Psilocybin in Cancer Pain Study

Participants

Ages

18 – 99

Sexes

Male & Female

BMI

Psychosis History

Inclusion Criteria

Inclusion Criteria:
Participants must be 18 years of age or older.
Advanced cancer (unlikely to be cured or controlled with treatment).
Progressed on or intolerant to approved therapies with known clinical benefit (unless refusal documented).
Average pain on BPI Severity Scale ≥ 4/10 over the past week.
Receiving chronic opioid pharmacotherapy with Oral Morphine Equivalent (OME) ≥ 200 mg/day.
Seen by a palliative care clinician at DFCI, MGH, or associated satellites in the last three months.
ECOG Performance Status ≤ 2.
Adequate organ and marrow function on most recent bloodwork: Platelets ≥ 50,000/mcL; AST/ALT ≤ 5× institutional ULN.
Able to understand and willing to sign informed consent; able to swallow pills.
Provide a contact person reachable if participant becomes suicidal or unreachable.
Agree to inform investigators within 48 hours of new medical conditions or procedures.
Agree to lifestyle modifications (diet, withholding certain medications prior to sessions, be driven home after sessions, commit to dosing, therapy, and study procedures).

Exclusion Criteria

Exclusion Criteria:
Concurrent cytotoxic chemotherapy or radiation within 4 weeks or planned within 6 weeks that may impair function or affect outcomes.
Conditions impairing oral intake or absorption.
Inability to give adequate informed consent.
Significant suicide risk (suicidal ideation with intent and/or plan on C-SSRS within past 6 months or at screening).
History or current primary psychotic disorder, MDD with psychotic features, bipolar I disorder, or dissociative identity disorder; ongoing substance use disorder (active in past year).
Concomitant medications with significant interaction potential that cannot be tapered (e.g., serotonergic antidepressants, SNRIs, TCAs, efavirenz, serotonergic supplements, MAO inhibitors, antipsychotics, mood stabilizers, disulfiram, significant UGT inhibitors).
Evidence/history of significant uncontrolled hematological, endocrine, cerebrovascular, cardiovascular, pulmonary, renal, gastrointestinal, immunocompromising, or neurological disease (including seizure disorder) judged to increase risk.
Brain tumors or untreated brain metastases.
Lab abnormalities contributing to somnolence, confusion, or delayed metabolism of psilocybin, or severe lab abnormalities (CTCAE grade ≥3).
Cirrhosis or liver failure.
Uncontrolled hypertension (≥140/90 mmHg on three occasions) or heart rate >100 bpm on three occasions.
History of ventricular arrhythmia (excluding occasional PVCs without ischemic heart disease) or Wolff-Parkinson-White not successfully eliminated.
History of arrhythmia within 12 months unless successfully treated; other risk factors for Torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).
Marked baseline QTcF prolongation (>450 ms males; >460 ms females) on triplicate ECGs at screening.
Pregnant or nursing women or women able to become pregnant not using effective contraception.
Hypersensitivity to any ingredient of the investigational product.

Company

Product

Legal

Detailed Description

Study Protocol

Preparation

Dosing

Locations

Integration

Therapeutic Protocol

Study Arms & Interventions

Psilocybin

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details