About this trial

This phase II trial studies whether psilocybin with psychotherapy is safe and if it works for improving chronic pain in cancer patients who require opioids to manage their pain. Psilocybin is taken from the mushroom Psilocybe mexicana. Psilocybin acts on the brain to cause hallucinations (sights, sounds, smells, tastes, or touches that a person believes to be real but are not real). This may impact a patient's "total pain", a view that accounts for the psychological, spiritual, and social factors that contribute to their experience of pain. Psychotherapy uses methods such as discussion, listening, and counseling to help patients change the way they react to environmental triggers that may cause a negative reaction. Giving psilocybin with psychotherapy may be safe and helpful for improving chronic pain in cancer patients who require opioids to manage their pain.

Eligibility criteria

Qualifiers

Age ≥ 18 and ≤ 75 years old

Diagnosis of active cancer, any stage

Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

Estimated prognosis of ≥ 3 months at the time of enrollment, determined by participant's primary oncologist or palliative physician

Disqualifiers

Participants who are pregnant or breast-feeding

Participants of childbearing potential who decline to use a highly effective dual contraceptive method for the duration of the study

Participants with a condition impairing oral intake or digestive absorption

Cognitive impairment as defined by Montreal Cognitive Assessment (MOCA) score < 23

Trial design

Treatments tested in this trial

  • Biospecimen Collection
  • Functional Magnetic Resonance Imaging
  • Interview
  • Psilocybine
  • Psychotherapy
  • Questionnaire Administration

Treatment groups

20 Participants
are divided into 1 treatment group

Locations

1
Roswell Park Cancer Institute14263, BuffaloNew York, United States

Sponsors and collaborators

Roswell Park Cancer Institute

Lead sponsor