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

NCT07275970 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: SRI-HRTT21
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

PTSD

Keywords

ptsd; psilocybin; psychedelic; psilocin; post-traumatic stress disorder; mushrooms

Outcome Measures

Primary Outcomes (2)

• 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.

  From dosing to 3-month follow-up

• Number/Incidence of Mental and Psychotic AE's

  From dosing to 3-month follow-up

Secondary Outcomes (3)

• Maximum Plasma Concentration (Cmax) of Psilocin

  pre-dose to 8-hours post-dose

• Time to Maximum Plasma Concentration (Tmax) of Psilocin

  Pre-dose to 8 hours post-dose

• Area Under the Curve (AUC₀-₈) for Psilocin

  Pre-dose to 8 hours post-dose

Study Arms (1)

30mg of psilocybin administered orally in a single dosing session

EXPERIMENTAL

Drug: Psychedelic

Interventions

Psychedelic DRUG

Organic Whole Psilocybin-Containing Mushrooms

30mg of psilocybin administered orally in a single dosing session

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals ≥ 18 years of age
• Have a diagnosis of Post-Traumatic Stress Disorder (PTSD) as defined:
• Meet Diagnostic and Statistical Manual-5th edition (DSM-5) criteria for current PTSD with a duration of 6 months or longer as assessed by a study psychiatrist.
• Determination of at least one traumatic event as determined by the LEC-5
• A score of at least 33 on the PCL-5
• 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.
• Willingly agreed to provide verbal consent to provide needed pre-screening information, including medical history, concomitant medications, etc., prior to signing the ICF.
• 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))
• 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.
• Is willing to wear, sync daily, and charge twice weekly a provisioned health tracking wearable device every day during sleep and daily activity. If the participant already has the same, or compatible device, they can use their own.
• Agree to not use any psychoactive drugs, partake alcoholic beverages, self-administer ondansetron (or other selective serotonin reuptake inhibitors 'SSRIs', serotonin-norepinephrine reuptake inhibitors, 'SNRIs' and monoamine oxidase inhibits, 'MAOs'), cannabis, and/or any other non-routine PRN medications within 24 hours of Study Day 1. Exceptions include daily use of caffeine, nicotine, and opioid pain medication
• Be stable on any pre-study medications and/or psychotherapy regimen prior to study entry. Agree to inform physician(s)/clinician(s) providing current care about your participation in the study (or permit the research site study staff to do so). Agree to report any changes in medication or psychotherapy treatment regimen during the study, to study staff.

You may not qualify if:

• 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.
• Currently uncontrolled diabetes (HbA1c \> 8.0%). 7. Potential for adverse drug-drug interactions such as the use of centrally-acting serotonergic agents within 24 hours prior to and for 72 hours following study drug administration on Study Day 1.
• \. Significant suicide risk defined by (1) suicidal ideation as endorsed on items 4 or 5 on the Columbia Suicidal Severity Rating Scale (C-SSRS) within the last 6 months, at Screening, or at Baseline (Visit 1), or; (2) suicidal behaviors within the last 12 months as assessed by C-SSRS.
• \. Patients with severe anxiety and depression measured as following: Participants with scores of 15 \& above on Generalized Anxiety Disorder-7 (GAD-7) scale, and/or with scores of 20 \& above on Patient Health Questionnaire-9 (PHQ -9).
• \. Are pregnant or nursing or are women of childbearing potential who are not practicing a highly effective means of birth control.
• \. Have any allergies or contraindication to psilocybin mushrooms. 12. Current users of psilocybin, LSD, DMT, Ayahuasca, Peyote, mescaline, and ketamine over the past 30 days will not qualify for the study unless the use of these agents is stopped for 30 days prior to Study Day 1 and the participant agrees to not use these (or similar) agents for 30 days after Study Day 1.
• \. Are not able to attend face-to-face visits at the study site or plan to move out of the area prior to the 3-month LTFU visit.
• \. Have any current problem that, in the opinion of the Investigator or Medical Monitor, might interfere with an individual's participation in the study or confound the assessment of safety and/or efficacy of the study drug.

Sponsors & Collaborators

• Scottsdale Research Institute: collaborator
• Suzanne "Sue" Sisley MD: lead

Study Sites (1)

Scottsdale Research Institute

Scottsdale, Arizona, 85022, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Hallucinogens

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Psychotropic Drugs; Central Nervous System Agents; Therapeutic Uses

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 10, 2025
• Study Start: February 9, 2026
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-01

Locations

US (1)