Mindfulness-based Psilocybin Therapy for PTSD (NCT07104916) | Clinical Trial Compass
RecruitingPhase 2
Mindfulness-based Psilocybin Therapy for PTSD
United States30 participantsStarted 2026-07-01
Plain-language summary
The goal of this study is to learn how psilocybin delivered with mindfulness-based therapy may help symptoms of posttraumatic stress disorder (PTSD). This is an assessor-blinded, randomized, controlled study in participants with PTSD. The study will investigate the changes in brain activity, connectivity, and microstructural neuroplasticity assessed using EEG/EMG and multimodal MRI measures after administration of one oral dose of psilocybin, accompanied either with standard "psychological support" only; or with standard support plus Mindfulness-based Cognitive Therapy (MBCT).
Who can participate
Age range
21 Years – 65 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
. Participant is assigned female or male at birth.
. Participant is aged between 21 to 65 years, inclusive, at Screening. This is to reduce variability in brain function and connectivity in this small pilot study that may be related to age / developmental factors in persons under 21 and over 65.
. Participant has a BMI of 18 to 30 kg/m2, inclusive, at Screening.
. Participant has a diagnosis of PTSD (as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th edition \[DSM-5\] established through a clinician interview that includes the Mini-International Neuropsychiatric Interview \[MINI\]) and the Clinician Administered PTSD Scale for DSM-5 (CAPS-5).
. PTSD severity moderate to severe based on CAPS-5 score ≥25, and with moderate depression MADRS ≥20.
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.
1This is a Phase 2 trial, which means it's still in relatively early stages of testing — can you help me understand what that means for how much is already known about the safety and effectiveness of psilocybin for PTSD specifically?
2The trial seems focused heavily on brain imaging and measurements like fMRI and startle response rather than symptom relief as a main goal — does that mean the primary purpose is to understand how psilocybin affects the brain, and would I still receive actual treatment aimed at helping my PTSD symptoms?
3Since the trial involves a single dose of psilocybin combined with mindfulness-based therapy, how does that compare to the standard treatment options I currently have available for PTSD, and is there a reason to consider this before or after trying those?
4The trial is measuring things like brain connectivity and event-related potentials — what does participating actually look like day-to-day, and how many visits, scans, or sessions would I need to commit to?
5I also have depression alongside my PTSD — does this trial's focus on both conditions mean my depression would be monitored and addressed, or is PTSD the main condition being treated here?
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
Changes in parameter estimate of regional brain activity measured by fMRI after one dose of psilocybin in participants with PTSD
Timeframe: Between Baseline and Time point 24 hours and 28 days post-Investigational Product
2
Changes in region-to-region connectivity measured by fMRI after PAT with one dose of psilocybin in patients with PTSD
Timeframe: Between Baseline and Time point 24 hours and 28 days post-Investigational Product
3
Changes in event related potentials (ERP) after PAT with one dose of psilocybin in participants with PTSD
Timeframe: Between Baseline and Time point 24 hours and 28 days post-Investigational Product.
4
Changes in acoustic startle electromyographic (EMG) response after PAT with one dose of psilocybin in patients with PTSD
Timeframe: Between Baseline and Time point 24 hours and 28 days post-Investigational Product
. Participants capable of producing sperm must use a condom during the trial and for 3 months after their dose of trial medication, if their partner is a person of childbearing potential. In addition, their partner of childbearing potential must also use a highly effective method of contraception (i.e., failure rate less than 1% when used consistently and correctly) from dosing until 3 months following dosing. Condoms alone and abstinence are not considered highly effective methods of contraception.
. Participants of childbearing potential must agree to use a highly effective method of contraception (i.e., failure rate less than 1% when used consistently and correctly) in combination with use of a condom by a partner who is capable of producing sperm, during the trial and for 3 months after dosing. Condoms alone and abstinence are not considered highly effective methods of contraception. Such participants must have a negative pregnancy test at Screening and Day 1.
. Participants of non-childbearing potential who are or were capable of producing eggs (ova) must be postmenopausal or permanently sterile following hysterectomy, bilateral salpingectomy or bilateral oophorectomy. Postmenopausal is defined as spontaneous amenorrhea for at least 12 months, and a serum follicle stimulating hormone (FSH) level in the menopausal range, unless the participant is taking hormone replacement therapy or is using hormonal contraception.
Exclusion criteria
. Cardiovascular disease, including coronary artery disease (CAD) and congestive heart failure (CHF). This is an FDA requirement.
. Current or previously diagnosis of schizophrenia spectrum or other psychotic disorders, including schizophrenia, schizoaffective disorder, schizotypal disorder, schizophreniform disorder or brief psychotic disorder; current or previous history of bipolar disorder, or current personality disorder (as determined by MINI at Screening). This is an FDA requirement.
. Clinically significant risk of suicidality, as determined through a comprehensive psychiatric interview that incorporates the Columbia Suicide Severity Rating Scale (CSSRS); a score of 4 or higher on the suicidal ideation subscale of C-SSRS (past 6 months) or any suicidal behaviour (lifetime), would be exclusionary.
. History of substance use disorder within the 12 months, as assessed by a structured clinical interview (Mini International Neuropsychiatric Interview \[MINI\], Version 7.0.2) or determined by self-report, or intake of \>21 units of alcohol weekly, and the inability to refrain from alcohol use from 48 hours before Screening and each scheduled visit until discharge from the study site. One unit is equivalent to a 285 mL glass of full-strength beer or 1 (30 mL) measure of spirits or 1 glass (100 mL) of wine.
. Currently receiving a monoamine oxidase inhibitor, tricyclic antidepressant, other non-SSRI or non-SNRI antidepressants (e.g. bupropion, mirtazapine, etc), an antipsychotic or a mood stabilizer.
. Exposure to psilocybin, or any other psychedelics, such as ayahuasca, mescaline, LSD or peyote more than 10 times in the last 10 years, or any psychedelic use within 6 months prior to Screening.
. Use of psychotropic medicine/supplement (or medicine/supplement that would interact with psilocybin) including buspirone and venlafaxine, during the 28 days before dosing. Participants may take a stable chronic dose of other SSRI antidepressant medication(s) and/or sedatives/hypnotics. The Investigator and study team may review medication on a case-by-case basis to determine if its use would compromise participant safety or interfere with study procedures or data interpretation.
. Family history of schizophrenia or schizoaffective disorder (first degree relatives), or bipolar disorder type 1 (first degree relatives).