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.
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Incidence of adverse events (AEs)
Timeframe: From start date of intervention to 30 days after the last intervention
Change in Vital signs
Timeframe: Up to baseline, dosing sessions 1 and 2 up to day 84
Incidence of clinically important changes in ICG parameters
Timeframe: At baseline and day 28
Change in risk for suicide
Timeframe: At baseline, dosing sessions 1, 2, 3, 5, and 7, and days 28, 56, and 84
Change in cognitive function
Timeframe: At dosing sessions 1-3 and days 28, 56, and 84
Recruitment rate
Timeframe: Up to day 84
Retention rate
Timeframe: Up to day 84