Pilot Study of Psilocybin-Assisted Therapy for Demoralization in Patients Receiving Hospice Care (NCT04950608) | Clinical Trial Compass
CompletedPhase 2
Pilot Study of Psilocybin-Assisted Therapy for Demoralization in Patients Receiving Hospice Care
United States15 participantsStarted 2022-03-09
Plain-language summary
The overall objective of this study is to develop and pilot test a novel regimen of psilocybin-assisted psychotherapy for demoralization in patients receiving hospice care.
-The name of the study drug involved in this study is Psilocybin
Who can participate
Age range
21 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:
* Patients enrolled in hospice care at home
* Age ≥ 21 years.
* Any terminal illness with respect of exclusion criteria
* Palliative Performance Scale (PPS) ≥ 50 % (see Appendix A)
* Moderate-to-severe demoralization as measured by Demoralization Scale-II ≥ 8
* Significant other or other caregiver present at home the night of study drug administration
* No driving for 24 hours following study drug administration.
* English proficiency
* Ability to understand and the willingness to sign a written informed consent document.
* Psilocybin is very likely to have no genotoxic effects. One study that directly focused on the mutagenic potential of psilocybin did not found this type of toxicity. However, due to the lack of clinical and non-clinical studies on the effects of psilocybin on the developing human fetus, women and men of child-bearing potential and who are sexually active must agree to use an acceptable contraceptive method (hormonal or barrier method of birth control; abstinence) throughout their participation in the study. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of psilocybin administration.
Exclusion Criteria:
* Current General Inpatient (GIP) hos…
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
Number of Participants Screened Per Study Period
Timeframe: Through study completion, through 22 months
2
Eligible Population
Timeframe: Through study completion, over 22 months
3
Number of Participants Enrolled Over Study Period
Timeframe: Through study completion, over 22 months
4
Average Time From Screening to Enrollment
Timeframe: From date of screening until the date of enrollment, assessed up to 12 months
5
Number of Therapy Sessions Completed by Enrolled Participants
Timeframe: Through study completion, a period of 22 months
6
Mean Score of Acceptability Ratings on Reactions to Research Participation Questionnaire Revised (RRPQR)