Psilocybin for PTSD

Overseen By Venkat Bhat

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Unity Health Toronto

Must not be taking: Psychiatric medications

Disqualifiers: Pregnancy, Psychotic disorders, Heart disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 14

Duration: 1 week

15 Participants Needed

Trial Summary

What is the purpose of 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 is for individuals with chronic PTSD. Specific eligibility details are not provided, but typically participants must meet diagnostic criteria for PTSD and be stable enough to undergo the treatment.

Inclusion Criteria

I am willing to stop taking psychiatric medications for the study.

Have a Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) score of 50 or higher, indicating moderate to severe PTSD symptoms

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

Exclusion Criteria

I have diabetes that is not well-controlled with insulin.

History of alcohol use disorder in the past 3 months

Lifetime history of substance-induced psychosis

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of psilocybin 25mg combined with 12 sessions of massed cognitive processing therapy and 2 psychotherapy sessions over 7 days

1 week

14 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Treatment Details

Interventions

• Psilocybin

Trial Overview The study is testing the use of psilocybin (a psychedelic compound) in combination with cognitive processing therapy to see if it's safe and effective for treating chronic PTSD.

Participant Groups

Group I: Experimental Experimental Treatment 1 Intervention

Single dose of psilocybin 25mg Massed cognitive processing therapy

Psilocybin is already approved in United States, European Union for the following indications:

Approved in United States as Psilocybin for:

• Treatment-resistant depression (TRD) under Breakthrough Therapy designation

Approved in European Union as Psilocybin for:

• Treatment-resistant depression (TRD) under PRIME designation

Who Is Running the Clinical Trial?

Unity Health Toronto

Lead Sponsor

Trials

572

Recruited

470,000+

Toronto Metropolitan University

Collaborator

Trials

95

Recruited

19,300+

University of Ottawa

Collaborator

Trials

231

Recruited

267,000+