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Psilocybin Therapy in Advanced Cancer

StatusRecruiting
PhasePhase 2/3
Started2023-05-24
View on ClinicalTrials.gov ↗

Amendment history

2025-12-02
Study Status, Study Design v10
Enrollment target300→200
2025-01-14
Study Status, Contacts/Locations v9
Study sitescontacts updated at 1 of 2 sites
2025-01-13
Study Status, Contacts/Locations v8
Study sitescontacts updated at 1 of 2 sites
2024-04-30
Study Status v7
Start date2023-06-15→2023-05-24
2024-01-24
Study Status, Contacts/Locations v6
Study sitesdetails revised at 1 of 2 sites
Show 5 earlier versions
2023-09-13
Study Status, Outcome Measures v5
Start date2023-05-04→2023-06-15
Secondary endpointsdetails revised at 3 of 32 entries
2023-05-04
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v4
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-05-01→confirmed 2023-05-04
Study sitesdetails revised at 2 of 2 sites
2023-04-17
Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v3
Start date2023-01-31→2023-05-01
InterventionsPsilocybin 1 mg (Drug), Psilocybin 25 mgs (Drug), Psychotherapy (Behavioral)→Niacin 100mg (Drug), Psilocybin 25 mgs (Drug), Psychotherapy (Behavioral)
Eligibility criteria+3,410 characters
Inclusion Criteria: Aged ≥ 21 Diagnosis of Advanced (i.e.Cancer defined as: Solid tumors to include stage 3 or 4, solidmetastatic tumors)illness, Canceror recurrent illness Hematologic malignancies to include, but not limited to, Stage 3 or 4 non-Hodgkins lymphoma, late-stage multiple myeloma or second-line therapy for multiple myeloma, and all forms of acute myeloid leukemia Functional Status defined as: Eastern Cooperative Oncology Group (ECOG) ≤2 and Palliative Performance Scale (PPS) ≥60% Clinically significant Depression/Anxiety, with Hospital Anxiety and Depression (HADS) Total score >12 [...] [...]
Secondary endpoints22 to 32 entries
Change in HealingStructured ExperienceInterview ofGuide Allfor Lifethe StressorsMontgomery-Asberg Depression Rating Scale (NIH-HEALSMADRS): SIGMA Score Change in HealingStructured ExperienceInterview ofGuide Allfor Lifethe StressorsMontgomery-Asberg Depression Rating Scale (NIH-HEALSMADRS): SIGMA Score Change in HealingStructured ExperienceInterview ofGuide Allfor Lifethe StressorsMontgomery-Asberg Depression Rating Scale (NIHMADRS): SIGMA Score Changes in Demoralization Scale Version II (DS-HEALSII) Score Changes in Demoralization scaleScale Version II (DS-II) Score Changes in Demoralization [...]
Primary endpoints2 to 1 entries
Change in GRID-HamiltonStructured DepressionInterview RatingGuide Scalefor (GRID-HAMD-17) Score Change inthe Hamilton Anxiety Scale Ham A (GRID-HamHAM-A): SIGH-A Score
Study description-40 characters
[...] ilocybin-assisted psychotherapy (PAP) to treat psychiatric (depressionanxiety, anxietydepression) and existential distress (demoralization, death anxiety), [...] d quality-of-life (QOL), in 200 outpatients with late-stage (stage 3 or 4)advanced cancer. The study will assess the strength and durability o [...] ng a single 25mg oral 'high' dose of psilocybin to a single 1mg 'very low' (clinically non-therapeutic)100mg dose of niacin (active control psilocybinplacebo), both delivered in conjunction with a psychotherapy platform.
Study sitescontacts updated at 1 of 2 sites
2022-12-07
Study Status v2
Start date2022-11-01→2023-01-31
2022-09-14
Study Status, Contacts/Locations v1
Study sitescontacts updated at 2 of 2 sites
2022-05-26
Original filing
The purpose of this research is to study the safety and effects of single-dose psilocybin 25mg versus an active placebo (single dose niacin 100mg) in the treatment of anxiety, depression, and existential distress (i.e., loss of meaning and hope; fear of death) in advanced cancer (i.e., stage 3 or 4). Study medications will be administered in conjunction with brief psychotherapy that is designed to treat anxiety, depression and existential distress in advanced cancer.
Trial Details
NCT Number NCT05398484
Lead Sponsor NYU Langone Health
Collaborators: National Cancer Institute (NCI)
Conditions Advanced Cancer
Enrollment 200 participants
Start Date 2023-05-24
Primary Completion 2027-01-01 (estimated)
Study Completion 2027-01-01 (estimated)
Updated on ClinicalTrials.gov 2025-12-04