Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Psilocybin · 1 trial · 8 indications
This measurement will assess enrollment feasibility based on the screening log.
Number of screened hospice patients who met pre-eligibility criteria and were approached for consent
This measurement will assess enrollment feasibility based on the screening log.
This measurement will assess enrollment feasibility based on the screening log.
Therapy sessions included 5 sessions: 2 preparation visits (V1 and V2), dosing (V3) and 2 integration visits (V4 and V5)
The RRPQ-R is a validated 23-item instrument designed to assess participants' experiences and perceptions of research participation. It comprises five subscales: participation (7 items, range 7-35), personal benefit (5 items, range 5-25), emotional reactions (6 items, range 6-30), perceived drawbacks (3 items, range 3-15), and global evaluation (2 items, range 2-10). Items are rated on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree). Higher scores on participation, personal benefit, and global evaluation indicate more positive perceptions, while higher scores on emotional reactions and perceived drawbacks reflect greater negative emotional or practical impact. A total score can be calculated by summing across all items (range 23-115), with higher scores reflecting more favorable overall experiences of research participation.
| Arm | Type | Description |
|---|---|---|
| PATH | EXPERIMENTAL | The research study procedures include screening for eligibility, and study intervention including preparation, evaluations, one psilocybin session and follow up visits. -The treatment regimen consists of a single administration of psilocybin 25 mg orally combined with a supportive psychotherapy including 2 preparation sessions and 2 integration sessions |
| Name | Type | Description |
|---|---|---|
| Psilocybin | DRUG | Oral, single administration, dosage 25 mg orally |
| Psychotherapy | BEHAVIORAL | The treatment regimen consists of a single administration of psilocybin orally combined with a supportive psychotherapy including 2 preparation sessions and 2 integration sessions |
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...
Psilocybin is being studied for use in hospice care to treat demoralization in patients with terminal illness, including terminal cancer. It is administered as psilocybin-assisted therapy, combining the drug with psychotherapy. The investigational treatment is currently in Phase 2 clinical development and is not yet approved.
Psilocybin is a small molecule that acts as a psychedelic compound. In the context of the hospice study, it is used to address demoralization, a condition of hopelessness and loss of meaning, in terminally ill patients. The therapy is paired with psychotherapy to support patients facing end-of-life psychological distress.
Psilocybin is being developed by Smith & Nephew SNATS, Inc., a company listed on the stock exchange under the ticker SNN. The company is conducting clinical research on psilocybin-assisted therapy for demoralization in hospice patients with terminal illness.
Psilocybin is in Phase 2 clinical development for the treatment of demoralization in hospice patients. It is an investigational drug, meaning it has not been approved by regulatory authorities. The Phase 2 study has been completed, and the drug remains under evaluation for this indication.
Psilocybin has been studied in one clinical trial, NCT04950608, titled 'Pilot Study of Psilocybin-Assisted Therapy for Demoralization in Patients Receiving Hospice Care.' This Phase 2 trial enrolled 15 participants in the United States and has been completed. The study was uncontrolled, meaning there was no comparison group.
Psilocybin is the active drug, while psilocybin-assisted therapy refers to the treatment approach that combines psilocybin with psychotherapy. In the hospice study, the drug is administered as part of a therapeutic session to address demoralization in terminally ill patients, including those with cancer.