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 Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05506982
• Other study ID #: STUDY00001905
• Secondary ID: NCI-2020-13913ST
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: November 1, 2022
• Est. completion date: August 31, 2024

Study information

• Verified date: January 2024
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 11
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 26 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• Renal insufficiency as evidenced by creatinine clearance (CrCl) < 30 mL/min
• Concomitant use of drugs known to interact with psilocybin (probenecid, diclofenac)
• Consistent use of serotonergic drugs including selective serotonin reuptake inhibitors (SSRIs), serotoninnorepinephrine reuptake inhibitors (SNRIs), or efavirenz, as well as monoamine oxidase inhibitors (MAOIs). Subjects using any other antidepressant, stimulant, or antipsychotic medications on Day 0 (baseline visit) may be allowed to enroll in the study if they elect to taper off the medications under medical supervision by the PI and the study psycho-oncologist (PO) by the day prior to the baseline visit
• Considered by the principal investigator to be inappropriate for the study due to safety concerns or to be unlikely to complete the protocol

Related Conditions & MeSH terms

• Chronic Pain
• Hematopoietic and Lymphoid Cell Neoplasm
• Malignant Solid Neoplasm
• Neoplasms

Intervention

Drug:
• Psilocybin
Given PO

Behavioral:
• Psychotherapy
supportive care

Other:
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Brain Health Center at Executive Park	Atlanta	Georgia
United States	Emory University/Winship Cancer Institute	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Evaluate for Changes in Demoralization at Forty-Two Days	Evaluate demoralization using the Demoralization Scale from baseline to end-of-treatment to 3.5-month follow up. Moderate-to-severe demoralization (score of = 10 on the Demoralization Scale-II).	At 42 days
Other	Evaluate for Changes in Demoralization at Ninety-Eight Days	Evaluate demoralization using the Demoralization Scale from baseline to end-of-treatment to 3.5-month follow up. Moderate-to-severe demoralization (score of = 10 on the Demoralization Scale-II).	At 98 days
Other	Impact of Pain Intensity and Interference with Daily Functioning at Forty-Two Days	The impact of pain intensity and interference with daily functioning will be assessed using Brief Pain Inventory. Chronic pain (pain lasting > 3 months per patient report) and score of = 5 for average pain level on Brief Pain Inventor.	At 42 days
Other	Impact of Pain Intensity and Interference with Daily Functioning at Ninety-Eight Days	The impact of pain intensity and interference with daily functioning will be assessed using Brief Pain Inventory. Chronic pain (pain lasting > 3 months per patient report) and score of = 5 for average pain level on Brief Pain Inventor.	At 98 days
Other	Global Symptom Burden at Forty-Two Days	Global symptom burden will be evaluated using the Edmonton Symptom Assessment Scale.The scale ranges from 0 representing no symptom to 10 representing maximum symptom.	At 42 days
Other	Global Symptom Burden at Ninety-Eight Days	Global symptom burden will be evaluated using the Edmonton Symptom Assessment Scale.The scale ranges from 0 representing no symptom to 10 representing maximum symptom.	At 98 days
Other	Anxiety and Depression at Forty-Two Days	Anxiety and Depression is evaluated using the Hospital Anxiety and Depression Scale.; The Hospital Anxiety and Depression Scale is a 14-item self-report scale and reliable instrument for detecting states of depression and anxiety in outpatient settings, where 0-7 = Normal, 8-10 = Borderline abnormal (borderline case) and 11-21 = Abnormal (case).	At 42 days
Other	Anxiety and Depression at Ninety-Eight Days	Anxiety and Depression is evaluated using the Hospital Anxiety and Depression Scale.; The Hospital Anxiety and Depression Scale is a 14-item self-report scale and reliable instrument for detecting states of depression and anxiety in outpatient settings, where 0-7 = Normal, 8-10 = Borderline abnormal (borderline case) and 11-21 = Abnormal (case).	At 98 days
Other	Quality of Life Assessment at Forty-Two Days	Evaluated quality of life changes from baseline to end-of-treatment to 3.5-month follow up using the Harvard Flourishing Measure. Life Satisfaction (Items 1-2) ranges from 0 = Not Satisfied at All, 10 = Completely Satisfied, Mental and Physical Health (3-4) ranges from 0 = Poor, 10 = Excellent, Meaning and Purpose (5-6) ranges from 0 = Not at All Worthwhile, 10 = Completely Worthwhile and 0 = Strongly Disagree, 10 = Strongly Agree, Character and Virtue (7-8) ranges from 0 = Not True of Me, 10 = Completely True of Me, and Close Social Relationships (9-10) ranges from 0 = Strongly Disagree, 10 = Strongly Agree. A sixth domain, Financial and Material Stability (11-12) may be necessary to sustain the other domains over time ranges from 0 = Worry All of the Time, 10 = Do Not Ever Worry.; .	At 42 days
Other	Quality of Life Assessment at Ninety-Eight Days	Evaluated quality of life changes from baseline to end-of-treatment to 3.5-month follow up using the Harvard Flourishing Measure. Life Satisfaction (Items 1-2) ranges from 0 = Not Satisfied at All, 10 = Completely Satisfied, Mental and Physical Health (3-4) ranges from 0 = Poor, 10 = Excellent, Meaning and Purpose (5-6) ranges from 0 = Not at All Worthwhile, 10 = Completely Worthwhile and 0 = Strongly Disagree, 10 = Strongly Agree, Character and Virtue (7-8) ranges from 0 = Not True of Me, 10 = Completely True of Me, and Close Social Relationships (9-10) ranges from 0 = Strongly Disagree, 10 = Strongly Agree. A sixth domain, Financial and Material Stability (11-12) may be necessary to sustain the other domains over time ranges from 0 = Worry All of the Time, 10 = Do Not Ever Worry.	At 98 days
Other	Caregiver strain at Forty-Two Days	The Measured by the Modified Caregiver Strain Index is a 13-item tool measuring strain related to care provision with at least one item for each of the following major domains: financial, physical, psychological, social, and personal. The instrument is used to assess individuals of any age who assume the role of care giving.The index ranges from: Yes, On a Regular Basis=2, Yes, Sometimes =1, and No=0.	At 42 days
Other	Caregiver strain at Ninety-Eight Days	The Measured by the Modified Caregiver Strain Index is a 13-item tool measuring strain related to care provision with at least one item for each of the following major domains: financial, physical, psychological, social, and personal. The instrument is used to assess individuals of any age who assume the role of care giving.The index ranges from: Yes, On a Regular Basis=2, Yes, Sometimes =1, and No=0.	At 98 days
Other	Impact of pain intensity and interference with catastrophizing through rumination, helplessness, and pessimism at Forty-Two Days	Evaluated using the Pain Catastrophizing Scale. Where 0=Not at all, 1=To a slight degree, 2=To a moderate degree, 3=To a great degree, 4= All the time.	At 42 days
Other	Impact of pain intensity and interference with catastrophizing through rumination, helplessness, and pessimism at Ninety-Eight Days	Evaluated using the Pain Catastrophizing Scale. Where 0=Not at all, 1=To a slight degree, 2=To a moderate degree, 3=To a great degree, 4= All the time.	At 98 days
Other	Religious and spiritual assessment at Forty-Two Days	Evaluated using Santa Clara Strength of Religious Faith Questionnaire. 1 = strongly disagree, 2 = disagree, 3 = agree and 4 = strongly agree.	At 42 days
Other	Religious and spiritual assessment at Ninety-Eight Days	Evaluated using Santa Clara Strength of Religious Faith Questionnaire. 1 = strongly disagree, 2 = disagree, 3 = agree and 4 = strongly agree.	At 98 days
Other	Social connectedness at Forty-Two Days	Evaluated using the Social Connectedness Scale-Revised. The Social Connectedness Scale-Revised is a validated 8-item self-report measure assessing the degree to which subjects feel socially connected as a psychological sense of belonging. Where 1= Strongly Disagree, 2= Disagree, 3=Mildly Disagree, 4= Mildly Agree, 5= Agree, 6= Strongly Agree	At 42 days
Other	Social connectedness at Ninety-Eight Days	Evaluated using the Social Connectedness Scale-Revised. The Social Connectedness Scale-Revised is a validated 8-item self-report measure assessing the degree to which subjects feel socially connected as a psychological sense of belonging. Where 1= Strongly Disagree, 2= Disagree, 3=Mildly Disagree, 4= Mildly Agree, 5= Agree, 6= Strongly Agree	At 98 days
Other	Self-reported opioid use in the form of oral morphine equivalents over past week at Forty-Two Days	Opioid use in the form of oral morphine equivalents.	At 42 days
Other	Self-reported opioid use in the form of oral morphine equivalents over past week at Ninety-Eight Days	Opioid use in the form of oral morphine equivalents.	At 98 days
Other	Self-reported polypharmacy over past week at Forty-Two Days	The number of total medications used to manage physical and emotional symptoms	At 42 days
Other	Self-reported polypharmacy over past week	The number of total medications used to manage physical and emotional symptoms	At 98 days
Other	Global psychosocial functioning (participant and caregiver) at Forty-Two Days	Evaluated using using the Work and Social Adjustment Scale. It is a 5-item measure of general social impairment, and specifically their ability to function in terms of work, tasks at home, social leisure, private leisure, and personal or family relationships. Score: 0-9= low impairment, 10-19= moderate impairment, 20-40 severe impairment.	At 42 days
Other	Global psychosocial functioning (participant and caregiver) at Ninety-Eight Days	Evaluated using using the Work and Social Adjustment Scale. It is a 5-item measure of general social impairment, and specifically their ability to function in terms of work, tasks at home, social leisure, private leisure, and personal or family relationships. Score: 0-9= low impairment, 10-19= moderate impairment, 20-40 severe impairment.	At 98 days
Primary	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
Primary	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