Roswell Park Cancer Institute
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.
PRIMARY OBJECTIVE: I. To evaluate the safety, tolerability, and feasibility of low dose psilocybin therapy in patients with chronic cancer pain who require opioids. SECONDARY OBJECTIVE: I. To obtain preliminary evidence for efficacy of low dose psilocybin therapy in reducing pain and opioid requirement in participants with chronic cancer pain. EXPLORATORY OBJECTIVES: I. To evaluate potential mechanisms of action for psilocybin in pain control, including its effects on resting brain network activity, inflammation, and psychological changes processes. II. To obtain preliminary evidence for…
Inclusion Criteria: * 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 * Diagnosis of moderate to severe pain (reported average pain score ≥ 4 on the 11-point Numerical Rating Scale) that is chronic (≥ 3 months) and secondary to cancer or cancer treatment * Pain regimen has been escalated to opioid therapy * Participants must be on stable pain regi…
Undergo collection of blood and urine samples
Undergo fMRI
Ancillary studies
Given PO
Attend psychotherapy sessions
Ancillary studies
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