PTSDPhase 1PASSAGENCT07275970
Safety and Preliminary Efficacy of Organic Whole Psilocybin-Containing Mushrooms to Treat Patients Suffering From PTSD
A Phase 1 study testing Psychedelic in people with PTSD, run by Scottsdale Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PTSD
- What is being tested?
- Psychedelic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2026to 1 Oct 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 19Show fewer
- •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.
- If female and of childbearing potential, the participant is eligible for the trial only with a negative urine pregnancy test during Screening and on Study Day 1. [If a result is uncertain (e.g., potential false positive), a serum human chorionic gonadotropin (hHCG) test may be performed prior to the administration of the study drug.] Fertile females agree to use a highly effective form of birth control during the 30-day posttreatment period and must confirm that they have no intent to try to become pregnant or any need to breastfeed during this period.
- Adequate birth control methods include intrauterine device (IUD), injected or implanted hormonal methods, oral hormones plus a barrier contraception, or double barrier contraception. Two forms of contraception are required with any barrier method or oral hormones (i.e., condom and diaphragm, condom or diaphragm and spermicide, oral hormonal contraceptives and spermicide or condom). Not of childbearing potential is defined as permanent sterilization or postmenopausal females.
- Be proficient in reading and writing in English and able to effectively communicate with site staff.
- Agree not to participate in any other interventional clinical trials during the study.
Who cannot join
- 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.
Show all 12Show fewer
- 8. 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.
- 9. 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).
- 10. Are pregnant or nursing or are women of childbearing potential who are not practicing a highly effective means of birth control.
- 11. 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.
- 13. 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.
- 14. 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Scottsdale Research Institute
Scottsdale, Arizona, 85022
About this study
Official title: 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
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
- Being tested
- Psychedelic
- Keywords
- ptsd, psilocybin, psychedelic, psilocin, post-traumatic stress disorder, mushrooms
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychedelicDrug
Organic Whole Psilocybin-Containing Mushrooms
| Study group | Role | What they receive |
|---|---|---|
| 30mg of psilocybin administered orally in a single dosing session | Experimental | Not described Receives: Drug: Psychedelic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From dosing to 3-month follow-up
Number/Incidence of Mental and Psychotic AE's
Measured: From dosing to 3-month follow-up
Secondary outcomes (3)
Maximum Plasma Concentration (Cmax) of Psilocin
Cmax will be determined using non-compartmental analysis of plasma psilocin concentrations.
Measured: pre-dose to 8-hours post-dose
Time to Maximum Plasma Concentration (Tmax) of Psilocin
Tmax will be calculated as the time point at which the maximum psilocin concentration occurs.
Measured: Pre-dose to 8 hours post-dose
Area Under the Curve (AUC₀-₈) for Psilocin
AUC₀-₈ will be calculated using the linear trapezoidal method to assess total psilocin exposure.
Measured: Pre-dose to 8 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start20 Mar 2026
- Primary completion30 Jul 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scottsdale Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07275970
- Sponsor's protocol ID
- SRI-HRTT21
- Acronym
- PASSAGE
- Status last verified
- Jul 2026
- First submitted
- 26 Nov 2025
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07275970
- Acronym / sponsor ID
- PASSAGE / SRI-HRTT21
- Conditions
- PTSD
- Keywords
- ptsd, psilocybin, psychedelic, psilocin, post-traumatic stress disorder, mushrooms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Scottsdale Research InstituteUniversity, hospital or other
- Study start
- 20 Mar 2026 (actual)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 10 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 30mg of psilocybin administered orally in a single dosing session | Experimental | Drug: Psychedelic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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.
- •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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PsychedelicOrganic Whole Psilocybin-Containing Mushrooms | Drug | 30mg of psilocybin administered orally in a single dosing session |
Primary outcome
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.
Time frame: From dosing to 3-month follow-up
Number/Incidence of Mental and Psychotic AE's
Time frame: From dosing to 3-month follow-up
3 secondary outcomes
Maximum Plasma Concentration (Cmax) of Psilocin
Time frame: pre-dose to 8-hours post-dose
Time to Maximum Plasma Concentration (Tmax) of Psilocin
Time frame: Pre-dose to 8 hours post-dose
Area Under the Curve (AUC₀-₈) for Psilocin
Time frame: Pre-dose to 8 hours post-dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: Undecided
Related trials for PTSD
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
RecruitingPhase 4
The Effects of Orexin Antagonism on Fear Extinction in PTSD
Insomnia, PTSD
Recruiting
Advancing Skills Through Consultation, Education, and Novel Technologies
PTSD - Post Traumatic Stress Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Psychedelic in people with PTSD, run by Scottsdale Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: From dosing to 3-month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.