Psilocybin Combined with Multidisciplinary Palliative Care in Demoralized Cancer Survivors with Chronic Pain

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 caregiver to complete caregiver-related assessments
• 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 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 >= 3)
• Major cognitive impairment as determined by principal investigator
• Non-fluency in the English language
• Personal or family (first-degree relative) 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 corrected QT [QTc] > 450 ms)
• 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), serotonin-norepinephrine reuptake inhibitors (SNRIs), or efavirenz, as well as monoamine oxidase inhibitors (MAOIs). Subjects using any antidepressant, stimulant, or antipsychotic medication 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 principal investigator (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 or to be unlikely to complete the protocol