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

Active:	Yes
Cancer Type:	Hematopoietic Malignancies Solid Tumor	NCT ID:	NCT05506982
Trial Phases:	Phase I	Protocol IDs:	EU5206-20 (primary) NCI-2020-13913 STUDY00001905
Eligibility:	26 - 85 Years, Male and Female	Study Type:	Supportive care
Study Sponsor:	Emory University Hospital/Winship Cancer Institute
NCI Full Details:	http://clinicaltrials.gov/show/NCT05506982

Summary

This phase I trial evaluates the side effects of psilocybin and how well it works under supportive care conditions in cancer survivors living with demoralization and chronic pain. Cancer patients often experience demoralization, which is characterized by feelings of hopelessness, loss of meaning, and existential distress. Psilocybin psychotherapy, together with supportive care, may help treat the anxiety, depression, and chronic pain felt by cancer survivors.

Objectives

PRIMARY OBJECTIVE:
I. To determine the safety, feasibility, and acceptability of a single administration of 25 mg psilocybine (psilocybin) provided under supportive conditions with multidisciplinary palliative care support (P-PC) in adult cancer survivors living with concurrent demoralization and chronic pain.

EXPLORATORY OBJECTIVE:
I. To evaluate for changes in demoralization, anxiety, depression, quality of life, pain, other symptoms, mysticism, awe, post-traumatic growth, social isolation, and psychosocial functioning from baseline to end-of-treatment to 3.5-month follow up.
II. To solicit qualitative information for facilitators and subjects for the tailoring and improvement of the behavioral components of the intervention

OUTLINE:
Patients receive psilocybin orally (PO) and undergo observation for up to 24 hours on day 14.

After completion of study intervention, patients are followed up on days 15, 21, 42, 56, and 98.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.