Phase
Condition
Neoplasms
Metastatic Melanoma
Metastatic Cancer
Treatment
Psilocybin
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
>18 years of age;
Ability to speak and read English (patient to provide written informed consent andparticipate in PEARL intervention, as determined by study personnel);
No cognitive impairment indicated in medical record or by attending oncologist orpalliative care physician;
Confirmed diagnosis of stage IV solid tumour cancers, sarcoma, endocrine, melanomacancers, or stage 4 lymphoma with expected survival of greater than 6 months asdetermined by their oncologist or palliative care physician;
At least mild depressive symptoms, defined as >8 on the Patient HealthQuestionnaire-9 (PHQ-9) (Kroenke et la., 2001);
Interest in and ability to participate in and complete the PEARL intervention andprotocol as outlined;
Normal hepatic functioning as determined by prior medical history or/and screeningbloodwork (INR<1.5, Aspartate aminotransferase/Alanine Aminotransferase (AST/ALT) < 2x upper limit of normal, normal range bilirubin, platelets > 150)
Normal renal functioning as determined by prior medical history or/and screeningbloodwork (eGFR>45)
Participants who are sexually active and could become pregnant must be usingeffective birth control (per their physician), prior to study entry, during studyparticipation, and for the duration of the study. Participants who are sexuallyactive and could inseminate a partner must agree to use effective birth controlafter psilocybin administration until the end of study. For participants ofchild-bearing potential, a negative serum pregnancy test result is required atscreening. A urine pregnancy test will be administered on the morning of psilocybinadministration for applicable participants. Participants cannot be pregnant ornursing through the duration of the study;
If using prescribed medications or other substances, participants must agree torefrain from taking them if instructed by study investigators. These include:
not using any non-prescription medication, nutritional supplement, or herbalsupplement except when approved by the treatment team (exceptions will beevaluated by the Investigator and will include acetaminophen, non-steroidalanti-inflammatory drugs, and common doses of vitamins and minerals),
not using nicotine for at least 2 hours before psilocybin administration, andnot again until approximately 7 hours after psilocybin administration,
consuming approximately the same amount of caffeine-containing beverages (e.g.,coffee, tea) that they consume on a usual morning before arriving at thetreatment centre for the psilocybin session day,
not taking any as needed medications on the mornings of psilocybin sessions (with the exception of daily and as needed opioid pain medication),
refraining from using any psychoactive drugs, including alcoholic beverages,within 24 hours of the psilocybin administration.
- Participants must have someone drive them after the session to where they arestaying (home, hotel or another location), because psilocybin may affect theiralertness and concentration on the evening of the dosing session.
Exclusion
Exclusion Criteria:
Cancer of the brain or metastasis to the brain;
Symptoms consistent with delirium, psychosis, or other symptoms judged to beincompatible with establishment of rapport or safe exposure to psilocybin;
A history of past intolerability of psilocybin or other psychedelics;
Past/present psychiatric diagnoses including bipolar disorder, psychotic disorders,active substance use disorders or suicidality (as distinguished from desire forhastened death or readiness for death, per the discretion of the study team);
If participant is under 30 years of age and has first degree relative with a primarypsychotic disorder;
Severe hypertension (defined as systolic blood pressure >140/or diastolic pressure >90) based on two readings on the same day. If the second reading remains over 140/90 patient can be brought in for another reading on a different day. Patientscan be re-screened for participation once blood pressure is adequately controlled;
Known paraneoplastic syndrome or "ectopic" hormone production by the primary tumorif incompatible with psilocybin, determined in consultation with the studypalliative care physician. Patients could be enrolled if it is determined that thepatient's condition is compatible with psilocybin administration.
Cardiovascular conditions including uncontrolled hypertension, angina, a clinicallysignificant ECG abnormality (e.g., atrial fibrillation without rate control),transient ischemic attack in the last six months, stroke, peripheral or pulmonaryvascular disease (no active claudication);
Uncontrolled epilepsy or history of seizures in past 6 months;
Participants with diabetes who are unable to skip a meal (lunch), or whose diabetesrequires administration of medication more than twice daily, or who have hadsymptomatic hypoglycemia within the prior 30 days
GI bleed in last 6 months;
Use of other agents that would be inappropriate to take with psilocybin in thejudgement of the investigator. These agents may include psychoactive prescriptionmedications (e.g., benzodiazepines, lithium, Selective serotonin reuptakeinhibitors), medications having a primary pharmacological effect on serotonin-2a (5-HT2A) receptors (e.g., olanzapine), or medications that are monoamine oxidase (MAO) inhibitors, any potent metabolic inducers (e.g. rifamycin, rifampin,rifabutin, rifapentine, carbamazepine, phenytoin, phenobarbital, nevirapine,efavirenz, taxol, dexamethasone, St John's wort) or inhibitors (e.g. HIV proteaseinhibitors, itraconazole, ketoconazole, erythromycin, clarithromycin,troleandomycin).
Of note, in suitable patients, these medications may be paused or tapered between study enrolment and prior to the start of the intervention when it is deemed safe to do so. A safe and appropriate tapering regimen will then be developed based on the particular medication, on a case-by-case basis. If taking an MAO inhibitor, the psilocybin session will not be conducted until at least 5 half-lives of the agent have elapsed after the last dose. Patients prescribed opioids will be allowed to take their usual dose regimen for analgesia, including the use of as needed analgesic medications on psilocybin session days.
Study Design
Study Description
Connect with a study center
Princess Margaret Cancer Centre
Toronto, Ontario M5G 2M9
CanadaActive - Recruiting
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