A Phase 2b Randomized Double-blind Placebo-controlled Multi-center study of the Effects of Psilocybin-assisted Psychotherapy on Psychiatric and Existential Distress in Advanced Cancer

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Advanced Cancer
  • Age: Between 21 Year(s) - 100 Year(s)
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Aged = 21
    2. Diagnosis of Advanced Cancer
      Advanced Cancer will be defined as:
      • Solid tumors to include stages 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
    3. Clinically Significant Anxiety
    4. 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
    5. Participants of childbearing potential must agree to practice an effective means of birth control throughout the duration of the study. A person of childbearing potential is anyone assigned female or intersex at birth who has experienced menarche and who has not undergone surgical sterilization (e.g., hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or has not completed menopause. Menopause is defined clinically as 12 months of amenorrhea in a person over age 45 in the absence of other biological, physiological, or pharmacological causes.

You may not be eligible for this study if the following are true:

    1. 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. Some examples include:
      • Congestive heart failure
      • Clinically significant arrhythmias (e.g., ventricular fibrillation, torsades)
      • Recent acute myocardial infarction or evidence of ischemia
      • Malignant hypertension
      • Congenital long QT syndrome
      • Acute renal failure
      • Severe hepatic impairment
      • Respiratory failure
    2. Risk for hypertensive crisis
    3. Significant central nervous system (CNS) pathology. Some examples include:
      • Primary or secondary cerebral neoplasm
      • Epilepsy
      • History of stroke
      • Cerebral aneurysm
      • Dementia
      • Delirium
    4. Primary psychotic or affective psychotic disorders. Some examples include current or past DSM-5 criteria for:
      • Schizophrenia spectrum disorders
      • Schizoaffective disorder
      • Bipolar I with psychotic features
      • Major Depressive Disorder with psychotic features
    5. Family history of first-degree relative with psychotic or serious bipolar spectrum illnesses. Examples include first-degree relative with:
      • Schizophrenia spectrum disorders
      • Schizoaffective disorder
      • Bipolar I disorder with psychotic features
    6. High risk of adverse emotional or behavioral reaction based on investigator’s clinical evaluation. Examples include:
      • Agitation
      • Violent behavior
    7. Active substance use disorders (SUDs) or severe alcohol or drug use disorder (excluding caffeine and nicotine) within the past year
    8. Extensive use of serotonergic hallucinogens (e.g., LSD, psilocybin) defined as:
      • Any use in the last 12 months
      • >25 lifetime uses
    9. Clinically significant suicidality or high risk of completed suicide defined as having any suicidal ideation or thoughts, in the opinion of the study physician or PI, that presents a serious risk of suicidal or self-injurious behavior
    10. History of hallucinogen persisting perception disorder (HPPD)
    11. Concurrent Medications
      • Antidepressants
      • Centrally-acting serotonergic agents (e.g., MAO inhibitors)
      • Antipsychotics (e.g., first and second generation)
      • Mood stabilizers (e.g., lithium, valproic acid)
      • Aldehyde dehydrogenase inhibitors (e.g., disulfiram)
      • Significant inhibitors of UGT 1A0 or UGT 1A10
      • Niacin. Note: If taking any supplement containing niacin, agrees to suspend use for at least five days prior to dosing and for the duration of the study
    12. Have a positive urine drug test including Amphetamines, Barbiturates, Buprenorphine, Benzodiazepines, Cocaine, Cannabis, Methamphetamine, MDMA, Methadone, Opiates (Morphine, Oxycodone), Phencyclidine (PCP), and Tetrahydrocannabinol (THC).
      • Note: Prescribed opiate medications (e.g., cancer-related pain) will be allowed to continue through the study period for participants who have been on a stable dose of such medicine for at least 1 month prior to Screening, as determined during review of concomitant medications
      • Note: Prescribed benzodiazepine medications and non-benzodiazepine sleeping medications will be allowed to continue through the study period for participants who have been on a stable dose of such a medicine for at least 6 weeks prior to Screening, as determined during review of concomitant medications.
      • Note: Participants using cannabis, including legal cannabis, for any purposes must agree to refrain from use beginning at Screening, as confirmed with a negative Baseline drug test, and through to the end of the study.
      • Note: Participants using prescribed psychostimulants (amphetamines and Ritalin), must agree to refrain from use two weeks prior to baseline visit, as confirmed with a negative Baseline drug test, and through to the end of the study.
    13. Have a psychiatric condition judged to be incompatible with establishment of rapport with the study therapists or safe exposure to psilocybin
    14. Participants who are pregnant, as indicated by a positive urine pregnancy test at Screening, Baseline, or prior to dosing on medication administration sessions. Participants who intend to become pregnant during the study or who are currently nursing.
    15. Have an allergy or intolerance to any of the materials contained in either drug product
    16. Be enrolled in another clinical trial assessing intervention(s) for anxiety, depression, and/or existential distress (e.g., pharmacologic or psychotherapeutic interventions)

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