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RecruitingPhase 2

Psilocybin-Assisted Cognitive Processing Therapy for Chronic PTSD

NCT06386003 · Unity Health Toronto

Recruiting
Status
Accepting participants
Phase 2
Phase
15
Target enrolment
1
Study sites
Outside the US

What it is testing

Summary

This is an open-label trial evaluating feasibility, tolerability, safety and efficacy of psilocybin assisted cognitive processing therapy for chronic Posttraumatic Stress Disorder (PTSD).

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

  • Feasibility and tolerability

    Measured over Up to 16 weeks

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

18 Years to 65 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: 1. Meet Diagnostic and Statistical Manual-5th edition (DSM-5) criteria for current PTSD with a duration of 6 months or longer assessed by study psychiatrist; 2. Have a Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) score of 50 or higher, indicating moderate to severe PTSD symptoms; 3. Are willing to refrain from taking any psychiatric medications during the study period. Exclusion Criteria: 1. Are pregnant or nursing, or are women of child bearing potential who are not practicing an effective means of birth control; 2. Have a history of or a current primary diagnosis of psychotic disorder, schizophrenia, delusional disorder, borderline personality disorder, schizoaffective disorder, bipolar disorder or, dissociative identity disorder; 3. Have evidence or history of coronary artery disease or cerebral or peripheral vascular disease, hepatic disease with abnormal liver enzymes, or any other medical disorder judged by the investigator to significantly increase the risk of psilocybin administration; 4. Have hypertension using the standard criteria of the American Heart Association (values of 140/90 or higher assessed on three separate occasions; 5. History of seizure disorder; 6. Uncontrolled insulin-dependent diabetes; 7. Recent stroke, intracranial or subarachnoid hemorrhage (\< 1 year from signing of informed consent form \[ICF\]), recent myocardial infarction (\< 1 year from signing of ICF), clinically significant arrhythmia (\< 1 year from signing of ICF); 8. Have liver disease with the exception of asymptomatic subjects with Hepatitis C who have previously undergone evaluation and successful treatment; 9. Lifetime history of substance-induced psychosis; 10. Lifetime history of substance use disorder with a hallucinogen; 11. History of alcohol use disorder in the past 3 months.

Where

1 study site

FacilityCityRegionCountry
St. Michael's Hospital, Unity Health TorontoTorontoOntarioCanada

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.

NCT06386003 on ClinicalTrials.gov →

Last updated in the registry 2026-06-26. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits