NCT06386003 Psilocybin-Assisted Cognitive Processing Therapy for Chronic PTSD
| NCT ID | NCT06386003 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Unity Health Toronto |
| Condition | Post Traumatic Stress Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2026-06 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 15 participants in total. It began in 2026-06 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06386003 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Post Traumatic Stress Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06386003 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06386003 currently recruiting?
Yes, NCT06386003 is actively recruiting participants. Contact the research team at Venkat.Bhat@unityhealth.to for enrollment information.
Where is the NCT06386003 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT06386003 clinical trial?
NCT06386003 is sponsored by Unity Health Toronto. The trial plans to enroll 15 participants.