Psilocybin-Assisted Cognitive Processing Therapy for Chronic PTSD

ConditionsPost Traumatic Stress Disorder PTSD 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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

Psilocybin
Drug
Participants will receive a single dose of psilocybin 25mg combined with 12 sessions of massed CPT, and 2 psychotherapy sessions related to psilocybin over 7 days.

Treatment groups

15 Participants

are divided into 1 treatment group

Group A: ExperimentalExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Feasibility and tolerability

Recruitment rate, withdrawal rate, adherence rate, data completion rate, percentage of participants with severe adverse events.

Time frame

Up to 16 weeks

Secondary outcomes

Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total score

The CAPS-5 is a semi-structured clinical interview used to assess index history of DSM-5-defined traumatic event exposure, including the most distressing event, time since exposure, and total number of exposures, as well as frequency and severity of posttraumatic stress symptoms.

Time frame

Up to 16 weeks

Posttraumatic stress disorder Checklist-5 (PCL-5)

The PCL-5 is self-report questionnaire in which respondents indicate the presence and severity of PTSD symptoms, derived from the DSM-5 symptoms of PTSD.

Time frame

Up to 16 weeks

Patient Health Questionnaire-9 (PHQ-9)

The PHQ-9 is a self-rated measure of depressive symptom severity in the past two weeks. Each of the nine items is rated on a Likert scale, ranging from 0 (not at all) to 3 (nearly every day), and summed for a total score between 0 (no symptoms) to 27 (most severe).

Time frame

Up to 16 weeks

Generalized Anxiety Disorder Scale, 7-item (GAD-7)

Total score ranges from 0 to 21; a higher score denotes greater symptom severity.

Time frame

Up to 16 weeks

Other outcomes

Effect on digital physiological passive data collected through the use of a wearable device

Example: sleep, activity

Time frame

Up to 16 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Unity Health Toronto

Lead sponsor

Toronto Metropolitan University

Collaborator

University of Ottawa

Collaborator

Source ClinicalTrials.gov

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