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New treatment option for Caregiver Distress
Official title Psilocybin-assisted Existential, Attachment and RelationaL (PEARL) Therapy for Caregivers of Patients With Advanced Cancer
ClinicalTrials.gov ID: NCT07048743
What this study is testing
What is Psilocybin?
Psilocybin is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for caregiver distress.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The PEARL-C1 trial 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- 18 years of age or older.
- Participant must reside in Ontario, Canada.
- Ability to speak and read English (participant to provide written informed consent and participate in PEARL intervention, as determined by study...
- No cognitive impairment indicated in medical record or by the primary care physician.
- Primary or significant caregiver of a patient with advanced cancer enrolled in a companion trial of PEARL for patients with advanced cancer or...
You likely can't join if
- A history of past intolerability to psilocybin or other psychedelics.
- Past/present psychiatric diagnoses of bipolar disorder, any psychotic disorder, active substance use disorders, or dementia. a. Participants may have...
- Clinically significant suicidal ideation either currently or within the past 6 months, as judged by study clinicians.
- Participant under the age of 30 years who has a first degree relative with a primary psychotic disorder.
- Other personal circumstances or behaviour judged to be incompatible with establishment of rapport or safe exposure to psilocybin.
- Severe hypertension (defined as systolic blood pressure \>140 or diastolic pressure \>90) based on two readings on the same day. If the second...
See the full eligibility criteria
Who can join
- 18 years of age or older.
- Participant must reside in Ontario, Canada.
- Ability to speak and read English (participant to provide written informed consent and participate in PEARL intervention, as determined by study personnel).
- No cognitive impairment indicated in medical record or by the primary care physician.
- Primary or significant caregiver of a patient with advanced cancer enrolled in a companion trial of PEARL for patients with advanced cancer or caregiver of a patient receiving psilocybin-therapy through the Special...
- At least mild anxiety or depression symptoms, defined as a score of \>5 on the General Anxiety Disorder-7 (GAD-7) or \>8 on the Patient Health Questionnaire-9 (PHQ-9).
- Interest in and ability to participate in and complete the PEARL intervention and protocol as outlined.
- Normal hepatic functioning as determined by prior medical history or/and screening bloodwork (international normalized ratio [INR]\<1.5, aspartate aminotransferase [AST]/alanine transaminase [ALT] \< 2x upper limit of...
- Normal renal functioning as determined by prior medical history or/and screening bloodwork (estimated glomerular filtration rate [eGFR]\>45).
- Participants who are sexually active and could become pregnant or inseminate a partner must be using one method of highly effective contraception (hormonal contraceptives (e.g. combined oral contraceptives, patch...
- 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...
- 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 Sponsor-Investigator and will include...
- 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 consumes 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.
- Participants must have a responsible individual to drive them after the dosing session to where they are staying (home, hotel or another location) and to accompany/attend to them because psilocybin may affect their...
- Participants must agree not to drive or operate machinery for at least 24 hours after dose administration.
- The therapist involved in the participant's psilocybin dosing session and/or the principal investigators will provide their phone number, in advance of the session, to the participant, in case the participant needs to...
What rules you out
- A history of past intolerability to psilocybin or other psychedelics.
- Past/present psychiatric diagnoses of bipolar disorder, any psychotic disorder, active substance use disorders, or dementia. a. Participants may have current mild alcohol or cannabis use disorder (meets 3 of 11...
- Clinically significant suicidal ideation either currently or within the past 6 months, as judged by study clinicians.
- Participant under the age of 30 years who has a first degree relative with a primary psychotic disorder.
- Other personal circumstances or behaviour judged to be incompatible with establishment of rapport or safe exposure to psilocybin.
- 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 the participant can be brought in for another...
- Hepatic dysfunction (history of cirrhosis and/or abnormal parameters [INR\>1.5, elevated AST/ALT 2x upper limit, elevated bilirubin, platelets \< 150]) or liver failure, defined as clinical diagnosis of liver fibrosis...
- Cardiovascular conditions including uncontrolled hypertension, heart failure (defined as class IV of the New York Heart Association classification), angina, a clinically significant electrocardiogram [ECG] abnormality...
- Uncontrolled epilepsy or history of seizures.
- Diabetes with inability to skip a meal (lunch), requiring administration of medication more than twice daily, or symptomatic hypoglycemia within the prior 30 days.
- GI bleed in last 6 months.
- Use of other investigational agents that would be inappropriate to take with psilocybin in the judgement of the investigator, psychoactive prescription medications (e.g., benzodiazepines, lithium, SSRIs), medications...
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.