821

  • Armstrong SB, Levin AW, Sepeda ND, Shaub H, Hunter T, Douglas A, Lancelotta R, Davis AK. Safety, feasibility, and preliminary clinical outcomes of psilocybin-assisted therapy for veterans with severe, treatment-resistant PTSD: an open-label pilot clinical trial. Commun Med (Lond). 2026 Jul 30;6(1):411. doi: 10.1038/s43856-026-01767-4.

    PubMed 42533157

  • 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.

    PubMed 37142308

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Psilocybin in people with PTSD and Stress Disorders, Traumatic, run by Ohio State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Type, severity, and frequency of Adverse Events (AEs) associated with psilocybin assisted therapy (time frame: Baseline to Primary Endpoint (1 month post psilocybin session 2)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05554094, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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