Clinical trial NCT05506982: Psilocybin Combined With Multidisciplinary Palliative Care in Demoralized Cancer Survivors With Chronic Pain
Official title: The Safety, Feasibility, and Acceptability of Psilocybin Combined With Multidisciplinary Palliative Care in Demoralized Cancer Survivors With Chronic Pain (P-PC)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2022-08-18
Enrollment: 11
Sex: ALL
Minimum age (years): 26
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence Of Treatment-Related Medical Grade 3 Or Higher Or Psychiatric Grade 4 Or Higher
timeFrame: Up to 42 days
measure: Evaluation of Feasibility Outcome To Assess Patient Retention in The Study
timeFrame: Up to 42 days
Secondary outcomes:
Other outcomes:
measure: Evaluate for Changes in Demoralization at Forty-Two Days
timeFrame: At 42 days
measure: Evaluate for Changes in Demoralization at Ninety-Eight Days
timeFrame: At 98 days
measure: Impact of Pain Intensity and Interference with Daily Functioning at Forty-Two Days
timeFrame: At 42 days
measure: Impact of Pain Intensity and Interference with Daily Functioning at Ninety-Eight Days
timeFrame: At 98 days
measure: Global Symptom Burden at Forty-Two Days
timeFrame: At 42 days
measure: Global Symptom Burden at Ninety-Eight Days
timeFrame: At 98 days
measure: Anxiety and Depression at Forty-Two Days
timeFrame: At 42 days
measure: Anxiety and Depression at Ninety-Eight Days
timeFrame: At 98 days
measure: Quality of Life Assessment at Forty-Two Days
timeFrame: At 42 days
measure: Quality of Life Assessment at Ninety-Eight Days
timeFrame: At 98 days
measure: Caregiver strain at Forty-Two Days
timeFrame: At 42 days
measure: Caregiver strain at Ninety-Eight Days
timeFrame: At 98 days
measure: Impact of pain intensity and interference with catastrophizing through rumination, helplessness, and pessimism at Forty-Two Days
timeFrame: At 42 days
measure: Impact of pain intensity and interference with catastrophizing through rumination, helplessness, and pessimism at Ninety-Eight Days
timeFrame: At 98 days
measure: Religious and spiritual assessment at Forty-Two Days
timeFrame: At 42 days
measure: Religious and spiritual assessment at Ninety-Eight Days
timeFrame: At 98 days
measure: Social connectedness at Forty-Two Days
timeFrame: At 42 days
measure: Social connectedness at Ninety-Eight Days
timeFrame: At 98 days
measure: Self-reported opioid use in the form of oral morphine equivalents over past week at Forty-Two Days
timeFrame: At 42 days
measure: Self-reported opioid use in the form of oral morphine equivalents over past week at Ninety-Eight Days
timeFrame: At 98 days
measure: Self-reported polypharmacy over past week at Forty-Two Days
timeFrame: At 42 days
measure: Self-reported polypharmacy over past week
timeFrame: At 98 days
measure: Global psychosocial functioning (participant and caregiver) at Forty-Two Days
timeFrame: At 42 days
measure: Global psychosocial functioning (participant and caregiver) at Ninety-Eight Days
timeFrame: At 98 days
Locations:
city: Atlanta
country: United States
facility: Emory University/Winship Cancer Institute
state: Georgia
city: Atlanta
country: United States
facility: Brain Health Center at Executive Park
state: Georgia
Study officials:
affiliation: Emory University Hospital/Winship Cancer Institute
name: Ali J. Zarrabi, MD
role: PRINCIPAL_INVESTIGATOR
References: