Clinical TrialPalliative & End-of-Life DistressPsilocybinKetamineRecruiting

Pragmatic Trial of Psilocybin Therapy in Palliative Care (PT2PC)

Multicenter, quadruple-blind, Phase II randomized controlled trial (n=100) comparing a single oral dose of psilocybin plus brief existential psychotherapy versus a single oral dose of ketamine plus the same psychotherapy for demoralization in patients near end of life (≤2 years expected).

Target Enrollment
100 participants
Study Type
Phase II interventional
Design
Randomized, quadruple Blind

Detailed Description

Parallel-group randomized trial assigning participants to one single oral dose of psilocybin plus 4–5 sessions of brief existential psychotherapy or to one single oral dose of oral ketamine plus the same psychotherapy; control arm may optionally crossover.

Primary outcomes assess change in demoralization; secondary measures include depression and anxiety at 1, 2 and 5 weeks post-dosing. After study completion participants may be unblinded and those assigned to the active control are offered psilocybin plus psychotherapy.

Population: adults with life-threatening illness receiving care at participating sites with expected survival ≤2 years and moderate-to-severe demoralization; ability to take oral medication required.

Study Protocol

Preparation

4 sessions

Dosing

1 sessions

Integration

1 sessions

Therapeutic Protocol

existential humanistic

Study Arms & Interventions

Psilocybin

experimental

Single oral psilocybin dose plus 4–5 sessions of brief existential psychotherapy; parallel design with optional crossover for control arm.

Interventions

  • Psilocybin
    via Oral• single dose• 1 doses total

    Dose not specified in registry record.

Ketamine

active comparator

Single oral ketamine dose (active control) plus 4–5 sessions of brief existential psychotherapy; optional crossover for control arm.

Interventions

  • Ketamine
    via Oral• single dose• 1 doses total

    Oral liquid ketamine; dose not specified in registry record.

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • General
  • Provision of signed and dated informed consent form and the capacity to consent to research.
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Is currently a patient in a study-engaged clinical site
  • Has a life-threatening illness and a life expectancy of ≤2 years
  • Has moderate-to-severe demoralization
  • Ability to take oral medication (capsules and liquid)

Exclusion Criteria

  • Exclusion Criteria:
  • General
  • Known allergic or severe reactions to the non-psychoactive components of psilocybin capsules or liquid ketamine
  • Treatment with another investigational drug or intervention within 1 month of signing Informed Consent Form (ICF)
  • If deemed by clinical judgment of the study investigators to be unsafe for undergoing the intervention
  • Neurological
  • Cognitive impairment sufficient to impede the ability to complete study tasks
  • History of intracranial hemorrhage
  • Recent embolic stroke
  • Recent seizure
  • Current intracranial mass
  • Advanced stage of a neurologic disease that elevates risk for psychosis
  • Cardiovascular
  • Uncontrolled hypertension
  • Clinically significant cardiac disease
  • Respiratory
  • Severe pulmonary disease
  • Supplemental oxygen requirement
  • Gastrointestinal
  • Current intractable nausea/vomiting/diarrhea
  • Recent, clinically significant GI bleed
  • Markedly abnormal liver function tests
  • Endocrine, Renal, and Reproductive
  • Pregnancy or lactation
  • Severe renal insufficiency
  • Unstable insulin-dependent diabetes mellitus
  • Prohibited Medications
  • Antipsychotics (with exceptions)
  • Antidepressants (with exceptions)
  • Dopamine agonists
  • Drugs known to have adverse interactions with psilocybin or ketamine

Study Details

Locations

Marin Cancer Care — Greenbrae, California, United States
University of California, Los Angeles — Los Angeles, California, United States
University of San Francisco — San Francisco, California, United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center — Torrance, California, United States
Sunstone Therapies — Rockville, Maryland, United States

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