Palliadelic Treatment to Reduce Psychological Distress in Persons With Advanced Gastrointestinal … (NCT05220046) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Palliadelic Treatment to Reduce Psychological Distress in Persons With Advanced Gastrointestinal Cancers
United States24 participantsStarted 2023-04-10
Plain-language summary
The primary objective of this study is to evaluate the ability to recruit and retain participants, and to successfully conduct a psilocybin-based protocol, for a study of the treatment of distress related to stage IV or inoperable gastrointestinal cancers. Secondary objectives include pre/post, and longitudinal measurement of distress in intervention participants and a paired family member who is in an observational arm.
Who can participate
Age range
19 Years – 85 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:
* Between the ages of 19 and 85
* Has stage IV or unresectable GI malignancy
* Resides within a 170-mile radius of Omaha, NE
* Speaks English
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-3
* Life expectancy ≥ 8 weeks as determined by referring oncologist
* Ability to provide written informed consent and comply with study procedures
* Awareness of the neoplastic and likely incurable nature of his/her disease
* Has one family member willing to participate in measures
* Agreeable to using an adequate method of contraception or birth control from the time of enrollment to 24 hours following the psilocybin session (male and female participant of childbearing potential, defined as age \<55 and menses within the prior 2 years with intact ovaries and uterus)
* Negative pregnancy test result (female participants)
Exclusion Criteria:
* Long-term or unstable psychiatric illness that would prevent safe cessation of psychotropic drugs including MAOIs, lithium, or anti-psychotics
* Severe symptoms of depression or anxiety warranting immediate impatient evaluation or treatment
* High-risk of suicide, as measured by Columbia Suicide Severity rating Scale
* Current or prior history of schizophrenia, psychotic disorder (unless substance induced or due to medical condition) or bipolar I or II disorder
* First-degree family member with schizophrenia, psychotic disorder (unless substance induced or due to medical condition) or bipolar I or 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.