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Psychedelic Therapy

Psilocybin for PTSD

Phase 2
Waitlist Available
Research Sponsored by Unity Health Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Are willing to refrain from taking any psychiatric medications during the study period
Be older than 18 years old
Must not have
History of seizure disorder
Uncontrolled insulin-dependent diabetes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 16 weeks
Awards & highlights
No Placebo-Only Group

Summary

"This trial is looking at whether using psilocybin alongside therapy can help people with chronic PTSD by improving their ability to process and cope with their traumatic experiences."

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects are not listed, psilocybin can cause changes in perception, mood swings, nausea, and increased heart rate. Psychological support is usually offered during treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am willing to stop taking psychiatric medications for the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of seizures.
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I have diabetes that is not well-controlled with insulin.
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I am not pregnant, nursing, or if capable of becoming pregnant, I am using effective birth control.
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I haven't had a stroke, severe bleeding in the brain, heart attack, or serious heart rhythm problems in the last year.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 16 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Feasibility and tolerability
Secondary study objectives
24-items Multidimensional Psychological Flexibility Inventory (MPFI-24)
Acceptance/Avoidance-Promoting Experiences Questionnaire (APEQ)
Altered States of Consciousness Rating Scale (ASC)
+16 more
Other study objectives
Effect on digital physiological passive data collected through the use of a wearable device

Side effects data

From 2021 Phase 2 trial • 95 Patients • NCT02061293
9%
Nausea
7%
Pain
7%
Viral upper resp. tract infection
7%
Back pain
7%
Bronchitis
4%
Diarrhea
4%
Influenza
4%
Headache
4%
Sinus headache
4%
Depressed mood
4%
Depression
4%
Insomnia
4%
Suicidal Ideation
4%
Lower resp. tract congestion
4%
Oropharyngeal pain
4%
Alcohol withdrawal syndrome
2%
Migraine
2%
Thrombocytosis
2%
Constipation
2%
Vomiting
2%
Oedema
2%
Peripheral swelling
2%
Pyrexia
2%
Dermatitis contact
2%
Bronchitis bacterial
2%
Eye infection
2%
Fungal infection
2%
Traumatic lung injury
2%
Hyponatremia
2%
Arthralgia
2%
Musculoskeletal pain
2%
Pain in extremity
2%
Malignant melanoma
2%
Dizziness
2%
Hypoesthesia
2%
Sedation
2%
Anger
2%
Anxiety
2%
Restlessness
2%
Cough
2%
Rhinorrhea
2%
Sinus congestion
2%
Sexual abuse
2%
Endodontic procedure
2%
Mallory-Weiss Syndrom
2%
Anemia
2%
Influenza like Illness
2%
Gingivitis
2%
Arthoscopic surgery
100%
80%
60%
40%
20%
0%
Study treatment Arm
Diphenhydramine
Psilocybin

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: ExperimentalExperimental Treatment1 Intervention
Single dose of psilocybin 25mg Massed cognitive processing therapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
2021
Completed Phase 2
~530

Find a Location

Who is running the clinical trial?

Unity Health TorontoLead Sponsor
561 Previous Clinical Trials
455,661 Total Patients Enrolled
Toronto Metropolitan UniversityOTHER
92 Previous Clinical Trials
19,191 Total Patients Enrolled
University of OttawaOTHER
221 Previous Clinical Trials
269,634 Total Patients Enrolled
~4 spots leftby Mar 2025
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