Clinical TrialPalliative & End-of-Life DistressPsilocybinCompleted

Psilocybin-Assisted Therapy for the Treatment of Cancer-Related Anxiety in Patients With Metastatic Cancer

Phase I/II single-group trial (n=55 actual) of oral psilocybin plus group and individual therapy for anxiety and/or depression in patients with metastatic cancer to assess safety and side effects.

Target Enrollment
55 participants
Study Type
Phase I/II interventional
Design
Non-randomized

Detailed Description

This Phase I/II single-group treatment study evaluates pharmaceutical-grade oral psilocybin administered alongside group and individual psychotherapy for patients with metastatic cancer experiencing clinically significant anxiety and/or depressive symptoms.

Primary outcomes focus on safety and adverse events; secondary assessments include anxiety and depression measures. Eligible participants must be medically stable, off contraindicated psychotropic medications, and able to participate in group therapy.

Psilocybin used is a pharmaceutical-grade formulation (CY-39/Indocybin) given orally with preparatory and integration sessions.

Study Protocol

Preparation

sessions

Dosing

sessions

Integration

sessions

Therapeutic Protocol

support

Study Arms & Interventions

Psilocybin + therapy

experimental

Single-group treatment: oral psilocybin administered with group and individual therapy sessions.

Interventions

  • Psilocybin
    via Oral• single dose

    Pharmaceutical-grade psilocybin (CY-39/Indocybin) administered orally; paired with group and individual counselling/therapy.

Participants

Ages
18 – 85
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • A diagnosis of metastatic solid tumor, or incurable hematologic malignancy documented by a physician
  • Measurable disease is not required
  • No minimum or maximum prior lines of chemotherapy required
  • 18-85 years of age
  • ECOG performance status 0-2
  • Hematocrit > 20
  • Platelets (Plt) > 20K
  • Liver function tests ≤ 1.5 x normal
  • Creatinine ≤ 1.5 x normal
  • Subjects of childbearing potential must agree to effective contraception from enrollment until at least 1 month after dosing
  • At least 4 weeks post-surgery or radiotherapy at entry; may receive chemo if scheduling can accommodate medication session
  • Motivated and able to participate effectively in a small group per investigator judgment
  • Clinically significant anxiety or depressive symptoms on pre-enrolment screening (HADS-Total ≥ 11)
  • English speaking and able to give written informed consent
  • Willing to sign medical release for study investigators to communicate with treating clinicians
  • Must provide at least one adult contact able to monitor and report behavioural changes
  • Off SSRIs for five half-lives plus 2 weeks prior to dosing
  • Must avoid initiating psychiatric medications during study; prn benzodiazepines allowed with PI review for high-dose chronic use; prn gabapentinoids allowed with PI review for high-dose chronic use
  • Willing to attend preparation, dosing, and integration sessions and complete study assessments and calls

Exclusion Criteria

  • Exclusion Criteria:
  • Untreated brain metastases
  • Uncontrolled or concurrent illness (e.g., active infection, symptomatic CHF, unstable angina, cardiac arrhythmia) or psychiatric/social situations limiting compliance
  • Pregnancy, breastfeeding, or intent to conceive/impregnate through 30 days after dosing
  • Personal or immediate family history of schizophrenia, bipolar disorder, delusional/paranoid disorders, or schizoaffective disorder
  • Suicidal ideation with a Columbia-Suicidality Severity Rating Scale (C-SSRS) score ≥ 3
  • Current substance use disorder (reasonable alcohol or marijuana use not meeting SUD may be allowed)
  • Use of neuroleptics or SSRIs that cannot be tapered (ondansetron allowed for nausea)
  • Unstable neurological/medical conditions; history of seizures or chronic/severe headaches
  • High-dose psychedelic use within prior 12 months (psilocybin >2 g dried mushrooms, LSD >200 µg); microdosing allowed but must stop 1 month before entry
  • Use of tramadol (risk of serotonin syndrome)
  • Use of MAOIs or known sensitivity to psilocybin/metabolites; concomitant SSRI/SNRI generally contraindicated
  • Marked baseline QTc prolongation (e.g., QTc > 450 ms) or other torsade risk factors
  • Concomitant medications that prolong QT/QTc interval

Study Details

Locations

Fred Hutch/University of Washington Cancer Consortium — Seattle, Washington, United States

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