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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of psilocybin, a compound in certain mushrooms, combined with therapy to treat chronic PTSD, a mental health condition triggered by traumatic events. Researchers aim to determine if this combination is safe and effective for individuals who have had PTSD for at least six months and experience moderate to severe symptoms. The trial suits those who can pause psychiatric medications during the study and have not experienced issues like heart disease or certain mental health conditions. Participants will receive a single dose of psilocybin along with therapy sessions. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in PTSD treatment.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any psychiatric medications during the study period.

Is there any evidence suggesting that psilocybin is likely to be safe for humans?

Research shows that a single 25 mg dose of psilocybin is usually safe for people. Earlier studies found no serious side effects, and participants did not experience major problems after taking it. This suggests that psilocybin appears safe based on current information. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for PTSD, which often involve medications like SSRIs and therapy over extended periods, psilocybin offers a novel approach by potentially delivering significant results with a single dose. Psilocybin is a psychedelic compound that works by affecting serotonin receptors in the brain, which may help patients process traumatic memories and emotions differently. Researchers are excited about this treatment because it could lead to faster and possibly more enduring relief from PTSD symptoms compared to traditional methods.

What evidence suggests that psilocybin might be an effective treatment for PTSD?

This trial will investigate the effects of a single 25 mg dose of psilocybin on PTSD symptoms. Studies have shown that psilocybin can significantly improve these symptoms. Specifically, research indicates that a single 25 mg dose was well tolerated by patients, with no serious side effects. Patients experienced lasting reductions in PTSD symptoms and an improved quality of life after treatment. Psilocybin appears to aid by enhancing emotional processing, which is crucial for managing trauma. While this treatment looks promising, further research is needed to confirm these findings. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

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

Have hypertension using the standard criteria of the American Heart Association (values of 140/90 or higher assessed on three separate occasions)

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1.

ir.compasspathways.com

ir.compasspathways.com/News--Events-/news/news-details/2025/Compass-Pathways-Announces-Publication-of-Results-from-Phase-2-Study-of-COMP360-Psilocybin-for-Post-Traumatic-Stress-Disorder/default.aspx

News Details

Open-label Phase 2 study shows a single 25 mg COMP360 psilocybin dose was well tolerated, with no serious adverse events observed, ...

2.

journals.sagepub.com

journals.sagepub.com/doi/10.1177/02698811251362390

Investigating the safety and tolerability of single-dose ...

Secondary outcomes (PTSD symptom severity, functional impairment and quality of life) revealed consistent and durable pre-post treatment ...

3.

finance.yahoo.com

finance.yahoo.com/news/compass-pathways-announces-publication-results-103000296.html

Compass Pathways Announces Publication of Results from ...

Open-label Phase 2 study shows a single 25 mg COMP360 psilocybin dose was well tolerated, with no serious adverse events observed, ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12146596/

Clinical conceptualisation of PTSD in psilocybin treatment

Studies have shown that psilocybin can facilitate profound psychological experiences characterised by heightened emotional processing and ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05312151

NCT05312151 | The Safety and Tolerability of COMP360 in ...

Results Posted Record History. Study Overview. Brief Summary. The Safety and Tolerability of COMP360 in Participants with Post-traumatic Stress Disorder.

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40883964/

A nonrandomized open-label clinical trial

Aims: The trial's primary outcome was to investigate the safety and tolerability of single-dose psilocybin in participants with PTSD. Methods: ...