NeuroGuard: Psilocybin Trial for Preventing Chemo-induced Neuropathy
United States83 participantsStarted 2026-11-04
Plain-language summary
To learn if psilocybin can help to prevent or decrease the severity of chemotherapy-induced peripheral neuropathy (CIPN) in patients who are receiving chemotherapy for the treatment of breast, colorectal, and In this study, psilocybin is being compared to standard supportive care and to a placebo.
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.
Exclusion criteria
2. Inhibitors of monoamine oxidase, UGT1A9, 1A10, and aldehyde or alcohol dehydrogenase should be discontinued 5 half-lives prior to active dose of psilocybin.
3. Eligible subjects will have a third-party transportation by a licensed driver (e.g. friend, family or a driver) after the psilocybin session is complete. If a driver is used, a friend or family member must accompany them in the vehicle home
4. Participants should agree to refrain from driving, operating heavy machinery, or engaging in safety-sensitive activities for the remainder of the day following psilocybin administration (for both 25mg or subperceptual 1mg placebo).
5. Fluent in English
. History of another primary malignancy, except for:
. Malignancy treated with curative intent and no active disease for ≥ 5 years before the first dose of study drug, with low potential risk for recurrence.
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.
1Since this trial is in Phase 2 and hasn't started recruiting yet, what does that mean for how much is already known about whether psilocybin is safe for people going through chemotherapy — and would waiting for more data be a reasonable option for me?
2Given that the primary thing this trial is measuring is safety and side effects rather than whether it actually works, how should I weigh that when deciding if this is the right path compared to standard approaches for managing chemo-induced neuropathy?
3Psilocybin is a psychedelic substance — are there any risks or interactions I should know about given my specific chemotherapy regimen, medical history, or any medications I'm currently taking?
4Since the trial isn't recruiting yet, what would the realistic timeline look like before I could even potentially participate, and could waiting affect my neuropathy treatment in the meantime?
5Are there already established or standard-of-care options for preventing or treating chemo-induced neuropathy that I should consider first, before thinking about enrolling in an early-phase experimental trial like this one?
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
Safety and adverse events (AEs)
Timeframe: Through study completion; an average of 1 year