Actively Recruiting
Safety and Preliminary Efficacy of Organic Whole Psilocybin-Containing Mushrooms to Treat Patients Suffering From PTSD
Led by Suzanne "Sue" Sisley MD · Updated on 2026-03-09
24
Participants Needed
1
Research Sites
2 weeks
Total Duration
On this page
Sponsors
S
Suzanne "Sue" Sisley MD
Lead Sponsor
S
Scottsdale Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study will examine the safety and preliminary efficacy of psilocybin mushrooms to treat adults with PTSD. Up to 24 participants will take part in this study. Each participant will ingest psilocybin from dried mushrooms in a chocolate formulation.
CONDITIONS
Official Title
Safety and Preliminary Efficacy of Organic Whole Psilocybin-Containing Mushrooms to Treat Patients Suffering From PTSD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with PTSD lasting 6 months or longer, meeting DSM-5 criteria
- Experienced at least one traumatic event as determined by LEC-5
- Scored at least 33 on the PCL-5
- Able and willing to provide signed informed consent
- Willing to self-administer the study drug and complete quality of life and patient-reported outcome instruments
- Able to evaluate average pain using the Brief Pain Inventory
- Acceptable kidney function (eGFR >45 mL/min/1.73 m2) and liver function (liver enzymes ≤1.5x upper limit of normal)
- Agree to use only study-provided psilocybin mushrooms and avoid other similar substances 30 days before and after dosing
- Willing to wear and sync a health tracking wearable device daily during study
- Agree to avoid psychoactive drugs, alcohol, certain medications, cannabis, and non-routine drugs within 24 hours before dosing
- Stable on any pre-study medications or psychotherapy and report changes during study
- If female of childbearing potential, negative pregnancy test at screening and dosing, and willing to use effective birth control during 30-day post-treatment
- Proficient in English and able to communicate with study staff
- Agree not to participate in other interventional clinical trials during this study
You will not qualify if you...
- Uncontrolled hypertension (>140/90 at screening or >145/95 on dosing day)
- History of seizure within 3 months prior to dosing
- History of stroke or transient ischemic attacks
- Preexisting valvulopathy or pulmonary hypertension
- Marked QT interval prolongation (≥450 msec) on ECG
- Uncontrolled diabetes (HbA1c >8.0%)
- Use of centrally-acting serotonergic agents within 24 hours before and 72 hours after dosing
- Significant suicide risk or suicidal behaviors within specified timeframes
- Severe anxiety (GAD-7 score ≥15) or depression (PHQ-9 score ≥20)
- Pregnant, nursing, or women not using effective birth control
- Allergies or contraindications to psilocybin mushrooms
- Use of psilocybin, LSD, DMT, Ayahuasca, Peyote, mescaline, or ketamine within 30 days prior to dosing
- Unable to attend face-to-face visits or planning to move away before 3-month follow-up
- Any condition that might interfere with participation or safety as judged by investigator or medical monitor
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Scottsdale Research Institute
Scottsdale, Arizona, United States, 85022
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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