Hematopoietic and Lymphoid Cell NeoplasmPhase 1NCT05506982
Psilocybin Combined With Multidisciplinary Palliative Care in Demoralized Cancer Survivors With Chronic Pain
A Phase 1 study testing Psilocybin, Psychotherapy and Quality-of-Life Assessment in people with Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by Emory University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 26 years and older
- Conditions the study is for
- Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Psilocybin, Psychotherapy and Quality-of-Life Assessment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Nov 2022to 24 Jan 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 26 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Emory University/Winship Cancer Institute
Atlanta, Georgia, 30322
Brain Health Center at Executive Park
Atlanta, Georgia, 30329
About this study
Official title: The Safety, Feasibility, and Acceptability of Psilocybin Combined With Multidisciplinary Palliative Care in Demoralized Cancer Survivors With Chronic Pain (P-PC)
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
- Being tested
- Psilocybin, Psychotherapy, Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsilocybinDrug
Also called CY-39, Indocybin
Given PO
PsychotherapyBehavioural
Also called talk therapy
supportive care
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (psilocybin, observation) | Experimental | Patients receive psilocybin PO and undergo observation for up to 24 hours on day 14. Receives: Drug: Psilocybin; Behavioral: Psychotherapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2022
- Study start1 Nov 2022
- Primary completion25 Apr 2024
- Study completion24 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphoid Cell NeoplasmStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Ali Zarrabi, Emory University
- Investigators
- Ali J. Zarrabi, MD, Principal investigator, Emory University Hospital/Winship Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05506982
- Sponsor's protocol ID
- STUDY00001905
- Other IDs
- NCI-2020-13913, STUDY00001905, EU5206-20, P30CA138292
- Status last verified
- Jul 2025
- First submitted
- 6 Aug 2022
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety, Feasibility, and Acceptability of Psilocybin Combined With Multidisciplinary Palliative Care in Demoralized Cancer Survivors With Chronic Pain (P-PC)
- ClinicalTrials.gov ID
- NCT05506982
- Acronym / sponsor ID
- STUDY00001905
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 25 Apr 2024 (actual)
- Study completion
- 24 Jan 2025 (actual)
- First posted
- 18 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (psilocybin, observation) | Experimental | Drug: Psilocybin, Behavioral: Psychotherapy, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients receive psilocybin PO and undergo observation for up to 24 hours on day 14. |
Who may qualify
- Ages
- 26 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PsilocybinAlso: CY-39, IndocybinGiven PO | Drug | Supportive care (psilocybin, observation) |
| PsychotherapyAlso: talk therapysupportive care | Behavioural | Supportive care (psilocybin, observation) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Supportive care (psilocybin, observation) |
| Questionnaire AdministrationAncillary studies | Other | Supportive care (psilocybin, observation) |
Primary outcome
Incidence Of Treatment-Related Medical Grade 3 Or Higher Or Psychiatric Grade 4 Or Higher
Time frame: Up to 42 days
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.
Evaluation of Feasibility Outcome To Assess Patient Retention in The Study
Time frame: Up to 42 days
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali J. Zarrabi, MD principal investigator
Emory University Hospital/Winship Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Psilocybin, Psychotherapy and Quality-of-Life Assessment in people with Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by Emory University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence Of Treatment-Related Medical Grade 3 Or Higher Or Psychiatric Grade 4 Or Higher (time frame: Up to 42 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.