Psilocybin-Assisted Cognitive Processing Therapy for Chronic PTSD

Recruiting now · Phase 2

Conditions studied: Post Traumatic Stress Disorder, PTSD, Chronic PTSD

In brief

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

Key facts

Study ID

NCT06386003

Run by

Unity Health Toronto

People needed

15

Starts

2026-06-01

Expected to finish

2027-01-01

Last updated by the study team

2026-06-26

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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;
• Have a Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) score of 50 or higher, indicating moderate to severe PTSD symptoms;
• Are willing to refrain from taking any psychiatric medications during the study period.

You may not qualify if…

• Are pregnant or nursing, or are women of child bearing potential who are not practicing an effective means of birth control;
• 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;
• 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;
• Have hypertension using the standard criteria of the American Heart Association (values of 140/90 or higher assessed on three separate occasions;
• History of seizure disorder;
• Uncontrolled insulin-dependent diabetes;
• 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);
• Have liver disease with the exception of asymptomatic subjects with Hepatitis C who have previously undergone evaluation and successful treatment;
• Lifetime history of substance-induced psychosis;
• Lifetime history of substance use disorder with a hallucinogen;
• History of alcohol use disorder in the past 3 months.

Where it is running

• St. Michael's Hospital, Unity Health Toronto — Toronto, Ontario, Canada (enrolling)

Full record on ClinicalTrials.gov

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