End of LifeEarly Phase 1NCT05958758
A Community of Practice Program With Psilocybin-assisted Therapy for End-of-Life Patients
A Early Phase 1 study testing Psilocybin-assisted therapy within a community of practice model (group administered) in people with End of Life, run by The Roots to Thrive Society for Psychedelic Therapy.
Trial summary
The purpose of the study is to understand the feasibility of a resilience focused community of practice program that includes psilocybin-assisted therapy for End-of-Life Distress. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- End of Life
- What is being tested?
- Psilocybin-assisted therapy within a community of practice model (group administered)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2023to 31 Oct 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must have a terminal diagnosis whereby there is a limited life expectancy (predicted life expectancy less than 2 years).
- Ages 19-80 years of age
- Male, menopausal female, if childbearing age not pregnant, using birth control and negative pregnancy test prior to psilocybin administration.
- Ambulatory (Palliative performance status 50% or greater)
- eGFR >20 ml/min ❏AST < 3xULN and bilirubin <50 umol/L
- Patient has emotional distress that has not successfully responded to other treatments: other treatments failed, patient could not tolerate other treatments, patient is unable to access other treatments, or patient refused other treatments for reasons acceptable to our treatment team.
- Patient demonstrates comprehension sufficient for understanding the consent form.
Who cannot join
- Treatment in a clinical trial where psilocybin therapy would disqualify them from their primary treatment trial.
- If female is:a) pregnant (positive pregnancy test),b) nursing,
- Currently taking on a regular (e.g., daily) basis: >investigational agents, >medications that are MAO inhibitors >UDG modulators, and inhibitors of UGT1A9 and 1A10, aldehyde or alcohol dehydrogenase inhibitors, SSRI's, SNRI's.
- Patients are given the option to wean themselves off their medications prior to the psilocybin to be included in the trial. Patients taking MAO-A inhibitors (especially the irreversible inhibitors) will require a minimum 2-week washout period. The possible concern over serotonin syndrome with these agents is not well documented in the literature, however the long interval before MAO is replenished may warrant a cautious approach based on the patient's risk factors and warrants oversight from the MRP (Most Responsible Physician)
- Patientstaking MAO-B inhibitors should be assessed on a case by case basis as there is a potential for a heightened response and warrants oversight from the MRP.
- Patients with known sensitivities to psilocybin and or its metabolites or have had significant adverse events after prior psilocybin or other psychedelic use.
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- Active uncontrolled epilepsy.
- Uncontrolled cardiovascular conditions: uncontrolled hypertension, uncontrolled angina, a clinically significant ECG abnormality (e.g. QT prolongation).
- Uncontrolled vascular disease (such as TIA in the last 3-6 months, stroke with loss in mental status, peripheral or pulmonary vascular disease with active claudication).
- Unstable Insulin-dependent diabetes;
- Conditions requiring special medical consideration:
- Cancer has central nervous system involvement.
- Paraneoplastic syndrome or a tumor with ectopic hormone production which may place the patient at risk for hypercalcemia, Cushing's syndrome, or SIADH secretion.
- Psychiatric Exclusion Criteria:
- Severity of depression or anxiety symptoms warranting immediate emergent treatment with antidepressant or daily anxiolytic medication as these patients would require immediate referral to community psychiatry.
- Current or past history of meeting DSM-5 criteria for:
- (the following diagnoses must have been confirmed by a qualified psychiatrist or psychologist):
- Schizophrenia;
- Psychotic Disorder (unless substance-induced or due to a medical condition);○ Borderline Personality Disorder;
- Bipolar I Disorder;
- Bipolar II Disorder;
- Other psychiatric conditions judged to be incompatible with establishment of rapport or safe exposure to psilocybin.
- Borderline Personality Disorder, Bipolar I Disorder and Bipolar II Disorder may be considered after a psychiatric consult.
- Bipolar I would require more in-depth investigation in relation to the history of manic episodes.
- Meet DSM-5 criteria for Dissociative Disorder
- Concurrent use of illicit drugs causing ongoing intoxication
- Unstable housing conditions (homelessness)
- First degree relatives meet DSM-5 criteria for Bipolar Disorder or Schizophrenia
About this study
Official title: An Open Label Pragmatic Feasibility Study on a Resilience Focused Community of Practice Program With Psilocybin-assisted Therapy (PaT) for End-of-Life Patients.
The purpose of the study is to understand the feasibility of a resilience focused community of practice program that includes psilocybin-assisted therapy for End-of-Life Distress. The community of practice refers to a research informed group therapy process that runs over a 10-week period of time and includes one group administered psilocybin-assisted therapy session.
Target population: The treatment team will treat a total of 64 patients who have:
- a terminal diagnosis (experiencing end of life distress),
- AND who are eligible for the RTT + Psilocybin-assisted Therapy Treatment program through the RTT Society.
Read the detailed description
Treatment will take place at the Snuneymuxw Traditional Medicines Clinic, 1984 Woobank Rd, Nanaimo, B.C.Research data will be coordinated and held through RedCap, hosted by Island Health.
Data collection centres on 1) understanding the feasibility; 2) collecting safety data; 3) exploring the mental health impacts of a community of practice as the vessel for psilocybin-assisted therapy for those with end-of-life distress.
There is a mixed method approach for data collection, including:
- Collect attendance
- Biomedical measures taken during psilocybin sessions (blood pressure, pulse, medications to manage side effects).
- Quantitative Health and Wellness Questionnaires of participants before, within, immediately after, and six months after completion.
- Qualitative Surveys and Exit Interviews.
- Conditions
- End of Life
- Being tested
- Psilocybin-assisted therapy within a community of practice model (group administered)
- Medical subject headings
- Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psilocybin-assisted therapy within a community of practice model (group administered)Drug
The community of practice is 10 weeks long, meeting virtually for 2 hours each week, in a structured process, run through the Roots to Thrive treatment program. The psilocybin-assited therapy sessions occur midway through the 10-week program.
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | Group administered Psilocybin-assisted therapy Receives: Drug: Psilocybin-assisted therapy within a community of practice model (group administered) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome 1: Treatment Intervention Phase - Safety Monitoring: Adverse events (AEs), serious adverse events (SAEs) and treatment emergent adverse events (TEAEs)
Safety in the trial will be evaluated by monitoring AEs, SAEs, and TEAEs over the 10-week intervention period. Adverse events will be defined and documented according to the adverse reporting procedures and be collected via self-report, report from others, or chart abstraction.
Measured: Treatment intervention period: Weeks 1 through 10
Primary Outcome 2: Follow-up to Treatment Phase - Safety Monitoring: Adverse events (AEs), serious adverse events (SAEs) and treatment emergent adverse events (TEAEs)
Safety in the trial will be evaluated by monitoring AEs, SAEs, and TEAEs during the 30-day treatment intervention follow-up phase. Adverse events will be defined and documented according to the adverse reporting procedures and be collected via self-report, report from others, or chart abstraction.
Measured: Follow-up period: Weeks 10 through 14
Primary Outcome 3: Safety Monitoring: Biomedical measures - Pregnancy testing
A urine pregnancy test measuring beta-human chorionic gonadotropin (B-hCG) will be conducted on the pre-treatment targeted physical exam visit to ensure the participant is not pregnant. If the pregnancy test is positive, the participant will be unable to participate in the treatment intervention at Week 5 but will be invited to remain in group therapy interventions sessions (Weeks 1-10).
Measured: Immediately prior to treatment intervention session (Week 5)
Primary Outcome 3: Safety Monitoring: Biomedical measures - Heart Rate
Vitals signs, including heart rate (beats per minute/BPM) will be measured before, during, and after the treatment intervention session.
Measured: Treatment intervention session (Week 5)
Primary Outcome 3: Safety Monitoring: Biomedical measures - Blood Pressure
Vitals signs, including blood pressure (millimeters of mercury/mmHg) will be measured before, during, and after the treatment intervention session.
Measured: Treatment intervention session (Week 5)
Secondary outcomes (2)
Feasibility Outcome 1: Attendance during study intervention.
Feasibility outcomes will be measured using standardized assessments of treatment retention (i.e., partucipant attendance) Treatment retention will be defined as attendance in 80 % of the CoP group therapy sessions (>2 consecutive sessions) and attendance at the Week 5 psilocybin therapy session.
Measured: Weeks 1-10
Feasibility Outcome 2: Post-treatment intervention Qualitative Survey
Upon completing the 10-week intervention period, all participants will complete the Roots to Thrive (RTT)-Psychedelic Assisted Therapy (PAT) Global QI Survey by answering seven (7) standard questions. Each participant will answer the same 7 questions. This survey will be administered by a member of the study team, and each question will be completed by the participant via online entry.
Measured: End of treatment intervention period: Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start1 Sep 2023 (estimated)
- Primary completion30 Apr 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Roots to Thrive Society for Psychedelic Therapy
- Sponsor type
- University, hospital or other
- Collaborators
- Vancouver Island Health Authority, Vancouver Island University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05958758
- Sponsor's protocol ID
- H22-02523
- Status last verified
- Jul 2023
- First submitted
- 23 Feb 2023
- Last updated
- 25 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Pragmatic Feasibility Study on a Resilience Focused Community of Practice Program With Psilocybin-assisted Therapy (PaT) for End-of-Life Patients.
- ClinicalTrials.gov ID
- NCT05958758
- Acronym / sponsor ID
- H22-02523
- Conditions
- End of Life
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- The Roots to Thrive Society for Psychedelic TherapyUniversity, hospital or other
- Collaborators
- Vancouver Island Health Authority, Vancouver Island University
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 25 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to understand the feasibility of a resilience focused community of practice program that includes psilocybin-assisted therapy for End-of-Life Distress. The community of practice refers to a research informed group therapy process that runs over a 10-week period of time and includes one group administered psilocybin-assisted therapy session.
Target population: The treatment team will treat a total of 64 patients who have:
- a terminal diagnosis (experiencing end of life distress),
- AND who are eligible for the RTT + Psilocybin-assisted Therapy Treatment program through the RTT Society.
Detailed description
Treatment will take place at the Snuneymuxw Traditional Medicines Clinic, 1984 Woobank Rd, Nanaimo, B.C.Research data will be coordinated and held through RedCap, hosted by Island Health.
Data collection centres on 1) understanding the feasibility; 2) collecting safety data; 3) exploring the mental health impacts of a community of practice as the vessel for psilocybin-assisted therapy for those with end-of-life distress.
There is a mixed method approach for data collection, including:
- Collect attendance
- Biomedical measures taken during psilocybin sessions (blood pressure, pulse, medications to manage side effects).
- Quantitative Health and Wellness Questionnaires of participants before, within, immediately after, and six months after completion.
- Qualitative Surveys and Exit Interviews.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Drug: Psilocybin-assisted therapy within a community of practice model (group administered)Group administered Psilocybin-assisted therapy |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient must have a terminal diagnosis whereby there is a limited life expectancy (predicted life expectancy less than 2 years).
- Ages 19-80 years of age
- Male, menopausal female, if childbearing age not pregnant, using birth control and negative pregnancy test prior to psilocybin administration.
- Ambulatory (Palliative performance status 50% or greater)
- eGFR >20 ml/min ❏AST < 3xULN and bilirubin <50 umol/L
Key exclusion criteria (28 listed)
- Treatment in a clinical trial where psilocybin therapy would disqualify them from their primary treatment trial.
- If female is:a) pregnant (positive pregnancy test),b) nursing,
- Currently taking on a regular (e.g., daily) basis: >investigational agents, >medications that are MAO inhibitors >UDG modulators, and inhibitors of UGT1A9 and 1A10, aldehyde or alcohol dehydrogenase inhibitors, SSRI's, SNRI's.
- Patients with known sensitivities to psilocybin and or its metabolites or have had significant adverse events after prior psilocybin or other psychedelic use.
- Active uncontrolled epilepsy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psilocybin-assisted therapy within a community of practice model (group administered)The community of practice is 10 weeks long, meeting virtually for 2 hours each week, in a structured process, run through the Roots to Thrive treatment program. The psilocybin-assited therapy sessions occur midway through the 10-week program. | Drug | Single arm |
Primary outcome
Primary Outcome 1: Treatment Intervention Phase - Safety Monitoring: Adverse events (AEs), serious adverse events (SAEs) and treatment emergent adverse events (TEAEs)
Time frame: Treatment intervention period: Weeks 1 through 10
Safety in the trial will be evaluated by monitoring AEs, SAEs, and TEAEs over the 10-week intervention period. Adverse events will be defined and documented according to the adverse reporting procedures and be collected via self-report, report from others, or chart abstraction.
Primary Outcome 2: Follow-up to Treatment Phase - Safety Monitoring: Adverse events (AEs), serious adverse events (SAEs) and treatment emergent adverse events (TEAEs)
Time frame: Follow-up period: Weeks 10 through 14
Safety in the trial will be evaluated by monitoring AEs, SAEs, and TEAEs during the 30-day treatment intervention follow-up phase. Adverse events will be defined and documented according to the adverse reporting procedures and be collected via self-report, report from others, or chart abstraction.
Primary Outcome 3: Safety Monitoring: Biomedical measures - Pregnancy testing
Time frame: Immediately prior to treatment intervention session (Week 5)
A urine pregnancy test measuring beta-human chorionic gonadotropin (B-hCG) will be conducted on the pre-treatment targeted physical exam visit to ensure the participant is not pregnant. If the pregnancy test is positive, the participant will be unable to participate in the treatment intervention at Week 5 but will be invited to remain in group therapy interventions sessions (Weeks 1-10).
Primary Outcome 3: Safety Monitoring: Biomedical measures - Heart Rate
Time frame: Treatment intervention session (Week 5)
Vitals signs, including heart rate (beats per minute/BPM) will be measured before, during, and after the treatment intervention session.
Primary Outcome 3: Safety Monitoring: Biomedical measures - Blood Pressure
Time frame: Treatment intervention session (Week 5)
Vitals signs, including blood pressure (millimeters of mercury/mmHg) will be measured before, during, and after the treatment intervention session.
2 secondary outcomes
Feasibility Outcome 1: Attendance during study intervention.
Time frame: Weeks 1-10
Feasibility Outcome 2: Post-treatment intervention Qualitative Survey
Time frame: End of treatment intervention period: Week 10
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Psilocybin-assisted therapy within a community of practice model (group administered) in people with End of Life, run by The Roots to Thrive Society for Psychedelic Therapy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome 1: Treatment Intervention Phase - Safety Monitoring: Adverse events (AEs), serious adverse events (SAEs) and treatment emergent adverse events (TEAEs) (time frame: Treatment intervention period: Weeks 1 through 10). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2023; AzTrials last refreshed its copy on 31 Oct 2026.