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Tests treatment safety and results for PTSD
Official title Safety and Preliminary Efficacy of Organic Whole Psilocybin-Containing Mushrooms to Treat Patients Suffering From PTSD
ClinicalTrials.gov ID: NCT07275970
What this study is testing
What is Psychedelic?
Psychedelic is an investigational medicine, being studied as a potential treatment for ptsd.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- Determination of at least one traumatic event as determined by the LEC-5
- A score of at least 33 on the PCL-5
You likely can't join 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...
See the full eligibility criteria
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- Be proficient in reading and writing in English and able to effectively communicate with site staff.
- Agree not to participate in any other treatment clinical trials during the study.
- 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 study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.