Psilocybin-Assisted Cognitive Processing Therapy for Chronic PTSD

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUnity Health Toronto

About this trial

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

Qualifiers

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.

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Psilocybin

Treatment groups

15 Participants
are divided into 1 treatment group

Sponsors and collaborators

Unity Health Toronto

Lead sponsor

Toronto Metropolitan University

Collaborator

University of Ottawa

Collaborator