Effects of Repeated Psilocybin Dosing in OCD (NCT05370911) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Effects of Repeated Psilocybin Dosing in OCD
United States28 participantsStarted 2023-07-20
Plain-language summary
This study aims to investigate the effects of repeated dosing of oral psilocybin on obsessive-compulsive disorder (OCD) symptomatology in a randomized, waitlist-controlled design with blinded independent ratings, and assess psychological mechanisms that may mediate psilocybin's therapeutic effects on OCD.
Who can participate
Age range
18 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
. Primary DSM-5 diagnosis of OCD, with Y-BOCS-II score of 26 or greater at screening
. Failed at least one medication and/or therapy trial of standard care treatment for OCD
. English fluency
. Agree to sign a medical release for investigators to communicate directly with participants' providers to confirm medication and psychotherapy histories or arrange contingencies in event of crises.
. Agree to provide an adult contact (relative, spouse, close friend or other caregiver) who is willing and able to be reached by the PI and/or study personnel in the event of an emergency, and who can provide transportation for study visits and independently comment on any changes in the participant's mood or behavior after each administration of psilocybin.
. Agree to commit to all study procedures.
. Ability to orally ingest pills for psilocybin dosing visits.
. Agree to adhere to lifestyle and medication modifications.
Exclusion criteria
. Personal or immediate (first-degree relative) family history of formally diagnosed schizophrenia or other psychotic disorders, or bipolar I/II disorder
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 Yale-Brown Obsessive-Compulsive Scale-Second Edition (Y-BOCS-II) Severity Scale total score from baseline at 4 days post-second dose