NCT04950608

✓ Unanimous Initial: outpatient

✓ Unanimous Initial: outpatient Requery: outpatient — Participants are hospice patients receiving care at home, which is an outpatient setting, and the exclusion criteria specifically excludes patients with 'Current General Inpatient (GIP) hospice status.' Thinking: outpatient — Patients must be enrolled in hospice care at home, with inpatient hospice status explicitly excluded as a criterion.

✓ Unanimous Initial: inpatient Requery: inpatient — The intervention is delivered to patients receiving hospice care, which involves an inpatient setting as these patients are typically admitted to a hospice unit for end-of-life care. Thinking: outpatient — Participants are home hospice patients (inclusion requires hospice care at home and excludes inpatient hospice), so the intervention is delivered in an outpatient/home setting.

✓ Unanimous Initial: home care

✓ Unanimous Initial: home care Requery: hospice — The study specifically targets patients enrolled in hospice care and delivers the psilocybin-assisted therapy intervention in the hospice care setting.

✓ Unanimous Initial: hospice Requery: hospice — The intervention is specifically designed for and delivered to patients enrolled in hospice care at home, focusing on terminally ill patients receiving hospice services.

✓ Unanimous Initial: no Requery: no — The study tests psilocybin-assisted psychotherapy as the intervention in hospice patients, making palliative care the setting rather than the intervention itself.

✓ Unanimous Initial: yes Requery: no — This study tests psilocybin-assisted psychotherapy as the intervention in hospice patients, where hospice care is the setting but not the experimental intervention being evaluated.

✓ Unanimous Initial: no Requery: no — The trial focuses on psilocybin-assisted therapy, not palliative care as an intervention.

✓ Unanimous Initial: not yet FDA/EMA approved Requery: not yet FDA/EMA approved — The detailed description explicitly states that psilocybin is an investigational drug that has not been approved by the U.S. Food and Drug Administration (FDA) as a treatment for any disease.

✓ Unanimous Initial: controlled substances Requery: controlled substances — Psilocybin is a controlled substance classified as a Schedule I drug by the DEA, and this study involves its administration in a clinical trial setting. Thinking: not yet FDA/EMA approved — The study explicitly states psilocybin is an 'Investigational' drug that has not been approved by the FDA as a treatment for any disease.

✓ Unanimous Initial: controlled substances Requery: not yet FDA/EMA approved — Psilocybin is classified as an investigational drug, not yet approved by the FDA for the intended use in this study. Thinking: not yet FDA/EMA approved — Psilocybin is an investigational psychedelic drug that has not received FDA or EMA marketing approval for any indication.