Clinical TrialPalliative & End-of-Life DistressPsilocybinCompleted

Psilocybin Combined With Multidisciplinary Palliative Care in Demoralized Cancer Survivors With Chronic Pain

Open-label, single-group Phase I study (n≈11) assessing safety, feasibility, and acceptability of a single 25 mg oral psilocybin dose with supportive psychotherapy and multidisciplinary palliative care in cancer survivors with demoralization and chronic pain.

Target Enrollment
11 participants
Study Type
Phase I interventional
Design
Non-randomized

Detailed Description

This Phase I single-group study evaluates safety, feasibility, and acceptability of a single 25 mg oral psilocybin administration provided with supportive psychotherapy and multidisciplinary palliative care in adult cancer survivors living with demoralization and chronic pain; participants are observed after dosing and followed to 3.5 months.

Exploratory outcomes include changes in demoralization, anxiety, depression, quality of life, pain, mysticism, post-traumatic growth, social isolation, and psychosocial functioning; assessments occur across multiple post-dose visits.

Study Protocol

Preparation

sessions

Dosing

1 sessions
480 min each

Integration

sessions

Therapeutic Protocol

support

Study Arms & Interventions

Psilocybin + supportive care

experimental

Single-group administration of psilocybin with supportive psychotherapy and multidisciplinary palliative care; observation and scheduled follow-ups.

Interventions

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

    Single oral dose administered on day 14 with post-dose observation.

  • Compound

    Supportive psychotherapy provided alongside dosing and follow-up visits.

  • Compound

    Quality-of-life assessments and questionnaire administration as ancillary measures.

Participants

Ages
26 – 85
Sexes
Male & Female

Inclusion Criteria

  • Signed informed consent form (ICF)
  • Diagnosis of solid or liquid cancer made >= 1 year at any stage in cancer survivorship (active treatment or in remission or advanced disease)
  • Prognosis of greater than six months as determined by their primary oncologist
  • Moderate-to-severe demoralization (score of >= 10 on the Demoralization Scale-II [DS-II])
  • Chronic pain (pain lasting > 3 months) per patient report and score of >= 5 for average pain level on Brief Pain Inventory
  • Age >= 26 years old and <=85 years old
  • Availability of a friend or family member into whose care the participant can be released following the drug administration session

Exclusion Criteria

  • Pregnancy or breastfeeding
  • Women of childbearing potential who decline to use a highly effective dual contraceptive method for the duration of the study
  • Poor functional status (ECOG score >= 2)
  • Major cognitive impairment as determined by principal investigator
  • Non-fluency in the English language
  • Personal history of a psychotic disorder or Bipolar disorder type I/II
  • Active suicidal ideation with intent in the last 3 months (C-SSRS suicidal ideation score > 3) or any suicide attempt in the past year
  • Current substance use disorder of greater than mild severity (within last six months)
  • History of a seizure disorder in adulthood
  • Active CNS metastases or symptomatic CNS infection
  • Uncontrolled hypertension (mean BP >139/89 mmHg) and heart rate >90 bpm
  • Clinically significant cardiovascular disease (coronary artery disease, CHF, arrhythmia, or QTc >450 ms)
  • Supplemental oxygen requirement
  • Body mass index =< 18
  • Renal insufficiency (CrCl < 30 mL/min)
  • Concomitant use of drugs known to interact with psilocybin (probenecid, diclofenac)
  • Consistent use of serotonergic drugs (SSRIs, SNRIs, efavirenz) or MAOIs; other antidepressant/stimulant/antipsychotic meds may be tapered under supervision prior to baseline
  • Considered by PI to be inappropriate for safety or unlikely to complete protocol

Study Details

Locations

Emory University/Winship Cancer Institute — Atlanta, Georgia, United States
Brain Health Center at Executive Park — Atlanta, Georgia, United States

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