Safety and Preliminary Efficacy of Organic Whole Psilocybin-Containing Mushrooms to Treat Patient… (NCT07275970) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Safety and Preliminary Efficacy of Organic Whole Psilocybin-Containing Mushrooms to Treat Patients Suffering From PTSD
United States24 participantsStarted 2026-03-20
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Individuals ≥ 18 years of age
. Have a diagnosis of Post-Traumatic Stress Disorder (PTSD) as defined:
. Willing and able to provide signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
. Be willing to commit to self-administering the study drug, to completing the QoL and PRO instruments, and attending all study visits.
. Participants must be able to evaluate their average pain on the BPI (Brief Pain Inventory) over the past week.
. Acceptable renal functioning as determined by no significant prior medical history and results of clinical laboratory evaluations done at Screening and on Day 1 (e.g., eGFR \>45 (mL/min/1.73 m2))
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number/Incidence of adverse events (AEs), and serious adverse events (SAEs) graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
. Acceptable hepatic functioning as determined by no significant prior medical history and results of clinical laboratory evaluations done at Screening and on Day 1 (e.g., liver enzymes ≤1.5x the upper limit of normal, 'ULN')
. Agree to only use the psilocybin mushroom provided by site staff and not use any other psilocybin (or similar drug) in any form for at least 30 days prior to Study Day 1 and for 30 days following the single-dose study drug treatment.
Exclusion criteria
. Currently uncontrolled hypertension. (\>140/90 at Screening and \>145/95 on Study Day 1).
. History of recent seizure (within 3 months of Study Day 1).
. History of stroke or transient ischemic attacks.
. Preexisting history of valvulopathy or pulmonary hypertension.
. A marked prolongation of QT interval (i.e., QT ≥450 msec) over a series of 3 ECGs performed within 5-6 minutes.