RecruitingPhase 1NCT07275970

Safety and Preliminary Efficacy of Organic Whole Psilocybin-Containing Mushrooms to Treat Patients Suffering From PTSD

An Open-Label, Phase 1 Study of the Safety Pharmacokinetic Profile, and Preliminary Efficacy, of Organic Whole Psilocybin-Containing Mushrooms in Patients Suffering From PTSD


Sponsor

Suzanne "Sue" Sisley MD

Enrollment

24 participants

Start Date

Feb 9, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether a single dose of whole psilocybin-containing mushrooms (the natural form of psilocybin) can safely and effectively reduce symptoms of PTSD (post-traumatic stress disorder) in adults who have experienced trauma. **You may be eligible if...** - You are 18 or older - You have a formal PTSD diagnosis (meeting DSM-5 criteria) lasting at least 6 months - Your PTSD symptoms are at a moderate-to-severe level - You are able to attend in-person study visits - You are proficient in reading and writing English - You have adequate kidney and liver function - You are willing to stop using psilocybin or similar substances for 30 days before and after the study drug **You may NOT be eligible if...** - You have uncontrolled high blood pressure - You have had a stroke, seizure (within 3 months), or serious heart condition - You have severe anxiety or severe depression (scores above specific thresholds) - You have recent suicidal thoughts or behavior - You are currently taking SSRIs, SNRIs, MAOIs, or other serotonin-affecting medications - You have uncontrolled diabetes - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGPsychedelic

Organic Whole Psilocybin-Containing Mushrooms


Locations(1)

Scottsdale Research Institute

Scottsdale, Arizona, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07275970


Related Trials