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

NCT05506982 | Completed Phase 1 DMC FDA Drug

• 4 other identifiers: STUDY00001905NCI-2020-13913EU5206-20P30CA138292
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (2)

• Incidence Of Treatment-Related Medical Grade 3 Or Higher Or Psychiatric Grade 4 Or Higher

  Adverse events are graded according to Common Terminology Criteria for Adverse Events. Descriptive statistics will summarize the incidence and duration of adverse events, with the primary outcome of interest being the incidence of medical Grade 3 or higher or psychiatric Grade 4 or higher Common Terminology Criteria for Adverse Events considered by the PI to be treatment-related occurring by day 42. These events will be evaluated by adverse events, vital signs, ECG, and laboratory findings. A successful outcome is no medical or psychiatric Grade 4 adverse events or higher.

  Up to 42 days

• Evaluation of Feasibility Outcome To Assess Patient Retention in The Study

  Feasibility will be assessed by patient retention in the study, number of missed events, a survey assessing acceptability of the protocol at study endpoint, and fidelity to the intervention elements. A successful outcome is retention of 80% of subjects enrolled in the study, 80% of events attended by subjects, and 60% of subjects find intervention satisfactory.

  Up to 42 days

Other Outcomes (24)

• Evaluate for Changes in Demoralization at Forty-Two Days

  At 42 days

• Evaluate for Changes in Demoralization at Ninety-Eight Days

  At 98 days

• Impact of Pain Intensity and Interference with Daily Functioning at Forty-Two Days

  At 42 days

Study Arms (1)

Supportive care (psilocybin, observation)

EXPERIMENTAL

Patients receive psilocybin PO and undergo observation for up to 24 hours on day 14.

Drug: Psilocybin; Behavioral: Psychotherapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Psilocybin DRUG

Given PO

Also known as: CY-39, Indocybin

Supportive care (psilocybin, observation)

Psychotherapy BEHAVIORAL

supportive care

Also known as: talk therapy

Supportive care (psilocybin, observation)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Supportive care (psilocybin, observation)

Questionnaire Administration OTHER

Ancillary studies

Supportive care (psilocybin, observation)

Eligibility Criteria

• Age: 26 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent form (ICF)
• 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)
• Prognosis of greater than six months as determined by their primary oncologist
• Moderate-to-severe demoralization (score of \>= 10 on the Demoralization Scale-II \[DS-II\])
• Chronic pain (pain lasting \> 3 months) per patient report and score of \>= 5 for average pain level on Brief Pain Inventory
• Age \>= 26 years old and ≤85 years old
• Availability of a friend or family member into whose care the participant can be released following the drug administration session

You may not qualify if:

• Pregnancy or breastfeeding
• Women of childbearing potential (i.e., not permanently sterilized, not postmenopausal) who decline to use a highly effective dual contraceptive method for the duration of the study. Dual contraceptive method use is defined by a use a barrier contraceptive in addition to another method to prevent pregnancy, including sterilization, hormonal methods, intrauterine devices, and hormonal pills.
• Age \< 26 years old and \> 85 years old
• Poor functional status (Eastern Cooperative Oncology Group \[ECOG\] score of \>= 2)
• Major cognitive impairment as determined by principal investigator
• Non-fluency in the English language
• Personal history of a psychotic disorder or Bipolar disorder type I/II
• Active suicidal ideation with intent in the last 3 months (Columbia Suicide Severity Rating Scale suicidal ideation score \> 3) or any suicide attempt in the past year
• Current substance use disorder (i.e., present in last six months), of greater than mild severity as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM-V)
• History of a seizure disorder in adulthood
• Active central nervous system (CNS) metastases or symptomatic CNS infection
• Uncontrolled hypertension (mean blood pressure (mmHg) exceeding 139 systolic and 89 diastolic) and heart rate exceeding 90 beats per minute
• Clinically significant cardiovascular disease (coronary artery disease, congestive heart failure, arrhythmia, or QTc\>450ms)
• Supplemental oxygen requirement
• Body mass index =\< 18

Sponsors & Collaborators

• Emory University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Emory University/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

Brain Health Center at Executive Park

Atlanta, Georgia, 30329, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Psilocybin; Psychotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines; Behavioral Disciplines and Activities

Study Officials

• Ali J. Zarrabi, MD

  Emory University Hospital/Winship Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 6, 2022
• First Posted: August 18, 2022
• Study Start: November 1, 2022
• Primary Completion: April 25, 2024
• Study Completion: January 24, 2025
• Last Updated: July 23, 2025

Record last verified: 2025-07

Locations

US (2)