Clinical TrialPalliative & End-of-Life DistressPsilocybinCompleted

Pilot Study of Psilocybin-Assisted Therapy for Demoralization in Patients Receiving Hospice Care

Feasibility, single-group psilocybin-assisted psychotherapy pilot (n≈15) delivering one 25 mg oral psilocybin session with preparatory and integration therapy for demoralization in hospice patients.

Target Enrollment
15 participants
Study Type
Phase II interventional
Design
Non-randomized

Detailed Description

This feasibility study evaluates a single 25 mg oral psilocybin administration combined with supportive psychotherapy (two preparation sessions and two integration sessions) for demoralization in patients receiving hospice care.

Primary aims are to assess safety and tolerability in a terminally ill population and to gather preliminary data on reductions in psychological and existential distress over a 24-week follow-up.

Approximately 15 participants will be enrolled; key assessments include demoralization scores, safety labs, and monitoring for suicidal ideation and adverse events.

Study Protocol

Preparation

2 sessions

Dosing

1 sessions

Integration

2 sessions

Therapeutic Protocol

support

Study Arms & Interventions

PATH

experimental

Single-group PATH intervention: single oral psilocybin administration (25 mg) with supportive psychotherapy (2 preparation sessions, 2 integration sessions).

Interventions

  • Psilocybin25 mg
    via Oral• single dose• 1 doses total

    Single 25 mg oral psilocybin dose.

  • Compound
    • supportive psychotherapy

    Two preparation sessions and two integration sessions paired with dosing; behavioural therapy component.

Participants

Ages
21 – 88
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Patients enrolled in hospice care at home
  • Age ≥ 21 years
  • Any terminal illness subject to exclusion criteria
  • Palliative Performance Scale (PPS) ≥ 50%
  • Moderate-to-severe demoralization (Demoralization Scale-II ≥ 8)
  • Significant other or caregiver present at home the night of study drug administration
  • No driving for 24 hours following study drug administration
  • English proficiency
  • Ability and willingness to sign written informed consent
  • Agreement to use acceptable contraception if of child-bearing potential (duration: participation + 4 months post-dose)

Exclusion Criteria

  • Exclusion Criteria:
  • Current General Inpatient (GIP) hospice status
  • Currently receiving chemotherapy
  • Condition impairing oral intake or absorption
  • Delirium diagnosed by CAM
  • Significant suicide risk (suicidal ideation with intent and plan within past month or at V0)
  • Current or past history of schizophrenia, psychotic disorder, bipolar disorder, delusional disorder, paranoid personality disorder, schizoaffective disorder, or borderline personality disorder
  • First-degree relatives with schizophrenia or bipolar disorder
  • History of allergic reactions to compounds similar to psilocybin
  • Other personal circumstances limiting compliance or safety judged by PI/psychiatrist
  • Concomitant medications with significant interaction potential that cannot be tapered (e.g., serotonergic antidepressants, MAO inhibitors, antipsychotics, lithium, valproic acid, disulfiram, significant UGT1A0/1A10 inhibitors)
  • End-stage liver disease or cirrhosis as primary hospice diagnosis
  • AST/ALT ≥5× upper limit or symptoms suggestive of liver failure
  • Any other clinically significant unstable cardiovascular, pulmonary, gastrointestinal, hepatic, renal, or other condition placing participant at risk or interfering with interpretation of results
  • Pregnant, nursing, or planning pregnancy

Study Details

Locations

Care Dimensions — Danvers, Massachusetts, United States

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