Psilocybin With Psychotherapy for Improving Chronic Pain in Cancer Patients Requiring Opioids

Part of paid clinical trials in Buffalo, New York.

Sponsor
Roswell Park Cancer Institute
Study ID
NCT06827054
Phase
PHASE2
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Hematopoietic and Lymphatic System Neoplasm
  • Malignant Solid Neoplasm

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood and urine samples
  • Functional Magnetic Resonance Imaging — PROCEDURE
    Undergo fMRI
  • Interview — OTHER
    Ancillary studies
  • Psilocybine — DRUG
    Given PO
  • Psychotherapy — BEHAVIORAL
    Attend psychotherapy sessions
  • Questionnaire Administration — OTHER
    Ancillary studies

Study Details

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.

Key Dates

Start date
May 15, 2026
Status verified
Mar 2026
Primary completion
May 5, 2027
Completion
May 5, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Supportive care (psychotherapy, psilocybin)
    Patients attend two preparatory psychotherapy sessions. Patients then receive psilocybin PO BIW for 4 weeks (8 doses total) in the absence of unacceptable toxicity and attend three integration psychotherapy sessions over 1.5 hours each during psilocybin dosing sessions 2, 4, and 6. Patients may optionally attend additional psychotherapy sessions as needed during follow-up. Additionally, patients undergo fMRI and collection of blood and urine samples throughout the study.

Primary Outcome Measure

Incidence of adverse events (AEs) [ Time Frame: From start date of intervention to 30 days after the last intervention ]

Locations (1)

FacilityCityStateZIPSite coordinators
Roswell Park Cancer InstituteBuffaloNew York14263
William Alexander
[email protected]
716-845-1479
William Alexander (PRINCIPAL_INVESTIGATOR)

Find similar trials in Buffalo, NY

By research site
Roswell Park Cancer Institute· Buffalo, NY

Related Studies