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Active, not recruitingPhase 2

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

NCT05554094 · Ohio State University

Closed to entry
Status
Not accepting participants
Phase 2
Phase
15
Target enrolment
1
Study sites
1 US states

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Type, severity, and frequency of Adverse Events (AEs) associated with psilocybin assisted therapy

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

  • Columbia Suicide Severity Rating Scale (C-SSRS)

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

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

21 Years to 64 Years
Ages
All
Sex
Not accepted
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.. 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

Where

1 study site

FacilityCityRegionCountry
Ohio State University Department of Psychiatry and Behavioral Health at the Davis Medical Research CenterColumbusOhioUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT05554094 on ClinicalTrials.gov →

Last updated in the registry 2026-03-04. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits