Phase II randomized controlled trial, followed by an open-label extension phase. In the main study, participants will receive either a single high-dose (25 mg) or low-dose (1 mg) of psilocybin in the context of Psilocybin-assisted Existential, Attachment and RelationaL (PEARL) therapy. Upon completion of main study, participants who received the low dose will be offered to receive a single high-dose of psilocybin (25 mg) in the context of PEARL therapy (Open label extension study).
>/= 18 years of age
Ability to speak and read English fluently (participant 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;
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);
Parallel
Psilocybin (25mg)
DrugSingle high-dose (25mg) capsule of psilocybin taken orally in the context of Psilocybin-assisted Existential, Attachment and RelationaL (PEARL) therapy
Psilocybin (1mg)
DrugSingle low-dose (1mg) capsule of psilocybin taken orally in the context of Psilocybin-assisted Existential, Attachment and RelationaL (PEARL) therapy
PEARL Therapy
Other interventionPsilocybin-assisted Existential, Attachment and RelationaL (PEARL) therapy
Change in mean severity of depressive symptoms as assessed by the Montgomery-Asperg Depression Rating Scale (MADRS) score from baseline to 2 weeks after completion of PEARL therapy, comparing the 25mg psilocybin group with the 1mg psilocybin group.
The MADRS is a 10-item rater-administered scale measuring depressive symptoms. Total score range is 0 to 60, with higher scores indicating greater severity of depressive symptoms.
Number of participants with treatment-related adverse events after PEARL as assessed by the Swiss Psychedelic Side Effects Inventory (SPSI).
The SPSI is a 32-item self-report measure designed to systematically assess adverse effects experienced by participants in studies involving psychedelic drugs and MDMA. The inventory contains 32 clinically relevant side effects and assesses severity, impact, duration, treatment-relatedness and timing.
Change in mean anxiety symptoms from baseline to T3 as assessed by the Generalized Anxiety Disorder (GAD-7) scale.
The GAD-7 is a 7-item self-report scale used to screen for and measure anxiety symptoms. Total score range is 0 to 21. Higher scores indicate higher levels of anxiety.
Change in death-related distress from baseline to T3 as assessed by the Death and Dying Distress Scale (DADDS).
The DADDS is a 15-item self-report measure designed for populations facing imminent death and addresses fears about the dying process, and about lost opportunities and self-perceived burden placed on others as a result of impending mortality. Total score range is 0 to 75. Higher scores indicate greater death-related distress.
Change in demoralization symptoms from baseline to T3 as assessed by the Demoralization Scale (DS).
The DS is a 24-item self-report measure that assesses loss of meaning and purpose, disheartenment, and helplessness. Total score range is 0 to 96. Higher scores indicate higher levels of demoralization.
Quality of Acute Drug Experience in response to PEARL as assessed with Mystical Experiences Questionnaire (MEQ30) and the Persisting Effects Questionnaire (PEQ).
Quality of Acute Drug Experience will be measured with the Mystical Experiences Questionnaire (MEQ30). Any persisting effects of the drug will be assessed using the following three questions from the Persisting Effects Questionnaire (PEQ): 1) how personally meaningful was the experience; 2) how spiritually significant was the experience; and 3) did the experience change your sense of well-being or life satisfaction?
Assess the nature of the PEARL therapy experience and what factors are associated with positive or negative outcomes via qualitative study of participants
All participants from both study arms will be invited to take part in a semi-structured interview to explore the PEARL experience and factors that influenced it (i.e., aspects of identity including gender, race, ethnicity, the gender(s) of therapist dyads and perceived psilocybin dose). Throughout the study, the guide will be modified to focus attention on areas of particular importance to the emerging qualitative interpretations.
Integrity of masking of PEARL.
Integrity of Trial Masking will be assessed the day after the psilocybin dosing session by asking both participants and study therapists to guess treatment condition assignment.
Assess the predictors of response to PEARL as assessed by demographics, cancer type, medical and psychiatric comorbidities and depression diagnosis.
As measured by: * demographic information (self-report including age, sex, gender, race, ethnicity, sexual orientation, level of education, marital status, household income, and housing status) * Medical and Background Information (cancer type and stage, length of illness, previous psychiatric and medical diagnoses, current medications, and past use of psychedelic medicines) * The Structured Clinical Interview for DSM-5 Disorders Research Version (SCID-5-RV)
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
