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 range19 Years – 85 Years
SexALL
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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…