Clinical TrialPTSDPsilocybinNot yet recruiting

Psilocybin-Assisted Cognitive Processing Therapy for Chronic PTSD

This open-label trial (n=15) will evaluate the feasibility, tolerability, safety, and efficacy of psilocybin-assisted (25mg) cognitive processing therapy for chronic Posttraumatic Stress Disorder (PTSD).

Target Enrollment
15 participants
Study Type
Phase II interventional
Design
Non-randomized

Detailed Description

Open-label, single-group Phase II study (n=15) evaluating a single 25 mg oral dose of psilocybin combined with 12 sessions of massed cognitive processing therapy (CPT) and two psilocybin-related psychotherapy sessions delivered over 7 days, with a 12-week follow-up.

Outcomes include feasibility, tolerability, safety, clinician-administered and self-report measures (e.g., CAPS-5), and continuous monitoring using a wearable device.

Study Protocol

Preparation

2 sessions

Dosing

1 sessions

Integration

sessions

Therapeutic Protocol

cbt

Study Arms & Interventions

Psilocybin + CPT

experimental

Single-group massed CPT with a single 25 mg psilocybin dosing session.

Interventions

  • Psilocybin25 mg
    via Oral• single dose• 1 doses total

    Single oral psilocybin 25 mg; combined with 12 sessions of massed CPT and 2 psilocybin-related psychotherapy sessions over 7 days.

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion 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

  • 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), recent myocardial infarction (< 1 year), clinically significant arrhythmia (< 1 year);
  • 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.

Study Details

  • Status
    Not yet recruiting
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment15 participants
  • Timeline
    Start: 2024-08-01
    End: 2025-05-31
  • Compound
    Psilocybin
  • Topic
    PTSD

Locations

St. Michael's Hospital, Unity Health Toronto — Toronto, Ontario, Canada

Your Library