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 range18 Years
SexALL
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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).
✓. 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).
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.
✕. 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).