Testing Psilocybin for caregiver distress

Inclusion

• +Normal renal functioning as determined by prior medical history or/and screeningScreeningThe checks done before joining, to see whether a study fits.Read more → bloodwork (estimated glomerular filtration rate \[eGFR\]\>45).
• +18 years of age or older.
• +Participant must reside in Ontario, Canada.
• +Ability to speak and read English (participant to provide written informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → 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 enrolledEnrolmentThe number of participants a study plans to include, or has included.Read more → in a companion trial of PEARL for patients with advanced cancer or caregiver of a patient receiving psilocybin-therapy through the Special Access Program (SAP) at University Health Network (UHN); such patients will have been recruited from psychosocial oncology or palliative care clinics at Princess Margaret (study physicians to assess appropriateness of inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and whether treatment will support the family system).
• +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 protocolProtocolThe detailed plan a study must follow.Read more → 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, normal range bilirubin, platelets ≥150).
• +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 SponsorSponsorThe organisation responsible for the study overall.Read more →-InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → and will include acetaminophen, non-steroidal anti-inflammatory drugs, and common doses of vitamins and minerals).
• +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 alertness and concentration on the evening of the dosing session.
• +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 reach them for emergency support in the 24 hours following the psilocybin dosing session. Because the therapists will change from participant to participant, the study team cannot provide the same emergency phone number to every study participant.
• +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, vaginal ring, injectables, and implants); intrauterine device (IUD) or intrauterine system (IUS); vasectomy or tubal ligation). Alternatively, they may use a combination of two or more effective methods of contraception which include male condom, female condom, cervical cap, diaphragm, or contraceptive sponge. These acceptable methods of contraception must be used prior to study entry, during study participation, and for the duration of the 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.
• +not using nicotine for at least 2 hours before psilocybin administration, and not again until approximately 7 hours after psilocybin administration.