top of page

Information for Clinical Trial Participants

This site is for demonstration purposes only and does not represent a Informed Consent for which has been approved by the Research Ethics Board

Participant Information and Consent Form

 

 

Study Title: An Open-Label, Unblinded, Pragmatic Feasibility Study Using Psilocybin-Assisted Therapy (PaT) in a Community of Practice (CoP) Program for End-of-Life Patients

Qualified Investigator:          

Dr. Valorie Masuda, MD, CCFP(PC), Department of Palliative and End-of-Life Care

Vancouver IslandHealth Authority

71 Government St. Duncan, BC. V9L 1M4

 

Sponsor:                                

Vancouver Island Health Authority

1952 Bay Street

Memorial Pavilion, Kenning Wing 1st Floor.

Victoria, BC. V8R 1J8

 

In Case of Emergency:

For urgent care, call 911 or visit Cowichan District Hospital Emergency Department.

3045 Gibbins Rd, Duncan, BC V9L 1E5, or your nearest emergency department.

 

Non-emergency Contact Number:

For health care issues, please contact your primary care provider or

Contact Health Link BC at 8-1-1 for 24-hour access to non-emergency health information.

For issues resulting directly from the study treatment, contact the Qualified Investigator at (250)710-3697

Description of Terms

 

Adverse Event: Any unpleasant, unexpected, or inconvenient medical or psychological occurrence in a study participant, before the administration of the study medication which is not necessarily related to the study treatment itself. Adverse events that occur after the study treatment is administered that are suspected of or determined to be directly related to the study treatment itself are called “treatment-emergent adverse events”.

 

Altered State of Consciousness: Any temporary change in one’s state of mind that is different from one’s typical waking, day-to-day patterns of thinking and perceiving oneself and one’s surroundings. Also called an “altered state of awareness”, this state can happen naturally through activities such as deep concentration, meditation, prayer, breathing exercises, extreme physical discomfort or pleasure, or during some states of sleep. An altered state of consciousness or awareness can also be caused by mind-altering compounds and substances such as psilocybin.

 

Compassionate Listening: To listen to another and to reflect back the emotions and body sensations that have arisen in you by listening to another.  

 

Community of Practice (CoP): A group therapy model in which participants are supported by facilitators and each other for the preparation of the psilocybin as well as the re-training the brain and body (integration).  This creates new relationships with one’s thoughts, emotions, body and terminal illness within the context of being seen and heard as an authentic person within a safe community. 

 

De-identified Data: Means ensuring your name or any other identifying information you may have provided, is not associated with your responses to questionnaires, or any other data collected about you during the study. This occurs, as discussed above, via the unique study ID number you will be assigned at the beginning of this study. The only time someone other than the Study Coordinator may know which participant has which study ID number is if there is a safety event which the Medical Monitor and Qualified Investigator must be made aware of. Any data published from this study will always remain anonymous.

 

End-of-Life Distress (EoLD):  Persistent thoughts of hopelessness, worthlessness, purposelessness, grief, fear pertaining to a diagnosis of terminal illness, death and dying. 

 

Feasibility Study: Aims to objectively and rationally uncover the strengths and weaknesses of an existing project. It is an assessment of the practicality of a project or system.  It asks the questions, “Can this study be done in this way?”.

 

Informed Consent:  A mandatory ethical process for potential research study participants that helps ensure they are provided with as much information as possible prior to study participation so they can make the best decision for themselves about participating. The information provided to the participant thoroughly discusses the research study design and goals, who will providing them care, alternative therapy options to the research project, participant rights of confidentiality and personal information protection, decision-making rights, participant responsibilities, research team responsibilities, what they can expect from the treatment in terms of potential advantages and disadvantages, and the potential positive or negative impacts of the research treatment on their health and wellbeing

 

Integration: The word integration takes its roots from the Latin word 'integratio’, which means to 'make whole', 'renew', or 'to begin again'. It is a process of considering the knowledge, wisdom, and insights that may arise during a psilocybin treatment session and exploring how these may be incorporated into day-to-day life in an ongoing wayIntegration will be an ongoing part of the Community of Practice curriculum. These concepts will be incorporated into every group session with opportunities for group members to explore and share about their own experiences and ongoing learnings from their psilocybin journey and the impact on their perspectives, habits, emotional experience, and relationships.

 

OWL: A secure, password-protected and comprehensive Electronic Medical Record (EMR) system that confidentially stores patient information and clinician assessments and notes. It is Personal Health Information Protection Act (PHIPA) regulation compliant with the BC College of Physicians and Surgeons.  It has bank-level encryption that moves data on dedicated Canadian servers Only a few Treatment Team members will have access to this information. It is hosted by the SATA Centre for Conscious Living

 

Pragmatic: An approach to solving problems in a sensible way that suits the conditions that really exist now, rather than obeying fixed theories, ideas, or rules.

 

Psilocybin: A psychedelic medicine extracted from the psilocybe cubensis mushroom.

 

Psilocybin-Assisted Therapy (PaT): Use of psilocybin in a program of therapy which allows a period of time for the brain to move out of set thoughts and behaviour patterns and allows for an opportunity to replace the previous thoughts and behaviours aligning with health and wellness. 

 

Psychedelic: Refers to substances that can create a mental state characterized by a profound sense of intensified sensory change including in one’s perception of reality, time, and of oneself.  (See the above description of “altered state of consciousness”). Experiences brought on by a psychedelic substance can also include significant changes in one’s vision, hearing, smell, taste and sense of touch as well as other body sensations such as trembling, nausea, increased pressure, or even pain. These temporary changes are also called “perceptual distortions” or “hallucinations” and may be accompanied by extreme feelings of joy, gratitude, awe, and wonder or by feelings of fear, sadness, confusion, or despair. Sometimes psychedelics are described as being capable of expanding consciousness or conscious awareness.

 

REDCap: A secure and protected Electronic Data Capture platform where research data is entered, confidentially stored, and processed. REDCap is hosted behind BC Children’s Hospital security systems and firewall. Only a few Study Team members have access to these records which remain anonymous to the researchers by using a unique study identification (ID) number that you are randomly assigned at the beginning of the study. Only the Study Coordinator will know which unique study ID belongs to which individual study participant.

 

Set and Setting: Terms used in the field of psychedelic research and therapy to describe the psychological and environmental factors that combine to support or interfere with the quality of a psychedelic experience. “Set” refers to one’s mindset, hopes, expectations, understanding and personality traits and “setting” refers to the combination of social, environmental, and cultural factors that surround the psychedelic session.

 

Side Effect: Any physical or psychological occurrence, positive or negative/pleasant or unpleasant/desirable or undesirable/mild, serious, or life-threatening, that one experiences during or after receiving a treatment, procedure, or medication/drug/substance.

 

Study Team:  The Study Team is comprised of the individuals responsible for the research details which also includes a nurse and doctors as well as professionals involved in research data analysis (see page 4 of this document). These individuals are different people from those on the Treatment Team and our roles interacting with you during the study are purposefully kept separate for the integrity of the research. The only time we will directly communicate with each other about your medical information is if there are safety concerns that arise during the course of the study.

 

Terminal Illness:  An illness which is life-limiting, that is, it is incurable and will result in death. 

 

Treatment Team: The Research Team is divided into two groups (see page 4 of this document). The Treatment Team are the nurses, doctors, and therapists you will be interacting with on a regular basis over the course of your study participation.

 

Unblinded: A term used in research to describe a study design in which the participants and/or research team members know what treatment is being given to study participants (I.e., there is no alternate, inactive substance (or ‘placebo’) in the study. All participants in this study will receive the psilocybin treatment unless something stops this from being possible immediately prior to treatment (discussed later in this document).

 

Introduction

Your doctor believes you may be an appropriate candidate for this research study. It is important that you know why the study is being done, what it will involve, and have the opportunity to ask any questions before you decide to participate.  This document is designed to provide you with all of the information about the research study so you can make a fully informed decision about participating. If you decide you would like to participate, we invite you to email us at:   valorie.masuda@islandhealth.ca  in order to set up a screening session to further assess whether this study is a good fit for you.

Research and our own patient experience to date indicates that along with care and sensitivity, patients desire clarity and directness from health care providers when discussing their health and wellness. Patients have expressed this includes the use of plain language for terms others may feel uncomfortable with.  We realize that some participants may feel uncomfortable or triggered by some of the terms used in study related documents like this one as well as within the large and small group sessions that are part of this study’s research design. 

We want you to know this ahead of time, so you have a chance to consider and express what feels right for you. Terms that may cause discomfort for some participants can include words and phrases such as death, dying, end-of-life, terminal illness, anxiety, panic, depression, paranoia, existential distress, suffering etc.  We will utilize these words during our large and small group session in a safe and secure environment with trained professionals. Should you choose to participate in this study, we invite you to share with us how we can improve the language we use to enhance your sense of comfort.

Your participation is voluntary

Your participation in this study is entirely voluntary, which means it is your choice and your choice alone.  If you decide to participate, you may still choose to withdraw from the study at any time without any negative consequences to the medical care, education, or other services to which you are entitled or are presently receiving.

You should be aware that there is a difference for both you and your doctor between being a patient and being a research participant. As a patient, all medical procedures and treatments are carried out for your benefit only according to standard accepted practice. As a research participant, you and your doctor must also consider the requirements for the research study. These may include procedures and treatments that are not part of standard practice or are not yet proven. This consent form describes the treatment procedure that is being carried out for research purposes. Please review the consent document carefully when deciding whether you wish to be part of the research. 

Please take time to read the following information carefully and to discuss it with your family, friends, and doctor(s) before you make your decision.

Who is conducting this study?

This study is being conducted by the Vancouver Island Health Authority in collaboration with the SATA Centre for Conscious Living[.

  

Study Team Members

 

Qualified Investigator:  Dr. Valorie Masuda, MD, Palliative Care and Emergency Physician, Vancouver Island Health Authority, SATA Centre for Conscious Living.

Study Coordinator:  Nicole Klementis, Registered Nurse. SATA Centre for Conscious Living.

Medical Monitor: Dr. Kim Adzich, MD. Vancouver Island Health Authority.

 

Treatment Team Members: 

 

Study Physicians: 

Dr. Laura McLean, MD, FRCPC, dipABLM. Internal Medicine Specialist, Respirologist.

Dr. Edward Brooks, MD. Oncologist, BC Cancer Agency.

Dr. Christien Weins, MD. Psychiatrist Cancer Agency and Vancouver Island Health Authority.

Dr. Fraser Black, MD. Palliative Care Physician, Vancouver Island Health Authority.

 

Study Nurses: 

Andrea Lemp, Registered Nurse, SATA Centre for Conscious Living.

Gail Peekeekoot, Registered Nurse, SATA Centre for Conscious Living.

 

Study Therapists: 

Sarah Corrin, Registered Clinical Counselor.  SATA Centre for Conscious Living.

K. Louise Vincent, Registered Clinical Counselor,  SATA Counselor, SATA Centre for Conscious Living.

Peter Ceceri, Registered Clinical Counselor. SATA Centre for Conscious Living.

 

Study Pharmacist:

Jagpaul Kaur Deol, BSc (Pharm), RPh. Study Pharmacist. University of British Columbia.

 

Research Team Qualifications:   All study and treatment team members are licensed in good standing with their respective professional licensing and regulatory bodies (i.e., the College of Physicians and Surgeons of BC, the BC College of Nurses and Midwives, BC Association of Clinical Counsellors) and have received training in Good Clinical Practices (GCP) and research ethics involving human subjects. They also have had experience and training in psychedelic-assisted therapy.

 

Background The standard or usual treatment offered for end-of-life distress that may arise with a life-limiting illness is therapy or medication. Unfortunately, many of the available treatments for end-of-life distress do not work for everyone or have unwanted side effects. This has led researchers to study new treatments for end-of-life distress. Psilocybin is a drug being studied as a treatment for many different mental health conditions, like depression and anxiety. Psilocybin is one of the active ingredients in mushrooms of the psilocybe family (or ‘magic mushrooms’) that can create changes in one’s perception and emotions and may have positive benefits for some people who take it. The psilocybin used in this study is a laboratory extracted form derived from the naturally occurring psilocybin which can be found in over 200 species of mushrooms around the world. For many years, different Indigenous communities around the world have used mushrooms that contain psilocybin as part of their ceremonies. Psilocybin is referred to as a ‘classic psychedelic’. It is a hallucinogenic substance, meaning it can create a perception of things that may not be present. Psilocybin belongs to the tryptamine family (like LSD) and is a substance showing promise through research as a treatment for many mental health conditions such as depression and anxiety. While it does have a history of significant recreational use, psilocybin is currently considered an experimental substance in the medical context which has now been used legally in numerous clinical trials to treat individuals with several mental health conditions including anxiety, depression, and end-of-life distress. Psilocybin is currently a ‘controlled substance’ in Canada, which means it has not been approved for medical use, is illegal to possess or distribute, and can only be used for research or clinical purposes that are approved by Health Canada, such as this research study. Studies using psilocybin for emotional distress due to a terminal cancer diagnosis has been studied at John Hopkins University since 1999. In 2016, Dr. Roland Griffiths did a study demonstrating that 86% of participants had increased well-being or life satisfaction, these effects lasting in 82% of participants at 6 month follow up. Other studies since that time have similar results (Agin-Liebes et al.,2020, Griffiths, 2016; Griffiths et 2018, Rosset al., 2016)

What is the purpose of this study?   

The purpose of this study is to evaluate whether using a Community of Practice model is safe and well tolerated method for administering psilocybin to people with end-of-life distress.  This study also is being done to understand if psilocybin-assisted therapy has any impact on your symptoms of end-of-life distress. 

A Community of Practice is a group therapy model in which participants are supported by facilitators and by each other. The Community of Practice group therapy sessions in this study will provide support to you both before and after the psilocybin session. This is called preparation and integration. The intention of a Community of Practice is that it supports people to create a new relationship with their thoughts, emotions, body, and terminal illness, while being seen and heard within a safe community of others experiencing similar challenges.

End-of-life distress can be thought of as persistent thoughts of hopelessness, worthlessness, purposelessness, grief, or fear around a person’s diagnosis of life-limiting terminal illness.

As described above, this study is a “feasibility study” which will test the group therapy model of psilocybin-assisted therapy. This type of study involves a small number of participants (a total number of 64) and is not being conducted to prove safety or effectiveness of the psilocybin itself, though we will be constantly monitoring for safety to protect your health and wellbeing.

The results may be used as a guide for larger studies, although there is no guarantee that they will be conducted. Participation in a feasibility study does not mean that you necessarily will be eligible to participate in a future larger study. Knowledge gained from feasibility studies may be used to develop future, larger studies that may benefit others.

Who can participate in this study?

You may be able to participate in this study if:

  • You have been diagnosed with a terminal illness and given a life-limiting diagnosis

  • You are between 19 – 80 years of age;

  • You are able to provide consent;

  • You are not pregnant or breastfeeding;

  • If you are able to have children and are sexually active, agree to use adequate birth control for the duration of the study and are willing to have a pregnancy test prior to the medicine administration;

  • Agree to be available for the duration of the study and are able and willing to comply with study procedures including completing questionnaires;

  • Have access to a cell phone/tablet/computer, stable internet connection and ability to accept and respond to emails and use a virtual meetings platform.

  • Able to participate in group therapy held in the English language.

Who should not participate in this study?

You will not be eligible to participate in this study if:

  • You are too weak to walk around (mobilize) independently;

  • Are currently pregnant, planning to become pregnant, or are breastfeeding;

  • You are currently taking any medications which would make it unsafe for you to participate in the study;

  • Have a current or previous diagnosis of a psychosis-related disorder, bipolar disorder, or any other psychiatric conditions which may make it unsafe to ingest psilocybin;

  • Have a first degree relative diagnosed with any of the above psychiatric disorders;

  • Have a history of significant uncontrolled cardiovascular disease;

  • Have uncontrolled high blood pressure;

  • Have kidney or liver failure

  • Present a current risk to yourself or others

  • Are not fluent in English.

  • An intake physician or nurse feels that Community of Practice sessions are not appropriate for you

  • You are unable to participate in the Community of Practice sessions (regular scheduling conflicts, lack of access to reliable internet connection etc.)

What does this study involve?

 

Before you begin the study

If you agree to participate in this study, you will be asked to sign this consent form before any study process or procedures will take place.  We ask that you do not sign the consent form until your ‘Consenting Visit’ with a study team member who can guide you through the process fully and clarify any questions or concerns.

Screening Visits Screening visits will take place over the phone or virtually by videoconferencing. To ensure it is medically safe for you to participate in the study, the study doctor will need to review your medical records. This will require you signing a consent form to allow the study team to review medical records from previous hospitalizations, recent bloodwork as well as your current chemotherapy protocols and current medications. Because psilocybin can interact with certain medications and substances which may increase the risk of unwanted side effects, your medication and substance use history will be thoroughly evaluated by a pharmacist to ensure it is safe for you to take the psilocybin. At screening visits, you will also be asked about your mental health and wellbeing. Your mental health and wellbeing will also be monitored throughout the study, including asking about any symptoms of depression and anxiety. There will be 1 or more screening visits. The length of the screening period will depend on how quickly the study team can access your medical records for review.

Community of Practice (CoP) Group Therapy Sessions The Community of Practice (CoP) is the name given to group therapy sessions which occur virtually once a week for 8 sessions over a total of 10 weeks. Each CoP meeting will be two hours long and will take place online (over Zoom videoconferencing). It is required that you have a reliable internet connection and a laptop, tablet, computer or phone. You must also attend more than 80% of these group sessions and cannot miss more than 1 session prior to the psilocybin session (more on this below). Research has shown that when people are going through difficult circumstances, connecting with others that are also going through something similar, can provide a sense of comfort and increase one’s sense strength and capability in the face of those difficulties. This has been shown in the research extensively with those facing terminal or life-limiting illnesses. Each Community of Practice cohort consists of a small group which will have a maximum of 8 participants. Each small group will have 2 facilitators present each week. These facilitators are trained nurses and therapists and will always the same people over the 10-week study. The Community of Practice group therapy sessions in this study are intended to provide emotional and psychological support to you both before and after the psilocybin session through education and relationship with your facilitators and other group members. This is also sometimes referred to as ‘preparation’ (before the psilocybin session) and ‘integration’ (following the psilocybin session). Each week, the Community of Practice will begin by having the 1-2 small groups meet together for a time as a larger group (up to 16 participants) before splitting off into the smaller, more intimate groups. This large group potion of the session is meant to provide inspiration to all study participants at the same time (i.e., through readings and poems) as well as an offering of non-religious exploration of spirituality, mindfulness skills, and meditations. You will be taught various methods of noticing and managing stress and the challenging thoughts you may have at times, helping you move into deeper connection with your emotions, your breath, and your body and to build greater resilience in the face of difficulty. Each week will have a different content focus and include a ‘prompt’ (a thought-provoking question) regarding that week’s focus that you will be invited to consider ahead of time. Breaking into the smaller groups afterwards, allows for more intimate interpersonal connection and a time to share amongst one another about that week’s content and prompt or anything that you may be struggling with or celebrating that you feel like sharing with others in your small group. Engagement in the group will be centered around authentic self-expression and providing compassionate listening for others when they share. You will learn about how to engage in this way from your facilitators at the start of the Community of Practice sessions. It is important to know that while connecting with others in this way is encouraged and supported, you will never be required to share about yourself in ways that you do not want to.

Psilocybin-Assisted Therapy Session The day before your psilocybin-assisted therapy session, which occurs halfway through the 10-week program, you will be required to visit the health centre where the psilocybin administration will take place. This will give you the opportunity to see the space and meet with the study team members and other participants who will be present during your psilocybin-assisted therapy session. In order to determine if it is appropriate for you to take psilocybin, you will have a physical examination by a study doctor. This will involve a review of your current physical and medical status. You will also have an assessment of your mental and emotional status by a study nurse. This will involve a general conversation about how you are feeling in your life and on that day. If you are able to become pregnant, a urine pregnancy test will be performed at this visit. If the study team believe it is unsafe for you to take psilocybin, or if you decide you no longer wish to take psilocybin, then you will not have a psilocybin-assisted therapy session, however, you are welcome to continue with the Community of Practice group sessions for the remainder of the 10-week program. On the day of the psilocybin-assisted therapy session, one of the study physicians will give you a 25 mg capsule of Health Canada-approved psilocybin. Once psilocybin is taken, the immediate effects of the medication will last between four and eight hours. Potential prolonged effects are described below under harms and discomforts. You will have a recliner chair to sit in, a blanket to cover you, eyeshades to use, and instrumental music will be played in the room and on headphones. Unlike other forms of therapy, psilocybin-assisted therapy is largely an inner journey. You will likely not be talking during your experience. But if you need anything, a doctor, a nurse, and a therapist will be present and available to provide you with support at any time with additional medical staff available if needed. A psilocybin experience can bring up powerful emotions that may include fear, panic, confusion, or extreme joy, awe, and gratitude. Some participants may feel the desire for physical acknowledgement or support from other people in the treatment space during these emotional moments. Research participants have described reassuring touch like handholding as helpful when experiencing distress but interpretation of touch or one’s ability to clearly express their needs and desires can also become complicated due to the mind-altering nature of psilocybin (Calder & Hasler, 2023). Prior to the ingestion of the psilocybin, you will be asked if treatment team members may physically touch you in a reassuring (supportive), limited way (non-intimate and only to hands, shoulder, and feet) during the psilocybin session. There will NEVER be hugging, full-body contact or the touching of a sexual nature. The type of limited, reassuring touch you receive is totally under your control and based on your expressed preferences which will be formally captured in a separate consent form entitled: Participant Information and Consent Form for Limited Touch. You may not want any supportive, reassuring touch while you are under the influence of the psilocybin, in an altered state of consciousness and the treatment team supports you in this decision. It will not affect your ability to receive treatment. If his is what you choose, then the therapy team will NOT touch you in any way that you have not consented to once you are in an altered state of consciousness and unable to give informed consent. The other form of physical touch that may be required during the psilocybin session is touch meant to maintain your safety. This may include providing you with medication or medical assistance in the case of an adverse event or medical emergency, helping prevent you from falling if you need to use the washroom, assisting you into a more comfortable position if your experience becomes very physically active, or to help keep you in the treatment facility if you feel like you want to leave. This will also be discussed more fully in the Consent to Touch document you will review with the research team prior to your psilocybin session. Once the effects of the psilocybin have mostly worn off, and if you feel comfortable, there will be an opportunity to share about your experience with the treatment team and fellow Community of Practice group members. There will be further opportunity for sharing and processing of your experience in the ongoing weekly CoP sessions. As part of investigating to potential benefits of this treatment for end-of-life distress, you will be invited to compete a series of short questionnaires before and after the study treatment is completed. These questionnaires will ask you about your mental health and wellbeing during the course of the study, including asking about your depression and anxiety symptoms and the quality of your experiences with psilocybin. We encourage you complete the questionnaires to the best of your ability. Research staff will be available to provide assistance should you require it. You are not required to answer questions you do not feel comfortable answering.

Follow-Up In between study visits, study team members will call you each week to check-in. They will ask you about how you are feeling and any medications you are taking. We will also be calling you to check-in one month after the treatment has ended. If we are unable to connect with you, we will connect with a support person whose name and contact you provide to us, or to your referring physician, for more information on how you are doing. If we have specific concerns at any time, we will consult our physicians or mental health team and determine the best course of action, based on everyone’s unique situation. You will also complete a questionnaire which asks about your experiences within the Community of Practice and during and after the psilocybin session. This is called a qualitative questionnaire. As with all other questionnaires completed in this study, to protect your confidentiality, all qualitative responses will also be be ‘de-identified' as outlined on page 3 of this document. The screening period before the study can last up to four weeks. The study visit period including the CoP group session will last ten weeks. After the study treatment period ends, the follow-up period lasts one month. This means the total time you will be participating in the study for will be up to 18 weeks. In 6 to 12 months after this study has been completed, we may do a follow-up study looking at the long-term effects of the psilocybin therapy program. You may be invited to participate in this long-term follow-up study in which you will complete a follow-up questionnaire. Your participation in this long-term follow up study is optional.

Your responsibilities as a participant If you agree to participate in this study, your responsibilities as a study participant include: •Agreeing to a medical release of information, so the study team physician may access your medical records for review during screening; •Providing a personal contact number that the study team can reach you at for the duration of the study; •Providing the contact information of two people who the research team may contact if they are unable to contact you and if they have concerns about your safety and welfare; •Agreeing to complete study questionnaires to the best of your ability; •Attending all study visits, including participating in the weekly Community of Practice group sessions, as scheduled; •Agreeing to have only a small, light meal 4 hours prior to psilocybin-assisted therapy session to allow for best absorption of the psilocybin; •Agreeing to remain at the study clinic for 6-8 hours or longer on the psilocybin-assisted therapy session day, until the psychoactive effects (feelings of being mentally altered or intoxicated) have worn off and the study team believe it is safe for you to leave; •Agreeing that if you try to leave the premises while you are under the influence of the psilocybin, study staff may take steps to ensure your safety. This may include moving you to a separate space with a therapist, nurse, or doctor or administering additional medications to help calm you. •The after-effects of psilocybin may include temporarily experiencing a lack of mental clarity which may persist for a time following treatment. As such, you agree to have someone drive you home from the psilocybin session, and not to operate any heavy machinery or engage in any driving or other hazardous activity until the morning following the psilocybin treatment.

Your responsibilities as a participant in the Community of Practice (CoP) All participants are required to keep one and another’s experiences and sharing confidential within the group and to protect group agreements for creating and maintaining a safe and supportive environment. These group agreements will be reviewed in the first CoP session to ensure the agreements are something all group members are comfortable with and agree to. Your input is welcome and encouraged in co-creating these agreements. However, if a group member shares privately with you a concern for their health or wellbeing that may involve a desire to harm themselves or someone else, this must be reported to a facilitator right away. This will be reviewed as part of the group agreement process in the first CoP session.

What are the possible harms and discomforts? Potential Adverse Effects of Psilocybin Unlike many medications, substances, or supplements you may have taken in the past or are currently taking, psilocybin is a “psychoactive” substance which means it commonly causes some form of physical, emotional, and/or psychological effects. Psilocybin is considered to be generally well tolerated and has very few long-term adverse effects, moderate short term side effects, and no addictive potential (Johnson et al., 2018; Leonard, Anderson & Klein-Schwartz, 2018; Yerubandi et al., 2024). 67.6% of psilocybin exposures result in 2 or fewer related effects (Leonard, Anderson & Klein-Schwartz, 2018). As with any medicine, it is important to understand the full scope of potential risks and benefits and the range of side effects associated with psilocybin. It is also important to know that these effects on the body are still being studied, and we do not know all the short or long-term effects or risks associated with its use. The following sections break down the potential adverse effects of psilocybin into intermediate, short-term and long-term effects.

Immediate Effects of Psilocybin Most research studies involving psilocybin use a standard high dose of 25 mg of psilocybin to achieve beneficial effects which is what you will be given in this study. At this dose, we expect you to have alterations in your body sensations (including possible nausea) and changes in your thoughts and emotions. Studies, such as those at Johns Hopkins, have shown that these changes may provide some of the benefits associated with taking psilocybin (Agin-Liebes et al., 2020; Griffiths et al., 2016; Griffiths et al., 2018). Alteration in your awareness and experience may also include abnormal perception in all senses such as visual changes, visual hallucinations, changes to hearing and auditory hallucinations, abnormal smells or bodily sensations, and an unusual mixing of sensations where, for example, sounds may be perceived as pictures or images, or colors could be perceived as tastes. These experiences are often accompanied by intense changes in mood states which can include extreme happiness (euphoria) and feelings of love and appreciation or feelings of sadness, anxiety, and even fear. Feelings and emotions can change quickly from one to another through the medicine session and gradually fade as the psilocybin wears off. While these experiences are described by many people as pleasant or profound, some may find it frightening or difficult. While there may be periods of discomfort in your experience, and occasionally following it (as outlined below), study staff will be there to support you throughout the medicine session and the whole way through your participation in this study. Psilocybin can also cause temporary dizziness, nausea, vomiting, headaches, and increased heart rate and blood pressure at this dose. These symptoms usually can begin 20 to 30 minutes after taking the drug and can last up to 6 hours. A mild headache is common following psilocybin treatment and can last for 1-2 days. It is safe to take over-the-counter medications such as Advil or Tylenol (unless you have been told to avoid combining such medication with other medications or therapies you are already taking for your underlying diagnosis). Please see Table 1 on the following page which displays the most common immediate side effects experienced when psilocybin is consumed at the dose you will have if you participate in this study (25mg). Medically trained treatment team staff have medications and equipment to treat patients in the case of an emergency. The medical doctor present may offer you medications for nausea, headaches or anxiety if they feel you require these. In rare cases, patients may feel intensely afraid during their experience. This may include feelings of anxiety, agitation, and paranoia. This is sometimes referred to as a ‘bad trip’. Data suggests that thorough preparation prior to a psilocybin session, as well as management of expectations, a strong sense of being supported and a welcoming, calm, safe environment during a psilocybin help to reduce the chances of difficult experiences and can enhance the sense of meaningfulness of the experience. (Borkel et al., 2024; Breeksema et al., 2024; Hartogsohn et al., 2024). While having a totally positive experience cannot be guaranteed, the study treatment team will provide you with all the information and tools needed to feel prepared for your psilocybin session. For example, you will learn about the concepts of “set” and “setting” (defined above on page 5) and how each contribute to your sense of feeling well-prepared before the psilocybin experience and safe and supported during the psilocybin experience. This information will be covered in your weekly CoP sessions leading up to the psilocybin treatment session and you will have plenty of time to ask questions. As with all effects of psilocybin, these feelings and sensations fade as the psilocybin wears off. Study staff will always be nearby to provide support, care, and reassurance should you begin to feel afraid or uncomfortable during your experience. If the fear and/or discomfort of the experience causes a participant to desire to leave the group treatment space, study staff are trained help guide the participant to a safe, private space for additional support and monitoring and may give you medications to help them become calmer. To accommodate the length of the treatment session, any additional care that is needed, and for time to slowly transition before going home, please plan for an 8-hour window of time to be at the study health centre during your PaT session day. Following the psilocybin treatment session, we will be checking in with you once a week to ensure your physical and emotional well-being.

Table 1: Most Common Acute Adverse of Therapeutic Doses of Psilocybin

The following table of adverse events is taken from pooled data described in a systematic review and meta-analysis by Yerubandi et al., 2024 where 15-25mg psilocybin was consumed by study participants in trials investigating treatment-resistant depression and or cancer-related depression and anxiety. Sample sizes were 29-104 study participants. Adverse effects are displayed more common to less common. Ranges reflect data from multiple studies.

 

.

E217BB20-F01C-43D8-9AA8-72F450A3CDAB_4_5005_c.jpeg

Short-Term effects of psilocybin (1-7 days): Some effects can persist for a few days after taking psilocybin. This may include the pleasant aspects of your experience as well as the less than pleasant. In the following days, up to 60% of patients may experience fatigue, exhaustion, and the need for extra sleep. Other effects are uncommon (less than 5%) these may include restless legs, headaches, difficulty concentrating, a sense of confusion or disconnection from your body, and emotional changes which may include sadness, anxiety, and irritability. (Carhart-Harris et al. 2016; Garcia-Romeu et al., 2021; Griffiths et al, 2016; Studerus et al., 2011; Ross et al., 2016; Yerubandi et al., 2024) These effects are temporary but should be shared with study staff at your weekly phone check-ins. If you feel you need any extra support, you can reach out to the study personnel, and we will readily provide you the supports you may require.

Long-Term Effects of Psilocybin (7 days to 3 months): Research indicates that long term adverse reactions to psilocybin such as ‘flashbacks’ (brief, unexpected, re-experiencing of a some of the sensations or hallucinations present in a psilocybin session), depression, or psychosis are exceedingly rare (

Risks and Discomforts from Standard Treatment

The risks and side-effects of the standard or usual treatments of medication and therapy will be explained to you as part of your care during the study.  If you are unclear about what is standard and what is specifically part of this study, please discuss this with your study doctor.  

Reproductive Risks Because the effects that psilocybin may have on a fetus are unknown, you should not become pregnant or father a baby while participating in this study. An effective method to avoid pregnancy is required to be used while you are in the study. If you are able to become pregnant, you will be required to have a negative urine pregnancy test 24-48 hours prior to the psilocybin administration. Ask the study doctor about counseling and more information about preventing pregnancy. If you (or your partner) become pregnant while you are on this study, you should notify your study doctor, you will be ineligible for the psilocybin administration, however, you may still continue with the Community of Practice sessions.

Confidentiality Risks Your privacy and confidentiality are of utmost importance. As discussed on page 3 of this document, the research team takes special care to ‘de-identify’ your personal information in the data collection platform. As such, when publishing a summary of the data, no individual participant contributions will be personally identifiable. Quotations from the end of treatment qualitative questionnaire may be published but will not be in any way linked to your personal information. The research team aims to not disclose the identity of participants but because of the small and potentially familiar study population, there is a risk that participants may be indirectly identifiable. Additionally, each Community of Practice group has a set of ‘Intentions and Agreements’. This is a list of standards by which all participants must mutually agree upon to conduct themselves within the group. These agreements will be introduced, reviewed, and amended if needed at the beginning of the 10-week CoP program. As part of these agreements, study participants commit to keeping all group member disclosures confidential during and after CoP sessions. Despite all of the above precautions, there still may be a risk that confidentiality is compromised by other participants. Because it is a group session, the study team cannot give absolute assurances that what was discussed in the CoP will remain confidential.

Risks of Community of Practice

The CoP gatherings can feel vulnerable and/or emotionally challenging at times, as such, you may find you become upset or fatigued following group sessions. If you require additional support in and around CoP sessions, you may reach out to your facilitators. 

 

What are the potential benefits to participating? 

There may not be direct benefit to you from taking part in this study. We hope that the information learned from this study can be used in the future to benefit other people with similar disease.

 

What are the alternatives to study treatment? 

If you choose not to participate in this study or to withdraw at a later date, standard treatments of medication and therapy are available to you, including a Community of Practice program without the psilocybin session. You can discuss these options with your doctor before deciding whether or not to participate in this research study.

After the study is finished

You may not be able to receive the study treatment after your participation in the study is approved and/or completed. There are several possible reasons for this, some of which are: 

 

  •   The treatment may not turn out to be effective or safe;

  •   The treatment may not be approved for use in Canada;

  •   Your caregivers may not feel it is the best option for you;

  •   You may decide it is too expensive to participate, and insurance coverage may not be available. The treatment, even if approved in Canada, may not be available free of charge.

 

A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law and Health Canada. This website will not include information that can identify you. At most, the website will include a summary of the results. You can search this website at any time. 

If you would like a copy of the results of this clinical study, please contact the Vancouver Island Health Authority [NK1] or SATA Centre for Conscious Living and we will provide you with a copy of any publications generated from this study.

 

What if new information becomes available that may affect my decision to participate?

If you choose to enter this study and during the study a more effective treatment becomes available, it will be discussed with you. You will also be advised of any new information that becomes available that may affect your willingness to remain in this study.  You may be invited to sign an amended consent to indicate your continued consent to participate in the study.  

 

What happens if I withdrawal my consent to participate in the study?

You may withdraw from this study at any time without giving reasons for your withdrawal. If you choose to enter the study and then decide to withdraw at a later time, all information about you collected up to the point of your withdrawal will be retained for analysis in order to protect the integrity of the research, which may benefit future research participants and patients. However, no further information will be collected. If you decide to withdraw, we will still contact you to ensure your safety and wellbeing.

You are also welcome to remain a participant in the Community of Practice sessions even if you decide you do not want to take the psilocybin.

 

Can I be asked to leave the study?

You may be asked to leave the study if the study doctor determines it is not in your best interest to continue because of medical or psychiatric issues, or if you are unable to fulfill the requirements for the study (such as missing more than 1 CoP sessions), or for any other reason. If you are asked to leave the study, the reasons for this will be explained to you and you will have the opportunity to ask questions about this decision. The study doctor will arrange for you to continue your care outside of the study.

The study may also be stopped at any time by the study Sponsor, the Research Ethics Board, or Health Canada if new information arises about the safety of the study treatment. The reasons for study stoppage will be explained to you by the study doctor.

 

What if I miss CoP (group therapy) sessions?

If you miss a CoP session for any reason, you will be asked to consider the discussion topic for the week and to discuss it with your facilitator before the next CoP.  It is very important to understand that if you miss more than 1 CoP session, you will not be able to receive the psilocybin.  We have found that participants that miss more than 1 session, are not adequately prepared for the psilocybin session.  Missing multiple sessions often alters the dynamics of the group, so you may remain in the CoP only if the facilitator feels it is reasonable to continue. 

 

How will my taking part in the study be kept confidential? Your confidentiality will be respected. However, research records and health or other source records identifying you may be inspected in the presence of a Health Canada inspector or designate, by representatives of Vancouver Island Health Authority, SATA Centre for Conscious Living, or the Island Health Research Ethics Board for the purpose of monitoring the research. No information or records that disclose your identity will be published without your explicit consent, nor will any information or records that disclose your identity be removed or released without your consent unless required by law. You will be assigned a unique study number as a participant in this study. This number will not include any personal information that could identify you (i.e., it will not include your Personal Health Number, Social Insurance Number, or your name or initials, etc.). This number keeps your identity confidential, and the number will only be used for research-related information collected about you during the course of this study. Information that contains your identity will only be accessible to the Qualified Investigator and Study Coordinator. The list that matches your name to this unique study number that is used on your research-related information will not be moved, shared, or released without your express consent unless required by law. Your demographic data such as your name, date of birth, address, phone number and personal health number as well as the physician notes from the weekly CoP will be held in a secure Electronic Medical Record. Study data is transferred to our secured data bank hosted by BC Children’s Hospital after your name and any other identifying information has been removed. All research data will be stored on secure servers with restricted access to only those on the research team. Your data is also collected via digital questionnaires you fill out directly, which are administered online and can be completed from your home on your phone, tablet or home computer. The results of these questionnaires are delivered, received, and held by a secured data bank hosted by BC Children’s Hospital. The email address you provide to the treatment team will only be used to send and receive study-related communications such as study visit reminders, study session details, engage in support with research team members and other participants (if desired) etc. You should be aware, however, that personal emails are not entirely secure and there is a risk when sending personal data via a personal email. Your de-identified data may be used for future research studies on the effectiveness of psilocybin without additional informed consent. You are encouraged to ask the study team about this if you have any questions. Please note, legal and professional ethical responsibilities do require disclosure of confidential personal information in very limited circumstances, such as where you threaten the bodily harm or death of yourself (i.e., suicidality) or others, or you report abuse regarding a child or vulnerable adult. If you have questions or concerns regarding the collection and use of your personal information, please discuss with your facilitator or other study team member. Your rights to privacy are legally protected by federal and provincial laws that require safeguards to ensure that your privacy is respected. You also have the legal right of access to the information about you that has been provided to the Sponsor and, if need be, an opportunity to correct any errors in this information. Further details about these laws are available by request to your study doctor.

Who can access what parts of my records?

As discussed on page 3 of this document, OWL is a electronic medical record platform held by SATA Centre for Conscious Living, used by study treatment team to document important psychiatric and medical information that is not captured elsewhere that is important for the research team to track. REDCap (also discussed on page 3) is the secure electronic data capture platform where research data is collected and stored.

 

The Study Coordinator can access your medical records on OWL and data on REDCap. The Qualified Investigator can access your de-identified data on REDCap.

In the event of safety concerns, the Medical Monitor can access your medical information in OWL and de-identified data on REDCap (only in the event of safety concerns).

Treatment team members will only access medical records on OWL.

Other Research Team members will only access your de-identified data on REDCap for data analysis.

 

How long will data be kept for?

Study records may be destroyed after 15 years, or earlier, if permitted by applicable regulatory requirements.

 

What will my data be used for?

Your de-identified data will be used by the research team in this study to determine whether the CoP model can be used for psilocybin-assisted therapy.  The data will be analyzed by the research team and published in a peer-reviewed journal.  De-identified data may be used in the future by researchers to compare the results of this study with the effectiveness of other treatments and therapies.

Researcher Relationship with Participants When practitioners investigate their own professional practices for quality improvement or research purposes, and there are patients for which they have a previously established relationship (for example, as a teacher, colleague, employee, spouse, dependent), this is called a “dual role”. Dual roles can also exist between team members, between a team member and a patient, or between two patients. While dual roles do not always cause problems, they do need to be discussed and managed, especially when involving positions of power of one person over another, or when participant confidentiality is a concern. To manage dual roles, all participants and study team members will be asked to disclose dual roles. If such roles exist the team will work with you to determine how best to manage, mitigating any potential risks. Some ways of managing these roles can be: Your screening, intakes and consent will be done by team members who are not involved in your previous or ongoing medical or mental health care. All information you supply during the study period will be collected by a team member not involved in your care and de-identified before data is collected for the study. Participants who know each other may request to be moved to another group. Facilitators will be changed, if a participant has previously, or is currently receiving care by them. Confidentiality will be upheld to the fullest extent possible, as previously discussed in this consent form. Dual Roles to declare in this study include: Dr. Valorie Masuda, Qualified Investigator, is a Palliative Care physician who may refer patients to the study. Dr. Kim Adzich, the Medical Monitor, is a Palliative Care physician who may refer patients to the study. Dr. Fraser Black is a Palliative Care physician, Dr. Christian Weins is psychiatrist (Oncology) and Dr. Edward Brooks is an Oncologist, all of whom may refer patients to the study. The study treatment team physicians, nurses, and therapists also work within SATA Centre for Conscious Living programs. There are no financial conflicts of interest to declare for this study.

Disclosure of Race/Ethnicity

Studies involving humans now routinely collect information on race and ethnic origin as well as other characteristics of individuals because these characteristics may influence how people respond to different medications. You should be aware that providing this information is not mandatory.

What happens if something goes wrong?

By signing this form, you do not give up any of your legal rights and you do not release the study doctor, participating institutions, or anyone else from their legal and professional duties. If you become ill or physically injured as a result of participation in this study, medical treatment will be provided at no additional cost to you. The costs of your medical treatment will be paid by your provincial medical plan and/or by the study sponsor, Vancouver Island Health Authority.

If any significant medical events occur, it is important for you to notify the research team. In case of a serious medical event, please report to an emergency room and inform them that you are participating in a clinical study and that the following person can then be contacted for further information: Dr. Valorie Masuda at: 250-710-3697 . The research team is required to report all significant medical events Health Canada. 

The weekly phone check-ins will also help identify if you are experiencing any adverse events during your study participation and to help determine if those events are related to study treatment or not. This includes things like undesirable side effects. This may include reviewing your hospital records, laboratory data or other investigations.

What will the study cost me?

All research-related medical care and treatment and any related tests that you will receive during your participation in this study will be provided at no cost to you.

Reimbursement

You will not be reimbursed for any expenses incurred for transport or accommodation to the study site.

Remuneration/Compensation

You will not be paid for your time participating in the study.

If I have questions about the study procedures during my participation, who should I speak to?

If you have any questions or desire further information about this study before or during participation, or if you experience any adverse effects, you can contact Dr. Valorie Masuda at valorie.masuda@islandhealth.ca

Who do I contact if I have any questions or concerns about my rights as a participant?

If you have any concerns about your rights as a research participant and/or your experiences while participating in this study, contact the Chair of the Island Health Research Ethics Board at (250) 519-6726. Please reference the study number (H22-02523).

If you wish to proceed to a screening visit to obtain more information about potentially becoming a participant in this study, please fill out this contact form

bottom of page