Psilocybin-assisted Existential, Attachment and RelationaL (PEARL) Therapy for Patients With Adva… (NCT06416085) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Psilocybin-assisted Existential, Attachment and RelationaL (PEARL) Therapy for Patients With Advanced Cancer
Canada15 participantsStarted 2024-06-06
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. \>18 years of age.
. Ability to speak and read English (patient to provide written informed consent and participate in PEARL intervention, as determined by study personnel).
. Resident of Ontario.
. No cognitive impairment indicated in medical record or by attending oncologist or palliative care physician.
. 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.
. At least mild depressive symptoms, defined as \>8 on the Patient Health Questionnaire-9 (PHQ-9) (Kroenke et la., 2001).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Recruitment feasibility as assessed by the number of patients who consent/number of patients who meet eligibility criteria.
Timeframe: 24 months
2
Retention feasibility as assessed by the number of patients completing primary endpoint measures/number of patients consented.
Timeframe: 24 months
3
Adherence feasibility as assessed by the number of patients completing all PEARL sessions/number of patients consented.
Timeframe: 24 months
4
Acceptability of PEARL therapy from the perspective of advanced cancer patients obtained through qualitative interviews.
. Interest in and ability to participate in and complete the PEARL intervention and protocol as outlined.
. 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.
Exclusion criteria
. Primary cancer of the brain, or metastasis to the brain associated with clinically significant symptoms (e.g., affective, cognitive, personality-related, psychotic, or other symptoms, including seizures).
. Symptoms consistent with delirium, psychosis, or other symptoms judged to be incompatible 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 I 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).
. If participant is under 30 years of age and has first degree relative with a primary psychotic disorder.
. Severe hypertension (defined as systolic blood pressure \>150/or diastolic pressure \>95) based on two readings on the same day. If the second reading remains over 150/95, the 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.
. Moderate or severe hepatic impairment, as defined by Child-Pugh class B or C, or elevations in AST or ALT greater than 3 times the upper limit of normal.
. Severe renal impairment (defined as eGFR \< 30).