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Psychedelic Therapy

Psilocybin Therapy for Cancer

Phase 2

Recruiting

Led By Sarah Hales, MD

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Confirmed diagnosis of stage IV solid tumour cancers, sarcoma, endocrine, melanoma cancers, or stage 4 lymphoma with expected survival of >6 months

Normal renal functioning (eGFR>45)

Must not have

Known paraneoplastic syndrome or 'ectopic' hormone production by the primary tumor incompatible with psilocybin

GI bleed in last 6 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test the effects of a high dose of psilocybin (magic mushrooms) on participants in a therapy setting.

Who is the study for?

This trial is for adults over 18 with stage IV solid tumor cancers, sarcoma, endocrine, melanoma cancers, or stage 4 lymphoma who have a life expectancy of more than 6 months. They must have mild depressive symptoms and be able to use birth control if sexually active. Exclusions include severe hypertension, certain cardiovascular conditions, past intolerances to psychedelics like psilocybin, specific psychiatric diagnoses or substance abuse issues.

What is being tested?

The PEARL Pilot study tests the effects of a single high-dose (25 mg) of psilocybin in combination with Psilocybin-assisted Existential, Attachment and RelationaL (PEARL) therapy on patients with advanced cancer. It aims to explore how this treatment can help manage existential distress associated with their condition.

What are the potential side effects?

Psilocybin may cause psychological effects such as changes in perception, mood swings and potentially anxiety or panic reactions. Physical side effects might include headaches or nausea. The impact varies from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a stage IV cancer diagnosis and am expected to live more than 6 months.

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My kidney function is normal.

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I am older than 18 years.

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I experience mild or more severe symptoms of depression.

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My liver functions are within normal ranges.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer causes hormone imbalances not suitable for psilocybin treatment.

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I have not had a GI bleed in the last 6 months.

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I have a close family member under 30 with a severe mental health condition.

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My cancer has spread to the brain.

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I do not have symptoms like delirium or psychosis that make psilocybin unsafe for me.

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I have not had seizures or uncontrolled epilepsy in the last 6 months.

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I do not have uncontrolled heart conditions or recent strokes.

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I have diabetes that needs frequent medication or had low blood sugar symptoms recently.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability of PEARL therapy from the perspective of advanced cancer patients obtained through qualitative interviews.

Adherence feasibility as assessed by the number of patients completing all PEARL sessions/number of patients consented.

Recruitment feasibility as assessed by the number of patients who consent/number of patients who meet eligibility criteria.

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Secondary study objectives

Patient perspectives on the clinical relevance of potential PEARL therapy outcomes: Anxiety symptoms as assessed with the GAD-7

Patient perspectives on the clinical relevance of potential PEARL therapy outcomes: Broad quality of life construct in patients facing end of life as assessed with the QUAL-EC

Patient perspectives on the clinical relevance of potential PEARL therapy outcomes: Death anxiety in advanced cancer patients as assessed with the DADDS

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