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Post Traumatic Stress DisorderPhase 2NCT06386003

Psilocybin-Assisted Cognitive Processing Therapy for Chronic PTSD

A Phase 2 study testing Psilocybin in people with Post Traumatic Stress Disorder and PTSD, run by Unity Health Toronto at 1 site in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Post Traumatic Stress Disorder, PTSD, Chronic PTSD
What is being tested?
Psilocybin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteCanada
Study dates
1 Jun 2026to Jun 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • St. Michael's Hospital, Unity Health Toronto

    Toronto, Ontario, M5S 1A1

Other trials in Canada

About this study

Official title: Psilocybin-Assisted Massed Cognitive Processing Therapy for Chronic Posttraumatic Stress Disorder: An Open-label 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).

Read the detailed description

Current front-line treatments for Posttraumatic stress disorder (PTSD) are ineffective for up to half of patients, with serious medical and societal consequences. It is imperative to improve the efficacy of front-line treatment options, such as cognitive processing therapy (CPT). CPT is an effective treatment for PTSD, including when delivered intensively (i.e., multiple sessions over 7 days). However, a substantial proportion of patients continue to meet criteria for PTSD or have residual PTSD symptoms post-treatment. Psilocybin-assisted CPT may be a potential solution, as preliminary evidence supports the potential of psilocybin to alleviate symptoms of PTSD.

Fifteen 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. Participants will complete clinician-administered scales, self-reported mental health questionnaires, and use a wearable device. After the 1-week interventional period, participants will enter a 12-weeks follow-up period.

Being tested
Psilocybin
Keywords
Post Traumatic Stress Disorder, Psilocybin, Cognitive Processing Therapy
Medical subject headings
Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PsilocybinDrug

    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.

Study groups in NCT06386003
Study groupRoleWhat they receive
ExperimentalExperimentalSingle dose of psilocybin 25mg + Massed cognitive processing therapy
Receives: Drug: Psilocybin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility and tolerability

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

    Measured: Up to 16 weeks

Secondary outcomes (20)

  1. 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.

    Measured: Up to 16 weeks

  2. 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.

    Measured: Up to 16 weeks

  3. 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).

    Measured: Up to 16 weeks

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

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

    Measured: Up to 16 weeks

  5. Dissociative Experiences Scale II (DES-II)

    The Dissociative Experiences Scale II is a 28-item, self-report measure of dissociative experiences.

    Measured: Up to 13 weeks

  6. Pittsburgh Sleep Quality Index (PSQI)

    The PSQI is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval.

    Measured: Up to 13 weeks

  7. World Health Organization Well-Being Index, 5-item (WHO-5)

    The WHO-5 is a measure of overall well-being, rated on a scale of 0 to 25, with higher scores denoting higher quality of life.

    Measured: Up to 16 weeks

  8. Quality of relationships inventory (QRI)

    The QRI is a self-report questionnaire used to determine the quality relationships consisting of 25 items that are evaluated on a 4-point Likert scale ranging from 1 = not true to 4 = almost always true.

    Measured: Up to 13 weeks

  9. Inventory of psychosocial functioning (IPF)

    The IPF is an 80-item self-report instrument measuring PTSD-related functional impairment in the past 30 days.

    Measured: Up to 13 weeks

  10. Posttraumatic Maladaptive Beliefs Scale (PMBS)

    The PMBS is a 15-item scale that was developed to measure maladaptive beliefs about life circumstances that may occur following trauma exposure.

    Measured: Up to 13 weeks

  11. Brief Experiential Avoidance Questionnaire (BEAQ)

    The BEAQ is a 15-item self-report measure of experiential avoidance.

    Measured: Up to 13 weeks

  12. 24-items Multidimensional Psychological Flexibility Inventory (MPFI-24)

    The MPFI-24 is a 24-item self-report scale developed to assess the specific components of psychological flexibility and inflexibility.

    Measured: Up to 13 weeks

  13. Working Alliance Inventory- Short Form (WAI-SF)

    The WAI-SF is a patient-rated measure of the alliance between a therapist and client.

    Measured: Up to Day 7

  14. Difficulties in Emotion Regulation Scale-Short Form (DERS-SF)

    The DERS-SF is an 18-item measure used to identify emotional regulation issues in adults.

    Measured: Up to 13 weeks

  15. Self-Compassion Scale-Short Form (SCS-SF)

    The SCS-SF is a 12-item self-report measure of self-compassion.

    Measured: Up to 13 weeks

  16. Psychological Insight Questionnaire (PIQ)

    The PIQ is a 23-item self-report measure of acute experiences of insight (e.g. awareness into emotions, behaviors, beliefs, memories, or relationships) after taking a psychedelic.

    Measured: Up to Day 3

  17. Emotional Breakthrough Inventory (EBI)

    The EBI is a measure of emotional release/breakthrough experienced during the acute psychedelic state.

    Measured: Up to Day 3

  18. Altered States of Consciousness Rating Scale (ASC)

    The ASC measures altered states of consciousness.

    Measured: Up to Day 3

  19. Acceptance/Avoidance-Promoting Experiences Questionnaire (APEQ)

    The APEQ is a psychometric self-report tool for measuring aspects of the acute psychedelic experience that are associated with longer-term changes in psychological flexibility.

    Measured: Up to Day 3

  20. Childhood Trauma Questionnaire-short form (CTQ-SF)

    Measured: Screening

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Apr 2024
  2. Study start1 Jun 2026
  3. Primary completionJan 2028 (estimated)
  4. Study completionJun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06386003
Sponsor's protocol ID
23-230
Status last verified
Dec 2025
First submitted
18 Apr 2024
Last updated
6 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Meshkat S, J Zeifman R, Stewart K, Janssen-Aguilar R, Lou W, Jetly R, Monson CM, Bhat V. Psilocybin-assisted massed cognitive processing therapy for chronic posttraumatic stress disorder: Protocol for an open-label pilot feasibility trial. PLoS One. 2025 Jan 17;20(1):e0313741. doi: 10.1371/journal.pone.0313741. eCollection 2025.

    PubMed 39823496

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Psilocybin in people with Post Traumatic Stress Disorder and PTSD, run by Unity Health Toronto at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility and tolerability (time frame: Up to 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06386003, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.

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