Supportive care (psilocybin, observation) for Malignant Solid Neoplasms

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Emory University/Winship Cancer Institute, Atlanta, GA
Malignant Solid Neoplasms+3 More
Psilocybine - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions

  • Malignant Solid Neoplasms
  • Hematopoietic and Lymphoid Cell Neoplasm

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Malignant Solid Neoplasms

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: At 98 days

At 42 days
Anxiety and Depression at Forty-Two Days
Caregiver strain at Forty-Two Days
Evaluate for Changes in Demoralization at Forty-Two Days
Global Symptom Burden at Forty-Two Days
Global psychosocial functioning (participant and caregiver) at Forty-Two Days
Impact of Pain Intensity and Interference with Daily Functioning at Forty-Two Days
Impact of pain intensity and interference with catastrophizing through rumination, helplessness, and pessimism at Forty-Two Days
Quality of Life Assessment at Forty-Two Days
Religious and spiritual assessment at Forty-Two Days
Self-reported opioid use in the form of oral morphine equivalents over past week at Forty-Two Days
Self-reported polypharmacy over past week at Forty-Two Days
Social connectedness at Forty-Two Days
At 98 days
Anxiety and Depression at Ninety-Eight Days
Caregiver strain at Ninety-Eight Days
Evaluate for Changes in Demoralization at Ninety-Eight Days
Global Symptom Burden at Ninety-Eight Days
Global psychosocial functioning (participant and caregiver) at Ninety-Eight Days
Impact of Pain Intensity and Interference with Daily Functioning at Ninety-Eight Days
Impact of pain intensity and interference with catastrophizing through rumination, helplessness, and pessimism at Ninety-Eight Days
Quality of Life Assessment at Ninety-Eight Days
Religious and spiritual assessment at Ninety-Eight Days
Self-reported opioid use in the form of oral morphine equivalents over past week at Ninety-Eight Days
Self-reported polypharmacy over past week
Social connectedness at Ninety-Eight Days
Up to 42 days
Evaluation of Feasibility Outcome To Assess Patient Retention in The Study
Incidence Of Treatment-Related Medical Grade 3 Or Higher Or Psychiatric Grade 4 Or Higher

Trial Safety

Safety Progress

1 of 3

Other trials for Malignant Solid Neoplasms

Trial Design

1 Treatment Group

Supportive care (psilocybin, observation)
1 of 1
Experimental Treatment

10 Total Participants · 1 Treatment Group

Primary Treatment: Supportive care (psilocybin, observation) · No Placebo Group · Phase 1

Supportive care (psilocybin, observation)Experimental Group · 5 Interventions: Psilocybine, Psilocybin, Quality-of-Life Assessment, Psychotherapy, Questionnaire Administration · Intervention Types: Drug, Drug, Other, Behavioral, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybine
2013
N/A
~140
Psilocybin
2018
Completed Phase 2
~590
Psychotherapy
2008
Completed Phase 3
~2640

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at 98 days

Trial Background

Ali Zarrabi, Principal Investigator
Principal Investigator
Emory University
Closest Location: Emory University/Winship Cancer Institute · Atlanta, GA
Photo of Atlanta  1Photo of Atlanta  2Photo of Atlanta  3
2011First Recorded Clinical Trial
2 TrialsResearching Malignant Solid Neoplasms
59 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
The prognosis of greater than six months as determined by their primary oncologist.
You have a score of 10 or more on the DS-II.
You have a positive pregnancy test if you are younger than 26 years old or older than 85 years old.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.