Clinical TrialPalliative & End-of-Life DistressPsilocybinPlaceboRecruiting

Psilocybin Therapy in Advanced Cancer

Double-blind, randomized, parallel Phase II/III RCT (n≈300 estimated) comparing a single 25 mg oral dose of psilocybin plus psychotherapy versus a single 100 mg niacin active placebo plus psychotherapy in outpatients with advanced cancer to treat anxiety, depression and existential distress.

Target Enrollment
300 participants
Study Type
Phase II/III interventional
Design
Randomized, double Blind

Detailed Description

Multi-centre, double-blind, randomized parallel design testing single-dose psilocybin (25 mg) against an active placebo (niacin 100 mg), both delivered with a manualised psychotherapy platform in patients with stage 3–4 or advanced cancer.

The psychotherapy platform includes approximately 6 hours of preparatory therapy prior to dosing and 8 hours of integration therapy after dosing; outcomes include measures of anxiety, depression, demoralisation, death anxiety and quality of life.

Study Protocol

Preparation

sessions
360 min each

Dosing

1 sessions

Integration

sessions
480 min each

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

Psilocybin + therapy

experimental

Single 25 mg oral psilocybin with manualised psychotherapy platform (preparation and integration).

Interventions

  • Psilocybin25 mg
    via Oral• single dose• 1 doses total

    One 25 mg capsule administered with water.

  • Compound

    Manualised psychotherapy platform (6 hours preparatory prior to dosing; 8 hours integration following dosing).

Niacin + therapy

active comparator

Single 100 mg niacin active placebo with the same manualised psychotherapy platform.

Interventions

  • Placebo100 mg
    via Oral• single dose• 1 doses total

    Niacin 100 mg active placebo.

  • Compound

    Manualised psychotherapy platform (6 hours preparatory prior to dosing; 8 hours integration following dosing).

Participants

Ages
21 – 99
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Aged ≥ 21
  • Diagnosis of Advanced Cancer defined as:
  • * Solid tumors to include stage 3 or 4, metastatic illness, or 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 Anxiety defined as SIGH-A >17 at Screening
  • Have an identified support person: agree to be accompanied home (or to an otherwise safe destination) by the support person, or another responsible party, following dosing
  • Participants of childbearing potential must agree to practice an effective means of birth control throughout the duration of the study.

Exclusion Criteria

  • Exclusion Criteria:
  • Unstable medical conditions or serious abnormalities of complete blood count, chemistries, or ECG that in the opinion of the study physician would preclude safe participation in the trial (examples: congestive heart failure; clinically significant arrhythmias or ECG abnormality such as QTc >450; recent acute myocardial infarction or evidence of ischemia; malignant hypertension; congenital long QT syndrome; acute renal failure; severe hepatic impairment; respiratory failure)
  • Risk for hypertensive crisis defined as Screening, Baseline, and Medication Session (prior to dosing) Blood Pressure >140/90 mmHg
  • Significant central nervous system (CNS) pathology (examples: primary or secondary cerebral neoplasm; epilepsy; history of stroke; cerebral aneurysm; dementia; delirium)
  • Primary psychotic or affective psychotic disorders (examples: schizophrenia spectrum disorders; schizoaffective disorder; bipolar I with psychotic features; major depressive disorder with psychotic features)
  • Family history of first-degree relative with psychotic or serious bipolar spectrum illness
  • High risk of adverse emotional or behavioral reaction based on investigator's clinical evaluation (examples: agitation; violent behaviour)
  • Active substance use disorders within the past year (excluding caffeine and nicotine)
  • Extensive use of serotonergic hallucinogens (any use in the last 12 months or >25 lifetime uses)
  • Clinically significant suicidality or high risk of completed suicide (active suicidal behaviour as assessed by C-SSRS; history of suicide attempt(s) within the past year; any suicidal ideation or thoughts presenting serious risk)
  • History of hallucinogen persisting perception disorder (HPPD)
  • Cognitive impairment as defined by MoCA < 23
  • Concurrent medications (examples: antidepressants; centrally-acting serotonergic agents including MAO inhibitors; antipsychotics; mood stabilizers; disulfiram; significant inhibitors of UGT 1A0 or UGT 1A10; niacin supplements must be suspended at least five days prior to dosing)
  • Positive urine drug test for listed substances (with exceptions for stable prescribed opioids or certain stable benzodiazepines per protocol)
  • Psychiatric condition judged incompatible with rapport with study therapists or safe exposure to psilocybin
  • Pregnancy or nursing; intention to become pregnant during study
  • Any other clinical or safety finding making participant unsuitable for the study as judged by PI

Study Details

Study Team

Sponsors & Collaborators

Locations

University of Colorado Anschutz Medical campus (CU AMC) — Aurora, Colorado, United States
NYU Langone Health — New York, New York, United States

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