Clinical TrialChronic PainPsilocybinRecruiting

Psilocybin in Cancer Pain Study

This open-label, single-group assignment trial (n=15) aims to assess the feasibility, safety, and preliminary efficacy of psilocybin-assisted therapy for opioid-refractory pain in patients with advanced cancer.

Target Enrollment
15 participants
Study Type
Phase II interventional
Design
Non-randomized

Detailed Description

Phase 2, open-label, single-center trial evaluating a palliative-care informed psilocybin-assisted psychotherapy regimen for opioid-refractory pain in advanced cancer (n≈15).

Procedures include screening, ECG and blood tests, two preparation sessions, one in-clinic oral psilocybin session, integration sessions (day after and one week after), and follow-up visits through 12 weeks to assess safety, feasibility, and pain outcomes.

Study drug provided by Filament Health; funded by Cy Biopharma and Pancreatic Cancer North America; conducted at Dana-Farber Cancer Institute.

Study Protocol

Preparation

2 sessions

Dosing

1 sessions

Integration

2 sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

Psilocybin

experimental

Single-group assignment: one predetermined oral psilocybin session with preparatory and integration therapy.

Interventions

  • Psilocybin
    via Oral• single dose• 1 doses total

    Oral capsule; predetermined single dose provided by Filament Health.

Participants

Ages
18 – 99
Sexes
Male & Female

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.

Study Details

  • Status
    Recruiting
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment15 participants
  • Timeline
    Start: 2024-01-01
    End: 2026-12-31
  • Compound
    Psilocybin
  • Topic
    Chronic Pain

Locations

Dana-Farber Cancer Institute — Boston, Massachusetts, United States

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