Your session is about to expire
← Back to Search
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
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 belowSelect...
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:Select...
I have a history of seizures.
Select...
I have diabetes that is not well-controlled with insulin.
Select...
I am not pregnant, nursing, or if capable of becoming pregnant, I am using effective birth control.
Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 16 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 16 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility and tolerability
Secondary outcome measures
24-items Multidimensional Psychological Flexibility Inventory (MPFI-24)
Acceptance/Avoidance-Promoting Experiences Questionnaire (APEQ)
Altered States of Consciousness Rating Scale (ASC)
+16 moreOther outcome measures
Effect on digital physiological passive data collected through the use of a wearable device
Side effects data
From 2021 Phase 2 trial • 95 Patients • NCT020612939%
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
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
~750
Find a Location
Who is running the clinical trial?
Unity Health TorontoLead Sponsor
549 Previous Clinical Trials
451,059 Total Patients Enrolled
Toronto Metropolitan UniversityOTHER
88 Previous Clinical Trials
16,296 Total Patients Enrolled
University of OttawaOTHER
210 Previous Clinical Trials
268,174 Total Patients Enrolled
Share this study with friends
Copy Link
Messenger