This pilot study will examine the safety, tolerability, acceptability, and efficacy of combination psilocybin + psychotherapy to decrease PTSD symptoms. Participants will be randomized into two different treatment groups, allowing the investigators to directly compare PE augmented with psilocybin and psilocybin-assisted psychotherapy.
Who can participate
Age range
18 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
. Meet criteria for PTSD due to trauma occurring at least 6 months prior based on CAPS-5-R diagnostic scoring rules.
. Willingness of participant to sign a release for the investigators to communicate with their primary care or mental health providers, if indicated
. Are 18 years and older.
. Are able to visually read and understand the English language and give written informed consent.
. Are able to swallow pills.
. Agree to have study visits video and/or audio recorded, including dosing session, Independent Rater assessments, and non-drug psychotherapy sessions.
. Must provide a contact (relative, spouse, close friend, or other support person) who is willing and able to be reached by the investigators in the event of a participant becoming suicidal or unreachable.
. Must agree to inform the investigators within 48 hours of any medical conditions and procedures.
Exclusion criteria
. Are not able to give adequate informed consent.
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
Change in PTSD symptoms based on CAPS-5-R total severity score
Timeframe: Baseline, 1-month post-intervention
2
Change in PCL-5 score
Timeframe: Baseline, 1, 6 and 12 months post-intervention
3
Depression symptoms (PHQ-9)
Timeframe: Baseline, 1, 6 and 12 months post-intervention
. Are currently engaged in compensation litigation whereby financial gain would be achieved from prolonged symptoms of PTSD or any other psychiatric disorders. "Compensation litigation" will not include veterans who are service connected through PTSD or other conditions.
. Are likely, in the investigator's opinion and via observation during the Preparatory Period, to be re-exposed to their index trauma or other significant trauma, lack social support, or lack a stable living situation.
. Have any current problem which, in the opinion of the investigator or Medical Monitor, might interfere with participation.
. Have a family history bipolar disorder type 1 or a psychotic disorder in first degree relatives.
. Have a history of or current bipolar type 1 disorder, or primary psychotic disorder (e.g., schizophrenia), as assessed via DIAMOND and clinical interview, dementia; or intellectual disability.
. Have current major depressive disorder with psychotic features assessed via DIAMOND.
. Have met criteria at any time during their life for hallucinogen substance use disorder.