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

Sponsor
University of Calgary
Study ID
NCT07791901
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Advanced Cancer
  • Demoralization
  • Existential Distress
  • Psychological Distress

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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
  • 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.
  • 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.
  • 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.

Study Details

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.

Key Dates

First listed
Aug 28, 2026
Start date
Oct 30, 2026
Status verified
Aug 2026
Primary completion
Dec 20, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Experimental: 25 mg Psilocybin + Standard PAT
  • Experimental: 25 mg Psilocybin + Mindfulness-Based PAT
  • Experimental: 5 mg Psilocybin + Standard PAT
  • Experimental: 5 mg Psilocybin + Mindfulness-Based PAT

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 ]

Central Contacts

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