Clinical trial · Interventional
Psilocybin Combined With Multidisciplinary Palliative Care in Demoralized Cancer Survivors With Chronic Pain
The Safety, Feasibility, and Acceptability of Psilocybin Combined With Multidisciplinary Palliative Care in Demoralized Cancer Survivors With Chronic Pain (P-PC)
NCT05506982CI-TRIAL-00092481completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This phase I trial evaluates the side effects of psilocybin and how well it works under supportive care conditions in cancer survivors living with demoralization and chronic pain. Cancer patients often experience demoralization, which is characterized by feelings of hopelessness, loss of meaning, and existential distress. Psilocybin psychotherapy, together with multidisciplinary palliative and supportive care, may help treat the anxiety, depression, and chronic pain felt by cancer survivors - defined here as cancer patients from time of diagnosis through the end-of-life.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematopoietic and Lymphoid Cell Neoplasm | Hematopoietic and Lymphoid Cell Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Malignant Solid Neoplasm | Malignant Solid Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Psilocybin | Drug | — | UNRESOLVED |
| Psychotherapy | Behavioral | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Supportive care (psilocybin, observation)
- description
- Patients receive psilocybin PO and undergo observation for up to 24 hours on day 14.
- interventionNames
- Drug: Psilocybin
- Behavioral: Psychotherapy
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
Primary outcomes (2)
- measure
- Incidence Of Treatment-Related Medical Grade 3 Or Higher Or Psychiatric Grade 4 Or Higher
- timeFrame
- Up to 42 days
- description
- Adverse events are graded according to Common Terminology Criteria for Adverse Events. Descriptive statistics will summarize the incidence and duration of adverse events, with the primary outcome of interest being the incidence of medical Grade 3 or higher or psychiatric Grade 4 or higher Common Terminology Criteria for Adverse Events considered by the PI to be treatment-related occurring by day 42. These events will be evaluated by adverse events, vital signs, ECG, and laboratory findings. A successful outcome is no medical or psychiatric Grade 4 adverse events or higher.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 26 Years
Show eligibility criteria text
Inclusion Criteria: * Signed informed consent form (ICF) * Diagnosis of solid or liquid cancer made \>= 1 year at any stage in cancer survivorship (specifically, active cancer treatment or no cancer-directed therapy either in clinical remission or with advanced disease) * Prognosis of greater than six months as determined by their primary oncologist * Moderate-to-severe demoralization (score of \>= 10 on the Demoralization Scale-II \[DS-II\]) * Chronic pain (pain lasting \> 3 months) per patient report and score of \>= 5 for average pain level on Brief Pain Inventory * Age \>= 26 years old and ≤85 years old * Availability of a friend or family member into whose care the participant can be released following the drug administration session Exclusion Criteria: * Pregnancy or breastfeeding * Women of childbearing potential (i.e., not permanently sterilized, not postmenopausal) who decline to use a highly effective dual contraceptive method for the duration of the study. Dual contraceptive method use is defined by a use a barrier contraceptive in addition to another method to prevent pregnancy, including sterilization, hormonal methods, intrauterine devices, and hormonal pills. * Age \< 26 years old and \> 85 years old * Poor functional status (Eastern Cooperative Oncology Group \[ECOG\] score of \>= 2) * Major cognitive impairment as determined by principal investigator * Non-fluency in the English language * Personal history of a psychotic disorder or Bipolar disorder type I/II * Active suicidal ideation with intent in the last 3 months (Columbia Suicide Severity Rating Scale suicidal ideation score \> 3) or any suicide attempt in the past year * Current substance use disorder (i.e., present in last six months), of greater than mild severity as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM-V) * History of a seizure disorder in adulthood * Active central nervous system (CNS) metastases or symptomatic CNS infection * Uncontrolled hypertension (mean blood pressure (mmHg) exceeding 139 systolic and 89 diastolic) and heart rate exceeding 90 beats per minute * Clinically significant cardiovascular disease (coronary artery disease, congestive heart failure, arrhythmia, or QTc\>450ms) * Supplemental oxygen requirement * Body mass index =\< 18 * Renal insufficiency as evidenced by creatinine clearance (CrCl) \< 30 mL/min * Concomitant use of drugs known to interact with psilocybin (probenecid, diclofenac) * Consistent use of serotonergic drugs including selective serotonin reuptake inhibitors (SSRIs), serotoninnorepinephrine reuptake inhibitors (SNRIs), or efavirenz, as well as monoamine oxidase inhibitors (MAOIs). Subjects using any other antidepressant, stimulant, or antipsychotic medications on Day 0 (baseline visit) may be allowed to enroll in the study if they elect to taper off the medications under medical supervision by the PI and the study psycho-oncologist (PO) by the day prior to the baseline visit * Considered by the principal investigator to be inappropriate for the study due to safety concerns or to be unlikely to complete the protocol
References
Publications (0)
Data not yet available
No reference posted for this study.