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Hematopoietic and Lymphatic System NeoplasmPhase 2NCT06827054

Psilocybin With Psychotherapy for Improving Chronic Pain in Cancer Patients Requiring Opioids

A Phase 2 study testing Biospecimen Collection, Functional Magnetic Resonance Imaging and Interview in people with Hematopoietic and Lymphatic System Neoplasm and Malignant Solid Neoplasm, run by Roswell Park Cancer Institute at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This phase II trial studies whether psilocybin with psychotherapy is safe and if it works for improving chronic pain in cancer patients who require opioids to manage their pain. Psilocybin is taken from the mushroom Psilocybe mexicana. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Biospecimen Collection, Functional Magnetic Resonance Imaging and Interview
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
15 Dec 2026to 5 May 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 and ≤ 75 years old
  • Diagnosis of active cancer, any stage
  • Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
  • Estimated prognosis of ≥ 3 months at the time of enrollment, determined by participant's primary oncologist or palliative physician
  • Diagnosis of moderate to severe pain (reported average pain score ≥ 4 on the 11-point Numerical Rating Scale) that is chronic (≥ 3 months) and secondary to cancer or cancer treatment
  • Pain regimen has been escalated to opioid therapy
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  • Participants must be on stable pain regimen for at least one month prior, with no intention to adjust pain regimen during the study period
  • Participants must be ≥ 4 weeks beyond treatments/procedures that, in the opinion of the study physician, would significantly affect outcomes related to pain and physical function (e.g., surgery or radiation). Participants may otherwise receive cancer-directed treatment throughout the study period
  • Have no known procedures/treatments scheduled in advance that would prohibit patient from completing or significantly delaying completion of the study
  • The participant has no vacations or plans to be out of town during their study enrollment
  • Participants must not plan for additional treatments/procedures that, in the opinion of the study physician, would significantly affect outcomes related to pain and physical function (e.g., surgery or radiation) for ≥ 4 weeks following psilocybin treatment initiation. Participants may otherwise receive cancer-directed treatment throughout the study period
  • No use of other illicit substances (excluding cannabis) within the past year based on self-report at screening and routine urine toxicology screen
  • Participants must be able to read, write, and speak English
  • Participants must be able to swallow pills
  • Agree to refrain from using any unprescribed psychoactive drugs, including alcoholic beverages, ≤ 24 hours of before each psilocybin administration. Exceptions include:
  • Daily use of caffeine or nicotine
  • Prescribed benzodiazepine medications and non-benzodiazepine sleeping medications will be allowed to continue through the study period for participants who have been on a stable dose of such a medicine for ≥ 6 weeks prior to screening
  • Participants using cannabis, including legal cannabis, for any purpose must agree to refrain from use beginning at two weeks before dosing and one week following completion of dosing (7-8 weeks total, dependent on frequency of prior use)
  • Participants will not be withdrawn from the trial for a positive cannabis result during the initial screening drug test. However, participants who test positive for cannabis at the second drug test on visit 10 will be withdrawn from the trial
  • Participants must agree to be driven home after each experimental session and not drive or operate heavy machinery ≤ 16 hours of ingesting psilocybin
  • Participants must provide an emergency contact (relative, spouse, close friend, or other support person) willing and able to be reached by the investigators if the participant is unreachable by study staff or in an emergency
  • The participant agrees to take part in all study procedures, including the assessments, psychological evaluations, and dosing day requirements
  • Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Who cannot join

  • Participants who are pregnant or breast-feeding
  • Participants of childbearing potential who decline to use a highly effective dual contraceptive method for the duration of the study
  • Participants with a condition impairing oral intake or digestive absorption
  • Cognitive impairment as defined by Montreal Cognitive Assessment (MOCA) score < 23
  • Medical conditions or serious abnormalities of complete blood count, chemistries, or electrocardiography (ECG) that in the opinion of the study physician would preclude safe participation in the trial. Some examples include: congestive heart failure, valvular heart disease, recent acute myocardial infarction or evidence of ischemia, clinically significant arrhythmias (e.g., ventricular fibrillation, torsades) or clinically significant ECG abnormality (e.g. corrected QT interval using Fridericia's Correction Formula [QTcF] interval > 450 in males and > 470 in females), uncontrolled hypertension (systolic blood pressure [BP] ≥ 140 or diastolic BP ≥ 90 on three separate occasions), congenital long QT syndrome, renal dysfunction (i.e. creatinine clearance [CrCl] < 40 mL/min), liver cirrhosis or hepatic dysfunction (indicated by gamma-glutamyltransferase [GGT], aspartate aminotransferase [AST], or alanine aminotransferase [ALT] > 3 x ULN [upper limit of norm] or total bilirubin [bili] > 3.0 mg/dl, or Child Pugh over class C), paraneoplastic syndrome, respiratory failure, dementia, delirium, known cerebral aneurysm, seizure disorder, stroke/transient ischemic attack (TIA) in past year, cancer with known central nervous system (CNS) involvement, previously treated brain metastasis, or other major CNS disease
  • Participants who have a personal history of, or a current diagnosis of the following: primary psychotic disorder, major depressive disorder with psychotic features, bipolar affective disorder type 1 or history of or current dissociative identity disorder
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  • Participants who have an ongoing substance use disorder (defined as active in the past year)
  • Participants with first-degree relatives with schizophrenia or bipolar disorder may be eligible depending on their age and personal and family psychiatric history. The decision will be made by the principal investigator and study psychiatrist or on-call psychiatric provider based on risk assessment
  • Active suicidal behavior (interrupted or aborted attempt; preparatory acts) as assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) connotating either passive or active suicidal intent; OR one of the following:
  • History of suicide attempt(s) within the past year (≤ 365 days)
  • Have any suicidal ideation or thoughts, in the opinion of the study physician or principal investigator (PI), that presents a serious risk of suicidal or self-injurious behavior
  • Any contraindications to undergoing an fMRI scan, including having metal implants or metal fragments in the body
  • Participants who have hypersensitivity to the ingredients of the IMP (Investigational Medicinal Product) listed below:
  • Indol alkaloids including psilocybin and psilocin
  • Constituents of Psilocybe cubensis including protein, fats, carbohydrates, ergosterols, beta-glucan, and polyphenols
  • Hydroxypropyl methylcellulose (HPMC) capsules
  • Participants who are taking medications with significant potential to interact with study medications will be exclusionary if they cannot be tapered. The taper interval will be at least five times the half-life. These medications include the following:
  • Selective serotonin reuptake inhibitors (SSRIs)
  • Serotonin and norepinephrine reuptake inhibitors (SNRIs)
  • Tricyclic antidepressants (TCAs)
  • Efavirenz
  • Serotonin-acting dietary supplements (i.e., 5-hydroxy-tryptophan or St. John's wort)
  • Centrally acting serotonergic agents (e.g., monoamine oxidase [MAO] inhibitors)
  • Antipsychotics for a psychiatric disorder (e.g., first and second generation)
  • Antipsychotics that are utilized for nausea, insomnia, or other non-psychiatric condition will be permitted, but patients will be asked to refrain from use 8 hours prior to dosing sessions
  • Mood stabilizers (e.g., lithium, valproic acid)
  • Aldehyde dehydrogenase inhibitors (e.g., disulfiram)
  • Significant inhibitors of UGT 1A9 or UGT 1A10
  • Use of serotonergic hallucinogens (e.g., psilocybin, lysergic acid diethylamine [LSD]) within the past 12 months or significant lifetime use (> 25 uses)
  • Those with a history of prior violent and/or drug-related felonies
  • Those currently incarcerated will be excluded
  • Unwilling or unable to follow protocol requirements
  • Any social circumstance which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

    William Alexander, 716-845-1479, William.Alexander@roswellpark.org

    William Alexander

Other trials in United States

About this study

Official title: Low-Dose Psilocybin Therapy for Palliative Care Patients With Chronic Cancer Pain Requiring Opioids

This phase II trial studies whether psilocybin with psychotherapy is safe and if it works for improving chronic pain in cancer patients who require opioids to manage their pain. Psilocybin is taken from the mushroom Psilocybe mexicana. Psilocybin acts on the brain to cause hallucinations (sights, sounds, smells, tastes, or touches that a person believes to be real but are not real). This may impact a patient's "total pain", a view that accounts for the psychological, spiritual, and social factors that contribute to their experience of pain. Psychotherapy uses methods such as discussion, listening, and counseling to help patients change the way they react to environmental triggers that may cause a negative reaction. Giving psilocybin with psychotherapy may be safe and helpful for improving chronic pain in cancer patients who require opioids to manage their pain.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To evaluate the safety, tolerability, and feasibility of low dose psilocybin therapy in patients with chronic cancer pain who require opioids.

SECONDARY OBJECTIVE:

  1. To obtain preliminary evidence for efficacy of low dose psilocybin therapy in reducing pain and opioid requirement in participants with chronic cancer pain.

EXPLORATORY OBJECTIVES:

  1. To evaluate potential mechanisms of action for psilocybin in pain control, including its effects on resting brain network activity, inflammation, and psychological changes processes.

II. To obtain preliminary evidence for efficacy of psilocybin therapy on additional outcomes related to pain control, physical function, and opioid requirement in participants with chronic cancer pain.

III. To obtain preliminary evidence for efficacy of low dose psilocybin therapy in alleviating psychological symptoms associated with chronic cancer pain.

IV. To evaluate potential mechanisms of action for low dose psilocybin therapy in pain control, including its effects on the following: resting brain network activity, inflammation, psychological processes and psychedelic effects.

OUTLINE:

Patients attend two preparatory psychotherapy sessions. Patients then receive psilocybin orally (PO) twice a week (BIW) for 4 weeks (8 doses total) in the absence of unacceptable toxicity and attend three integration psychotherapy sessions over 1.5 hours each during psilocybin dosing sessions 2, 4, and 6. Patients may optionally attend additional psychotherapy sessions as needed during follow-up. Additionally, patients undergo functional magnetic resonance imaging (fMRI) and collection of blood and urine samples throughout the study.

After completion of study intervention, patients are followed up at days 28-34, 56, and 84.

Being tested
Biospecimen Collection, Functional Magnetic Resonance Imaging, Interview, Psilocybine, Psychotherapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo collection of blood and urine samples

  • Functional Magnetic Resonance ImagingProcedure or surgery

    Also called fMRI, Functional MRI

    Undergo fMRI

  • InterviewOther

    Ancillary studies

  • PsilocybineDrug

    Also called CY-39, Indocybin, Psilocybin

    Given PO

  • PsychotherapyBehavioural

    Also called talk therapy

    Attend psychotherapy sessions

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT06827054
Study groupRoleWhat they receive
Supportive care (psychotherapy, psilocybin)ExperimentalPatients attend two preparatory psychotherapy sessions. Patients then receive psilocybin PO BIW for 4 weeks (8 doses total) in the absence of unacceptable toxicity and attend three integration psychotherapy sessions over 1.5 hours each during psilocybin dosing sessions 2, 4, and 6. Patients may optionally attend additional psychotherapy sessions as needed during follow-up. Additionally, patients undergo fMRI and collection of blood and urine samples throughout the study.
Receives: Procedure: Biospecimen Collection; Procedure: Functional Magnetic Resonance Imaging; Other: Interview; Drug: Psilocybine; Behavioral: Psychotherapy; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of adverse events (AEs)

    AE assessments will be performed at each treatment session and all subsequent in-person and virtual visits. This will be clinician-observed events. These evaluations will utilize the established Common Terminology Criteria for Adverse Events version 5.0. AEs will be summarized by attribution and grade using frequencies and relative frequencies, where the grade 3+ AE rate will be estimated with 90% credible regions obtained by Jeffrey's prior method. Additionally, a continual safety monitoring plan will be utilized to ensure study suspension should the AE rates exceed pre-defined thresholds.

    Measured: From start date of intervention to 30 days after the last intervention

  2. Change in Vital signs

    Continuous Vital signs will be assessed and summarized by timepoint using the appropriate descriptive statistics. The change in these measures will be modeled as a function of time and a random subject effect using linear mixed models, where tests about the appropriate contrasts of model estimates will be used to identify significant changes relative to pre-treatment levels. All model assumptions will be verified graphically.

    Measured: Up to baseline, dosing sessions 1 and 2 up to day 84

  3. Incidence of clinically important changes in ICG parameters

    To assess any changes in EKG records from baseline EKG to day 28 EKG

    Measured: At baseline and day 28

  4. Change in risk for suicide

    Will be assessed using the Columbia-Suicide Severity Rating Scale. Will be summarized by timepoint using the appropriate descriptive statistics. The change will be modeled as a function of time and a random subject effect using linear mixed models, where tests about the appropriate contrasts of model estimates will be used to identify significant changes relative to pre-treatment levels. All model assumptions will be verified graphically.

    Measured: At baseline, dosing sessions 1, 2, 3, 5, and 7, and days 28, 56, and 84

  5. Change in cognitive function

    A Montreal Cognitive Assessment will be provided prior to the first dosing session, at two-hour intervals during the first two dosing sessions and subsequent dosing sessions if a dose reduction occurred, and once during subsequent visits.

    Measured: At dosing sessions 1-3 and days 28, 56, and 84

  6. Recruitment rate

    Recruitment will be measured as a percentage of participants who were contacted for prescreening that were enrolled. Will be estimated with 90% credible regions obtained by Jeffrey's prior method.

    Measured: Up to day 84

  7. Retention rate

    Retention rate will be measured as a percentage of participants who enrolled that completed the trial, determined by completion of visit 19. Will be estimated with 90% credible regions obtained by Jeffrey's prior method.

    Measured: Up to day 84

Secondary outcomes (2)

  1. Change in average pain intensity

    The reported average pain will be assessed via the Brief Pain Inventory-Short Form, which includes multiple pain-related questions using an 11-point Numerical Rating Scale. A decrease by 30% or 2 points is regarded as clinically meaningful. Will be summarized by timepoint (baseline and by micro-dose session) using the appropriate descriptive statistics and graphical summaries. The log of each outcome will be modeled as a function of timepoint and a random subject effect using a linear mixed model. Tests about the appropriate contrasts of model estimates will be used to evaluate changes of interest. All model assumptions will be verified graphically.

    Measured: At baseline and days 3, 7, 28, 56, and 84

  2. Change in rescue opioid requirement

    Will be measured in Oral Morphine Equivalents. Will be assessed via participant self-report with medication log and further verified with pill count. Will be summarized by timepoint (baseline and by micro-dose session) using the appropriate descriptive statistics and graphical summaries. The log of each outcome will be modeled as a function of timepoint and a random subject effect using a linear mixed model. Tests about the appropriate contrasts of model estimates will be used to evaluate changes of interest. All model assumptions will be verified graphically.

    Measured: At baseline and days 3, 7, 28, 56, and 84

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2025
  2. Study start15 Dec 2026 (estimated)
  3. Primary completion5 May 2027 (estimated)
  4. Study completion5 May 2027 (estimated)

Resources

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 2
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06827054
Sponsor's protocol ID
I-3914823
Other IDs
NCI-2024-10761, I-3914823
Status last verified
Nov 2026
First submitted
22 Jan 2025
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Biospecimen Collection, Functional Magnetic Resonance Imaging and Interview in people with Hematopoietic and Lymphatic System Neoplasm and Malignant Solid Neoplasm, run by Roswell Park Cancer Institute at 1 site 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 23 inclusion and 33 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: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events (AEs) (time frame: From start date of intervention to 30 days after the last intervention). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06827054.

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 5 Nov 2026.

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