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

Malignant Solid Neoplasm Clinical Trial

Official title:
The Safety, Feasibility, and Acceptability of Psilocybin Combined With Multidisciplinary Palliative Care in Demoralized Cancer Survivors With Chronic Pain (P-PC)

Clinical Trial 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 multidisciplinary palliative and supportive care, may help treat the anxiety, depression, and chronic pain felt by cancer survivors - defined here as cancer patients from time of diagnosis through the end-of-life.

Clinical Trial Description

PRIMARY OBJECTIVE: I. To determine the safety, feasibility, and acceptability of a single administration of 25 mg psilocybin (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. OUTLINE: Patients receive psilocybin orally (PO) and undergo observation for up to 8 hours on day 14. After completion of study intervention, patients are followed up on days 15, 21, 42, 56, and 98. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05506982
Study type Interventional
Source Emory University
Contact
Status Active, not recruiting
Phase Phase 1
Start date November 1, 2022
Completion date August 31, 2024
View Details
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