Advanced CancerPhase 2PAT-MINDNCT07791901
MB-PAT for Demoralization in Advanced Cancer ('PAT-MIND') Trial
A Phase 2 study testing PEX010 25 mg psilocybin, PEX010 5 mg psilocybin and Standard Psilocybin-Assisted Therapy in people with Advanced Cancer and Demoralization, run by University of Calgary at 2 sites in Canada.
Trial summary
This pilot clinical trial will study psilocybin-assisted therapy for adults with advanced cancer who are experiencing demoralization, existential distress, or related psychological concerns. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer, Demoralization, Existential Distress
- What is being tested?
- PEX010 25 mg psilocybin, PEX010 5 mg psilocybin and Standard Psilocybin-Assisted Therapy
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesCanada
- Study dates
- 30 Oct 2026to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent provided before any study-specific procedures.
- Age 18 years or older.
- Diagnosis of advanced cancer: Stage III-IV or metastatic solid tumor. Stage II cancer may be eligible if the treating oncologist confirms advanced/refractory disease with clinically significant existential burden, defined as a Demoralization Scale-II (DS-II) score ≥11.
- Clinical life expectancy of at least 6 months. Borderline cases of approximately 5-6 months may be considered based on Principal Investigator judgment and documentation.
- Demoralization Scale-II (DS-II) total score ≥4 at screening, or DS-II total score ≥3 with documented clinical impression of significant existential distress.
- Willing and cognitively able to complete at least 2 preparation sessions, 1 in-person dosing session, and at least 2 integration sessions over approximately 6-8 weeks.
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- Sufficient spoken and written English proficiency to provide informed consent, participate in group therapy, and complete participant-reported outcome measures.
- Not pregnant or lactating. Participants of childbearing potential must have a negative pregnancy test at screening and comply with protocol-specified contraception requirements.
- A responsible adult, such as a family member, friend, or caregiver, must be available to accompany the participant or be on-call for at least 12 hours following the dosing session.
Who cannot join
- Psychiatric/Psychological:
- Active or high-risk suicidality, defined as Columbia-Suicide Severity Rating Scale (C-SSRS) item 4 or 5 within the past 4 weeks, or a suicide attempt within the past 12 months. Passive death wishes and suicidal ideation without intent are not exclusionary.
- Current psychotic disorder or active psychotic symptoms, including schizophrenia, schizoaffective disorder, hallucinations, delusions, or thought disorganization. Historical psychosis in sustained remission may be considered on a case-by-case basis by the Principal Investigator.
- Current manic or mixed-state episode. Stable, euthymic bipolar disorder on maintenance pharmacotherapy may be permitted with Principal Investigator judgment and documentation.
- Moderate-to-severe active alcohol, stimulant, or opioid use disorder within the past 12 months. Severe uncontrolled cannabis use disorder is exclusionary; stable prescribed cannabis use is permitted.
- Pharmacological/Drug Interactions:
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- Use of concomitant medications that does not meet the requirements of the protocol-specified Concomitant Medications Policy.
- Known allergy, anaphylaxis, or serious hypersensitivity to psilocybin, psilocin, related tryptamines, or capsule excipients.
- Medical:
- Severe hepatic impairment, defined as a current unstable diagnosis of liver disease with AST or ALT >5 times the upper limit of normal and clinical symptoms.
- Severe renal impairment, including current unstable acute kidney injury or advanced kidney disease (CKD Stage 4) with eGFR <30 mL/min/1.73 m².
- Unstable cardiovascular disease, including myocardial infarction or stroke within the past 3 months, decompensated heart failure (NYHA III-IV), or uncontrolled arrhythmia. Elevated blood pressure on dosing day may require dosing deferral and reassessment according to protocol-defined thresholds.
- Seizure within the past 12 months or currently uncontrolled epilepsy. Well-controlled epilepsy with no seizures for more than 12 months on stable therapy may be permitted with monitoring.
- Uncontrolled diabetes, including unstable Type 1 diabetes with diabetic ketoacidosis within the past 3 months, or Type 2 diabetes with HbA1c >11% and symptomatic hyperglycemia.
- Any medical, neurological, or psychiatric condition, or concurrent cancer-directed therapy, that in the Principal Investigator's clinical judgment would materially increase risk or prevent meaningful protocol participation.
- Cancer Treatment-Related:
- Systemic anti-cancer therapy that does not meet protocol requirements. Chemotherapy, immunotherapy, and targeted therapy are permitted when the regimen is stable, treatment-related toxicities are CTCAE Grade 2 or lower, and protocol-specified timing requirements before psilocybin dosing are met.
- Opioid analgesic or corticosteroid use that does not meet protocol requirements. Opioids must be on a stable dose for at least 1 week without opioid-induced delirium or clinically significant respiratory compromise. Corticosteroids must generally be stable for at least 2 weeks; high-dose dexamethasone for acute central nervous system edema requires dosing to be deferred until clinically stable.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Chantal Savard, BA contact
Canada2 sites
Arthur Child Comprehensive Cancer Centre
Calgary, Alberta, T2N 4N1
Christopher P. Albertyn, PhD, 587-231-3984, christopher.albertyn@ucalgary.ca
Chantal Savard, BA, 587-231-3965, chantal.savard1@ucalgary.ca
Providence Care Hospital
Kingston, Ontario, K7L 4X3
Claudio N Soares, MD, PhD, FRCPC, MBA, claudio.soares@kingstonhsc.ca
Ron Shore, MPA, PhD
About this study
Official title: High vs. Low-Dose Group-Based Psilocybin-Assisted Therapy (PAT) With or Without Mindfulness-Based (MB) Preparation and Integration for Demoralization in Adults With Advanced Cancer (PAT-MIND): A Pilot Feasibility 2x2 Factorial Multisite Trial
This pilot clinical trial will study psilocybin-assisted therapy for adults with advanced cancer who are experiencing demoralization, existential distress, or related psychological concerns. Demoralization can include feelings of hopelessness, helplessness, loss of meaning, and distress related to illness or end of life.
The purpose of this study is to assess whether a hybrid group-based psilocybin-assisted therapy program is feasible, acceptable, and safe in adults with advanced cancer. The study will also explore which combination of psilocybin dose and psychotherapy approach may be most promising for a future larger trial.
Participants will be randomly assigned by wave to one of four intervention combinations: 25 mg psilocybin with mindfulness-based psilocybin-assisted therapy, 25 mg psilocybin with standard psilocybin-assisted therapy, 5 mg psilocybin with mindfulness-based psilocybin-assisted therapy, or 5 mg psilocybin with standard psilocybin-assisted therapy. The psilocybin dose will be blinded, meaning participants and some members of the study team will not know which dose was assigned. Psychotherapy approach will not be blinded. The study will enroll at least 60 participants across Calgary and Kingston.
Read the detailed description
PAT-MIND is a multi-site, phase IIb pilot feasibility and therapy-optimization trial of psilocybin-assisted therapy in adults with advanced cancer. The study uses a wave-randomized 2×2 factorial design to examine two intervention components: psilocybin dose and psychotherapy intensity. Participants will be enrolled in small waves, and each wave will be randomized to one of four combinations: high-dose psilocybin plus mindfulness-based psilocybin-assisted therapy, high-dose psilocybin plus standard psilocybin-assisted therapy, low-dose psilocybin plus mindfulness-based psilocybin-assisted therapy, or low-dose psilocybin plus standard psilocybin-assisted therapy.
The psilocybin dose comparison is blinded. Participants will receive either 25 mg or 5 mg psilocybin during a monitored in-person group dosing session. The psychotherapy intensity comparison is not blinded. Participants will receive either mindfulness-based psilocybin-assisted therapy or standard psilocybin-assisted therapy, depending on their randomized intervention combination. Preparation and integration sessions will be delivered using a hybrid format, with some sessions conducted in person and some virtually, depending on the session type and site logistics.
The primary aims of this pilot trial are to assess the feasibility, acceptability, and safety of hybrid group-based psilocybin-assisted therapy in adults with advanced cancer, and to explore therapy-optimization signals for psilocybin dose and psychotherapy intensity to inform a future definitive trial. Exploratory objectives include participant experience, demoralization, secondary psychological outcomes, health-related quality of life, health-economic measures, and exploratory biomarker outcomes.
Study procedures include screening, informed consent, trial-specific questionnaires, group and individual preparation and integration sessions, a monitored psilocybin dosing day, dried blood spot collection, stool sample collection, optional wearable device data collection, and medical chart review. Participants will complete online questionnaires at protocol-defined timepoints, including measures of demoralization, psychological distress, quality of life, treatment experience, and resource use.
Safety will be monitored throughout the study, including adverse event monitoring during and after the dosing session.
- Being tested
- PEX010 25 mg psilocybin, PEX010 5 mg psilocybin, Standard Psilocybin-Assisted Therapy, Mindfulness-Based Psilocybin-Assisted Therapy
- Keywords
- psychedelics, psilocybin, cancer, demoralization, late-stage, psychedelic-assisted therapy, PAT, Mindfulness, existential distress
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEX010 25 mg psilocybinDrug
Also called Psilocybin, PEX010
Participants randomized to this dose condition will receive a single 25 mg oral dose of PEX010 (psilocybin) during a monitored in-person group dosing session, together with protocol-defined psychotherapeutic support
PEX010 5 mg psilocybinDrug
Also called Psilocybin, PEX010, low-dose psilocybin
Participants randomized to this dose condition will receive a single 5 mg oral dose of PEX010 (psilocybin) during a monitored in-person group dosing session, together with protocol-defined psychotherapeutic support. This is a blinded low-dose active comparator condition.
Standard Psilocybin-Assisted TherapyBehavioural
Also called Standard PAT, PAT
Participants randomized to this psychotherapy condition will receive standard psilocybin-assisted therapy, including protocol-defined preparation, dosing-day support, and integration sessions. The intervention is delivered in a hybrid format, with some sessions conducted in person and some virtually, depending on session type and site logistics.
Mindfulness-Based Psilocybin-Assisted TherapyBehavioural
Also called MB-PAT, Mindfulness-Based PAT
Participants randomized to this psychotherapy condition will receive mindfulness-based psilocybin-assisted therapy, including protocol-defined preparation, dosing-day support, and integration sessions. The intervention includes mindfulness-based therapeutic elements and is delivered in a hybrid format, with some sessions conducted in person and some virtually, depending on session type and site logistics.
| Study group | Role | What they receive |
|---|---|---|
| 25 mg Psilocybin + Standard PAT | Experimental | Not described Receives: Drug: PEX010 25 mg psilocybin; Behavioral: Standard Psilocybin-Assisted Therapy |
| 25 mg Psilocybin + Mindfulness-Based PAT | Experimental | Not described Receives: Drug: PEX010 25 mg psilocybin; Behavioral: Mindfulness-Based Psilocybin-Assisted Therapy |
| 5 mg Psilocybin + Standard PAT | Experimental | Not described Receives: Drug: PEX010 5 mg psilocybin; Behavioral: Standard Psilocybin-Assisted Therapy |
| 5 mg Psilocybin + Mindfulness-Based PAT | Experimental | Not described Receives: Drug: PEX010 5 mg psilocybin; Behavioral: Mindfulness-Based Psilocybin-Assisted Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Trial Feasibility Based on Prespecified RED/YELLOW/GREEN Progression Criteria
Overall trial feasibility will be assessed using prespecified progression criteria covering recruitment, intervention delivery, and retention. Component metrics include screening completion among referred individuals, eligibility among screened individuals, enrollment among eligible individuals, preparation-session attendance, integration-session attendance, completion of the 1-week post-dose assessment (A3), and completion of the 3-month follow-up (A5). Each component will be expressed as a proportion and classified according to prespecified RED (review), YELLOW (amend), or GREEN (go) thresholds. The overall feasibility classification will be determined by the worst-performing component, resulting in a single overall RED/YELLOW/GREEN progression classification. Feasibility will be assessed pooled across all four intervention arms.
Measured: From initial referral/screening through the 3-month follow-up (A5), up to approximately 4 months
Incidence of Adverse Events (AEs)
Safety will be assessed in all participants who receive psilocybin. Adverse events will be collected from informed consent through the 3-month follow-up (A5) and summarized as the number and proportion of participants experiencing one or more adverse events. Events will be characterized by severity, relationship to psilocybin, dose group, and timing. Serious adverse events (SAEs) and protocol-defined adverse events of special interest (AESIs) will be identified and summarized as prespecified safety categories.
Measured: From informed consent through the 3-month follow-up (A5), approximately up to 4 months
Secondary outcomes (9)
Change in Demoralization Scale-II (DS-II) Total Score
Demoralization will be assessed using the Demoralization Scale-II (DS-II), a 16-item self-report measure. Each item is scored from 0 to 2, yielding a total score ranging from 0 to 32. Higher scores indicate greater demoralization (a worse outcome). The outcome is the change in DS-II total score from baseline (A1) to 1 week post-dosing (A3).
Measured: Baseline to 1 week post-dose
Change in anxiety symptoms assessed by PROMIS Anxiety Short Form 8a
Anxiety symptoms will be assessed using the 8-item PROMIS Anxiety Short Form 8a. Change in anxiety will be evaluated from baseline across post-dose follow-up assessments.
Measured: Baseline through 3 months post-dose
Change in depressive symptoms assessed by PROMIS Depression Short Form 8a
Depressive symptoms will be assessed using the 8-item PROMIS Depression Short Form 8a. Change in depressive symptoms will be evaluated from baseline across post-dose follow-up assessments.
Measured: Baseline through 3 months post-dose
Change in Death and Dying Distress Scale (DADDS) Total Score
Death and dying distress will be assessed using the 15-item Death and Dying Distress Scale (DADDS). Each item is scored from 0 to 5, yielding a total score ranging from 0 to 75. Higher scores indicate greater death and dying distress and therefore a worse outcome. Change in DADDS total score will be evaluated from baseline across post-dose follow-up assessments.
Measured: Baseline through 3 months post-dose
Change in Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being 12-Item Scale (FACIT-Sp-12) Score
Spiritual well-being will be assessed using the 12-item Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being scale (FACIT-Sp-12). Change in spiritual well-being will be evaluated from baseline across post-dose follow-up assessments.
Measured: Baseline through 3 months post-dose
Change in PROMIS Pain Intensity Score
Pain intensity will be assessed using the 3-item PROMIS Pain Intensity measure. Change in pain intensity will be evaluated from baseline across post-dose follow-up assessments.
Measured: Baseline through 3 months post-dose
Change in PROMIS Pain Interference Score
Pain interference will be assessed using the 4-item PROMIS Pain Interference measure. Change in pain interference will be evaluated from baseline across post-dose follow-up assessments.
Measured: Baseline through 3 months post-dose
Change in EuroQol Five-Dimension Five-Level (EQ-5D-5L) Health Utility Score
Health-related quality of life will be assessed using the EuroQol Five-Dimension Five-Level Questionnaire (EQ-5D-5L). Responses across the five dimensions will be converted to health-utility values using an appropriate validated value set. Change in health utility will be evaluated across follow-up.
Measured: Baseline through 3 months post-dose
Change in Mindfulness Assessed by the Mindful Allowance 8-Item Short Form
Mindfulness will be assessed using the Mindful Allowance 8-Item Short Form, a PROMIS-based self-report measure. Change in mindfulness will be evaluated from baseline across post-dose follow-up assessments. Higher scores indicate greater mindful allowance/mindfulness.
Measured: Baseline through 3 months post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start30 Oct 2026 (estimated)
- Primary completion20 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Phase IIb pilot feasibility and therapy-optimization trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Providence Care, Kingston, ON, Canada
- Responsible party
- Principal investigator, Linda E. Carlson, University of Calgary
- Investigators
- Linda E. Carlson, Ph.D., R.Psych, FCAHS, FABMR, Principal investigator, University of CalgaryRon Shore, MPA, PhD, Principal investigator, Queen's UniversityHarriet Richardson, MSc, PhD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07791901
- Sponsor's protocol ID
- HREBA.CC-24-0258
- Acronym
- PAT-MIND
- Status last verified
- Aug 2026
- First submitted
- 6 Aug 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A final decision regarding sharing of de-identified individual participant data has not yet been made. Any future data sharing will be subject to participant consent, research ethics approval, applicable privacy legislation, institutional requirements, and approval by the Trial Steering Committee.
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High vs. Low-Dose Group-Based Psilocybin-Assisted Therapy (PAT) With or Without Mindfulness-Based (MB) Preparation and Integration for Demoralization in Adults With Advanced Cancer (PAT-MIND): A Pilot Feasibility 2x2 Factorial Multisite Trial
- ClinicalTrials.gov ID
- NCT07791901
- Acronym / sponsor ID
- PAT-MIND / HREBA.CC-24-0258
- Keywords
- psychedelics, psilocybin, cancer, demoralization, late-stage, psychedelic-assisted therapy, PAT, Mindfulness
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Providence Care, Kingston, ON, Canada
- Study start
- 30 Oct 2026 (estimated)
- Primary completion
- 20 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 28 Aug 2026 (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.
This pilot clinical trial will study psilocybin-assisted therapy for adults with advanced cancer who are experiencing demoralization, existential distress, or related psychological concerns. Demoralization can include feelings of hopelessness, helplessness, loss of meaning, and distress related to illness or end of life.
The purpose of this study is to assess whether a hybrid group-based psilocybin-assisted therapy program is feasible, acceptable, and safe in adults with advanced cancer. The study will also explore which combination of psilocybin dose and psychotherapy approach may be most promising for a future larger trial.
Participants will be randomly assigned by wave to one of four intervention combinations: 25 mg psilocybin with mindfulness-based psilocybin-assisted therapy, 25 mg psilocybin with standard psilocybin-assisted therapy, 5 mg psilocybin with mindfulness-based psilocybin-assisted therapy, or 5 mg psilocybin with standard psilocybin-assisted therapy. The psilocybin dose will be blinded, meaning participants and some members of the study team will not know which dose was assigned. Psychotherapy approach will not be blinded. The study will enroll at least 60 participants across Calgary and Kingston.
Detailed description
PAT-MIND is a multi-site, phase IIb pilot feasibility and therapy-optimization trial of psilocybin-assisted therapy in adults with advanced cancer. The study uses a wave-randomized 2×2 factorial design to examine two intervention components: psilocybin dose and psychotherapy intensity. Participants will be enrolled in small waves, and each wave will be randomized to one of four combinations: high-dose psilocybin plus mindfulness-based psilocybin-assisted therapy, high-dose psilocybin plus standard psilocybin-assisted therapy, low-dose psilocybin plus mindfulness-based psilocybin-assisted therapy, or low-dose psilocybin plus standard psilocybin-assisted therapy.
The psilocybin dose comparison is blinded. Participants will receive either 25 mg or 5 mg psilocybin during a monitored in-person group dosing session. The psychotherapy intensity comparison is not blinded. Participants will receive either mindfulness-based psilocybin-assisted therapy or standard psilocybin-assisted therapy, depending on their randomized intervention combination. Preparation and integration sessions will be delivered using a hybrid format, with some sessions conducted in person and some virtually, depending on the session type and site logistics.
The primary aims of this pilot trial are to assess the feasibility, acceptability, and safety of hybrid group-based psilocybin-assisted therapy in adults with advanced cancer, and to explore therapy-optimization signals for psilocybin dose and psychotherapy intensity to inform a future definitive trial. Exploratory objectives include participant experience, demoralization, secondary psychological outcomes, health-related quality of life, health-economic measures, and exploratory biomarker outcomes.
Study procedures include screening, informed consent, trial-specific questionnaires, group and individual preparation and integration sessions, a monitored psilocybin dosing day, dried blood spot collection, stool sample collection, optional wearable device data collection, and medical chart review. Participants will complete online questionnaires at protocol-defined timepoints, including measures of demoralization, psychological distress, quality of life, treatment experience, and resource use.
Safety will be monitored throughout the study, including adverse event monitoring during and after the dosing session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Phase IIb pilot feasibility and therapy-optimization trial
| Arm | Type | Receives |
|---|---|---|
| 25 mg Psilocybin + Standard PAT | Experimental | Drug: PEX010 25 mg psilocybin, Behavioral: Standard Psilocybin-Assisted Therapy |
| 25 mg Psilocybin + Mindfulness-Based PAT | Experimental | Drug: PEX010 25 mg psilocybin, Behavioral: Mindfulness-Based Psilocybin-Assisted Therapy |
| 5 mg Psilocybin + Standard PAT | Experimental | Drug: PEX010 5 mg psilocybin, Behavioral: Standard Psilocybin-Assisted Therapy |
| 5 mg Psilocybin + Mindfulness-Based PAT | Experimental | Drug: PEX010 5 mg psilocybin, Behavioral: Mindfulness-Based Psilocybin-Assisted Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Written informed consent provided before any study-specific procedures.
- Age 18 years or older.
- Diagnosis of advanced cancer: Stage III-IV or metastatic solid tumor. Stage II cancer may be eligible if the treating oncologist confirms advanced/refractory disease with clinically significant existential burden, defined as a Demoralization Scale-II (DS-II) score ≥11.
- Clinical life expectancy of at least 6 months. Borderline cases of approximately 5-6 months may be considered based on Principal Investigator judgment and documentation.
- Demoralization Scale-II (DS-II) total score ≥4 at screening, or DS-II total score ≥3 with documented clinical impression of significant existential distress.
Key exclusion criteria (18 listed)
- Active or high-risk suicidality, defined as Columbia-Suicide Severity Rating Scale (C-SSRS) item 4 or 5 within the past 4 weeks, or a suicide attempt within the past 12 months. Passive death wishes and suicidal ideation without intent are not exclusionary.
- Current psychotic disorder or active psychotic symptoms, including schizophrenia, schizoaffective disorder, hallucinations, delusions, or thought disorganization. Historical psychosis in sustained remission may be considered on a case-by-case basis by the Principal Investigator.
- Current manic or mixed-state episode. Stable, euthymic bipolar disorder on maintenance pharmacotherapy may be permitted with Principal Investigator judgment and documentation.
- Moderate-to-severe active alcohol, stimulant, or opioid use disorder within the past 12 months. Severe uncontrolled cannabis use disorder is exclusionary; stable prescribed cannabis use is permitted.
- Use of concomitant medications that does not meet the requirements of the protocol-specified Concomitant Medications Policy.
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 |
|---|---|---|
| PEX010 25 mg psilocybinAlso: Psilocybin, PEX010Participants randomized to this dose condition will receive a single 25 mg oral dose of PEX010 (psilocybin) during a monitored in-person group dosing session, together with protocol-defined psychotherapeutic support | Drug | 25 mg Psilocybin + Mindfulness-Based PAT, 25 mg Psilocybin + Standard PAT |
| PEX010 5 mg psilocybinAlso: Psilocybin, PEX010, low-dose psilocybinParticipants randomized to this dose condition will receive a single 5 mg oral dose of PEX010 (psilocybin) during a monitored in-person group dosing session, together with protocol-defined psychotherapeutic support. This is a blinded low-dose active comparator condition. | Drug | 5 mg Psilocybin + Mindfulness-Based PAT, 5 mg Psilocybin + Standard PAT |
| Standard Psilocybin-Assisted TherapyAlso: Standard PAT, PATParticipants randomized to this psychotherapy condition will receive standard psilocybin-assisted therapy, including protocol-defined preparation, dosing-day support, and integration sessions. The intervention is delivered in a hybrid format, with some sessions conducted in person and some virtually, depending on session type and site logistics. | Behavioural | 25 mg Psilocybin + Standard PAT, 5 mg Psilocybin + Standard PAT |
| Mindfulness-Based Psilocybin-Assisted TherapyAlso: MB-PAT, Mindfulness-Based PATParticipants randomized to this psychotherapy condition will receive mindfulness-based psilocybin-assisted therapy, including protocol-defined preparation, dosing-day support, and integration sessions. The intervention includes mindfulness-based therapeutic elements and is delivered in a hybrid format, with some sessions conducted in person and some virtually, depending on session type and site logistics. | Behavioural | 25 mg Psilocybin + Mindfulness-Based PAT, 5 mg Psilocybin + Mindfulness-Based PAT |
Primary outcome
Overall Trial Feasibility Based on Prespecified RED/YELLOW/GREEN Progression Criteria
Time frame: From initial referral/screening through the 3-month follow-up (A5), up to approximately 4 months
Overall trial feasibility will be assessed using prespecified progression criteria covering recruitment, intervention delivery, and retention. Component metrics include screening completion among referred individuals, eligibility among screened individuals, enrollment among eligible individuals, preparation-session attendance, integration-session attendance, completion of the 1-week post-dose assessment (A3), and completion of the 3-month follow-up (A5). Each component will be expressed as a proportion and classified according to prespecified RED (review), YELLOW (amend), or GREEN (go) thresholds. The overall feasibility classification will be determined by the worst-performing component, resulting in a single overall RED/YELLOW/GREEN progression classification. Feasibility will be assessed pooled across all four intervention arms.
Incidence of Adverse Events (AEs)
Time frame: From informed consent through the 3-month follow-up (A5), approximately up to 4 months
Safety will be assessed in all participants who receive psilocybin. Adverse events will be collected from informed consent through the 3-month follow-up (A5) and summarized as the number and proportion of participants experiencing one or more adverse events. Events will be characterized by severity, relationship to psilocybin, dose group, and timing. Serious adverse events (SAEs) and protocol-defined adverse events of special interest (AESIs) will be identified and summarized as prespecified safety categories.
9 secondary outcomes
Change in Demoralization Scale-II (DS-II) Total Score
Time frame: Baseline to 1 week post-dose
Change in anxiety symptoms assessed by PROMIS Anxiety Short Form 8a
Time frame: Baseline through 3 months post-dose
Change in depressive symptoms assessed by PROMIS Depression Short Form 8a
Time frame: Baseline through 3 months post-dose
Change in Death and Dying Distress Scale (DADDS) Total Score
Time frame: Baseline through 3 months post-dose
Change in Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being 12-Item Scale (FACIT-Sp-12) Score
Time frame: Baseline through 3 months post-dose
Change in PROMIS Pain Intensity Score
Time frame: Baseline through 3 months post-dose
Change in PROMIS Pain Interference Score
Time frame: Baseline through 3 months post-dose
Change in EuroQol Five-Dimension Five-Level (EQ-5D-5L) Health Utility Score
Time frame: Baseline through 3 months post-dose
Change in Mindfulness Assessed by the Mindful Allowance 8-Item Short Form
Time frame: Baseline through 3 months post-dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. A final decision regarding sharing of de-identified individual participant data has not yet been made. Any future data sharing will be subject to participant consent, research ethics approval, applicable privacy legislation, institutional requirements, and approval by the Trial Steering Committee.
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A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
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.
Chantal Savard, BA contact
Linda E. Carlson, Ph.D., R.Psych, FCAHS, FABMR principal investigator
University of Calgary
Ron Shore, MPA, PhD principal investigator
Queen's University
Harriet Richardson, MSc, PhD principal investigator
Queen's University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PEX010 25 mg psilocybin, PEX010 5 mg psilocybin and Standard Psilocybin-Assisted Therapy in people with Advanced Cancer and Demoralization, run by University of Calgary at 2 sites in Canada.
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 9 inclusion and 18 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: opening soon, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christopher P. Albertyn, PhD (587-231-3984, christopher.albertyn@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Trial Feasibility Based on Prespecified RED/YELLOW/GREEN Progression Criteria (time frame: From initial referral/screening through the 3-month follow-up (A5), up to approximately 4 months). The study lists 2 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 2 Sep 2026.