MB-PAT for Demoralization in Advanced Cancer ('PAT-MIND') Trial

NCT07791901 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: HREBA.CC-24-0258
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Advanced Cancer; Demoralization; Existential Distress; Psychological Distress

Keywords

psychedelics; psilocybin; cancer; demoralization; late-stage; psychedelic-assisted therapy; PAT; Mindfulness; existential distress

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  Baseline to 1 week post-dose

• Change in anxiety symptoms assessed by PROMIS Anxiety Short Form 8a

  Baseline through 3 months post-dose

• Change in depressive symptoms assessed by PROMIS Depression Short Form 8a

  Baseline through 3 months post-dose

• Change in Death and Dying Distress Scale (DADDS) Total Score

  Baseline through 3 months post-dose

• Change in Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being 12-Item Scale (FACIT-Sp-12) Score

  Baseline through 3 months post-dose

Study Arms (4)

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

Interventions

PEX010 25 mg psilocybin DRUG

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

Also known as: Psilocybin, PEX010

25 mg Psilocybin + Mindfulness-Based PAT; 25 mg Psilocybin + Standard PAT

PEX010 5 mg psilocybin DRUG

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.

Also known as: Psilocybin, PEX010, low-dose psilocybin

5 mg Psilocybin + Mindfulness-Based PAT; 5 mg Psilocybin + Standard PAT

Standard Psilocybin-Assisted Therapy BEHAVIORAL

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.

Also known as: Standard PAT, PAT

25 mg Psilocybin + Standard PAT; 5 mg Psilocybin + Standard PAT

Mindfulness-Based Psilocybin-Assisted Therapy BEHAVIORAL

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.

Also known as: MB-PAT, Mindfulness-Based PAT

25 mg Psilocybin + Mindfulness-Based PAT; 5 mg Psilocybin + Mindfulness-Based PAT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• Psychiatric/Psychological:
• 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.
• Pharmacological/Drug Interactions:
• 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.

Sponsors & Collaborators

• University of Calgary: lead
• Providence Care, Kingston, ON, Canada: collaborator

Study Sites (2)

Arthur Child Comprehensive Cancer Centre

Calgary, Alberta, T2N 4N1, Canada

Location

Providence Care Hospital

Kingston, Ontario, K7L 4X3, Canada

Location

Related Links

• Related Info

MeSH Terms

Conditions

Neoplasms

Interventions

Psilocybin

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines

Study Officials

• Linda E. Carlson, Ph.D., R.Psych, FCAHS, FABMR

  University of Calgary

  PRINCIPAL INVESTIGATOR

• Ron Shore, MPA, PhD

  Queen's University

  PRINCIPAL INVESTIGATOR

• Harriet Richardson, MSc, PhD

  Queen's University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher P. Albertyn, PhD

CONTACT

587-231-3984; christopher.albertyn@ucalgary.ca

Chantal Savard, BA

CONTACT

chantal.savard1@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Phase IIb pilot feasibility and therapy-optimization trial

Study Record Dates

• First Submitted: August 6, 2026
• First Posted: August 28, 2026
• Study Start (Estimated): October 30, 2026
• Primary Completion (Estimated): December 20, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 28, 2026

Record last verified: 2026-08

Locations

CA (2)