Trial Title:
Psilocybin-assisted Existential, Attachment and RelationaL (PEARL) Therapy for Patients With Advanced Cancer
NCT ID:
NCT06416085
Condition:
Advanced Cancer
Stage IV Solid Tumor Cancer
Stage IV Sarcoma of Bone
Stage IV Lymphoma
Stage IV Melanoma
Endocrine Cancer
Conditions: Official terms:
Neoplasms
Endocrine Gland Neoplasms
Psilocybin
Conditions: Keywords:
Advanced Cancer
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Psilocybin
Description:
Single high-dose (25mg) capsule of psilocybin taken orally in the context of
Psilocybin-assisted Existential, Attachment and RelationaL (PEARL) therapy
Arm group label:
Psilocybin
Summary:
The PEARL Pilot is a phase II open-label trial. Participants will receive a single
high-dose (25 mg) of psilocybin in the context of Psilocybin-assisted Existential,
Attachment and RelationaL (PEARL) therapy.
Detailed description:
Individuals with advanced cancer often experience high levels of distress due to physical
suffering, difficult treatment decisions, social isolation, and fear of death. While
there are many treatment options for the management of physical symptoms associated with
cancer, there are relatively few standard treatment approaches to help patients deal with
psychological and existential suffering. Over the past decade, research has shown that
psychotherapies incorporating existential, attachment and relational approaches can
address the specific needs and challenges of the advanced cancer population and thus help
to reduce distress. Simultaneously, recent research has shown that psilocybin-assisted
psychotherapy, in which, an individual ingests the psychoactive drug within the carefully
monitored therapeutic setting, can reduce end-of-life distress and greatly benefit those
with advanced disease. The multidisciplinary team has combined these two evidence-based
approaches into what the team calls Psilocybin-assisted Existential, Attachment and
RelationaL (PEARL) therapy. PEARL therapy combines elements from psilocybin-assisted
psychotherapy, including preparatory therapy sessions, a high-dose drug session, and
integration sessions, with important elements from manualized individual psychotherapies
designed for patients with advanced cancer. This study will assess the feasibility,
acceptability, and safety of PEARL therapy among patients with advanced cancer. This
study will yield important information about the feasibility of this type of therapy and
contribute to the growing research around the efficacy of psychedelic-assisted therapies.
This type of therapy has the potential to improve quality of life among those with
advanced disease and careful research is needed to build upon previous findings to
outline the necessary components of therapy and guide public policy, legislation, and
clinical guidelines.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. >18 years of age;
2. Ability to speak and read English (patient to provide written informed consent and
participate in PEARL intervention, as determined by study personnel);
3. No cognitive impairment indicated in medical record or by attending oncologist or
palliative care physician;
4. Confirmed diagnosis of stage IV solid tumour cancers, sarcoma, endocrine, melanoma
cancers, or stage 4 lymphoma with expected survival of greater than 6 months as
determined by their oncologist or palliative care physician;
5. At least mild depressive symptoms, defined as >8 on the Patient Health
Questionnaire-9 (PHQ-9) (Kroenke et la., 2001);
6. Interest in and ability to participate in and complete the PEARL intervention and
protocol as outlined;
7. Normal hepatic functioning as determined by prior medical history or/and screening
bloodwork (INR<1.5, Aspartate aminotransferase/Alanine Aminotransferase (AST/ALT) <
2x upper limit of normal, normal range bilirubin, platelets > 150)
8. Normal renal functioning as determined by prior medical history or/and screening
bloodwork (eGFR>45)
9. Participants who are sexually active and could become pregnant must be using
effective birth control (per their physician), prior to study entry, during study
participation, and for the duration of the study. Participants who are sexually
active and could inseminate a partner must agree to use effective birth control
after psilocybin administration until the end of study. For participants of
child-bearing potential, a negative serum pregnancy test result is required at
screening. A urine pregnancy test will be administered on the morning of psilocybin
administration for applicable participants. Participants cannot be pregnant or
nursing through the duration of the study;
10. If using prescribed medications or other substances, participants must agree to
refrain from taking them if instructed by study investigators. These include:
- not using any non-prescription medication, nutritional supplement, or herbal
supplement except when approved by the treatment team (exceptions will be
evaluated by the Investigator and will include acetaminophen, non-steroidal
anti-inflammatory drugs, and common doses of vitamins and minerals),
- not using nicotine for at least 2 hours before psilocybin administration, and
not 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 the
treatment 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.
11. Participants must have someone drive them after the session to where they are
staying (home, hotel or another location), because psilocybin may affect their
alertness and concentration on the evening of the dosing session.
Exclusion Criteria:
1. Cancer of the brain or metastasis to the brain;
2. Symptoms consistent with delirium, psychosis, or other symptoms judged to be
incompatible with establishment of rapport or safe exposure to psilocybin;
3. A history of past intolerability of psilocybin or other psychedelics;
4. Past/present psychiatric diagnoses including bipolar disorder, psychotic disorders,
active substance use disorders or suicidality (as distinguished from desire for
hastened death or readiness for death, per the discretion of the study team);
5. If participant is under 30 years of age and has first degree relative with a primary
psychotic disorder;
6. 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. Patients
can be re-screened for participation once blood pressure is adequately controlled;
7. Known paraneoplastic syndrome or "ectopic" hormone production by the primary tumor
if incompatible with psilocybin, determined in consultation with the study
palliative care physician. Patients could be enrolled if it is determined that the
patient's condition is compatible with psilocybin administration.
8. Cardiovascular conditions including uncontrolled hypertension, angina, a clinically
significant ECG abnormality (e.g., atrial fibrillation without rate control),
transient ischemic attack in the last six months, stroke, peripheral or pulmonary
vascular disease (no active claudication);
9. Uncontrolled epilepsy or history of seizures in past 6 months;
10. Participants with diabetes who are unable to skip a meal (lunch), or whose diabetes
requires administration of medication more than twice daily, or who have had
symptomatic hypoglycemia within the prior 30 days
11. GI bleed in last 6 months;
12. Use of other agents that would be inappropriate to take with psilocybin in the
judgement of the investigator. These agents may include psychoactive prescription
medications (e.g., benzodiazepines, lithium, Selective serotonin reuptake
inhibitors), 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 protease
inhibitors, 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Princess Margaret Cancer Centre
Address:
City:
Toronto
Zip:
M5G 2M9
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Sarah Hales, MD
Investigator:
Last name:
Sarah Hales, MD
Email:
Principal Investigator
Investigator:
Last name:
Emma Hapke, MD
Email:
Principal Investigator
Investigator:
Last name:
Daniel Rosenbaum, MD
Email:
Principal Investigator
Start date:
June 6, 2024
Completion date:
June 15, 2026
Lead sponsor:
Agency:
University Health Network, Toronto
Agency class:
Other
Source:
University Health Network, Toronto
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06416085
