Psilocybin in Cancer Pain Study (NCT06001749) | Clinical Trial Compass
RecruitingPhase 2
Psilocybin in Cancer Pain Study
United States15 participantsStarted 2024-09-23
Plain-language summary
The overall objective of this study is to assess the feasibility, safety and preliminary efficacy of psilocybin-assisted therapy to alleviate opioid-refractory pain in patients with advanced-cancer.
The name of the study intervention used in this research study is:
Psilocybin (a tryptamine derivative)
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:
* Participants must be 18 year old or older;
* Participants must have advanced cancer, defined as a cancer that is unlikely to be cured or controlled with treatment;
* Participants must have progressed on or be intolerant to approved therapies with a known clinical benefit (unless it is documented that they have refused such treatments);
* Participants must evaluate their average pain on BPI Severity Scale ≥ 4/10 over the past week;
* Participants must receive chronic opioid pharmacotherapy for pain with an Oral Morphine Equivalent (OME) ≥ 200mg/day;
* Participants must have been seen by a palliative care clinician either at DFCI, MGH or associated satellites in the last three months;
* Participants must have an ECOG Performance Status ≤ 2
* Participants must meet the following organ and marrow function on their last available bloodwork as defined below:
* Platelets ≥ 50,000/mcL
* AST(SGOT)/ALT(SGPT) ≤ 5 × institutional ULN
* Participants must be able to understand and willing to sign a written informed consent document
* Participants must be able to swallow pills.
* Participants 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.
* Participants must agree to inform the investigators within 48 hours of any new medical conditions and procedures.
* Participants must agree to the following lifestyle modif…
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.