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

Interventions

DRUG

PEX010 25 mg psilocybin

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

DRUG

PEX010 5 mg 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.

BEHAVIORAL

Standard Psilocybin-Assisted Therapy

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.

BEHAVIORAL

Mindfulness-Based Psilocybin-Assisted Therapy

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.

Sponsors & Collaborators

• Providence Care, Kingston, ON, Canada

  collaborator UNKNOWN

• University of Calgary

  lead OTHER

Principal Investigators

• Linda E. Carlson, Ph.D., R.Psych, FCAHS, FABMR · University of Calgary

• Ron Shore, MPA, PhD · Queen's University

• Harriet Richardson, MSc, PhD · Queen's University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-10-30

Primary Completion

2027-12-20

Completion

2027-12-31

Countries

• Canada

Study Locations