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

Status
Active
Cancer Type
Hematopoietic Malignancies
Solid Tumor
Trial Phase
Phase I
Eligibility
26 - 85 Years, Male and Female
Study Type
Supportive care
NCT ID
NCT05506982
Protocol IDs
EU5206-20 (primary)
NCI-2020-13913
STUDY00001905
Study Sponsor
Emory University Hospital/Winship Cancer Institute

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.

Eligibility

  1. Signed informed consent form (ICF)
  2. Diagnosis of solid or liquid cancer made >= 1 year at any stage in cancer survivorship (specifically, active cancer treatment or no cancer-directed therapy either in clinical remission or with advanced disease)
  3. Prognosis of greater than six months as determined by their primary oncologist
  4. Moderate-to-severe demoralization (score of >= 10 on the Demoralization Scale-II [DS-II])
  5. Chronic pain (pain lasting > 3 months) per patient report and score of >= 5 for average pain level on Brief Pain Inventory
  6. Age >= 26 years old and =< 85 years old
  7. Availability of a caregiver to complete caregiver-related assessments
  8. Availability of a friend or family member into whose care the participant can be released following the drug administration session

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.
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Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.