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Psilocybin with Psychotherapy for Chronic Pain in Cancer Patients

This study is looking at whether psilocybin, a substance from a mushroom, combined with psychotherapy (talk therapy), can safely help cancer patients who are experiencing chronic pain and need opioids. Psilocybin can cause hallucinations, which might affect how you experience "total pain" – this includes psychological, spiritual, and social factors. Psychotherapy helps you learn new ways to react to things that might make your pain worse. The study aims to see if this combination can reduce your pain and possibly your need for opioids. You can join if you are 18 to 75 years old, have active cancer, and experience moderate to severe pain. The study will also look at how psilocybin works in the brain and its effects on inflammation and psychological well-being.

Study design
This interventional study plans to enroll 20 participants. It is a Phase II trial, meaning it's an early-stage study to evaluate safety and effectiveness.
What's involved
You would attend two preparatory psychotherapy sessions, undergo biospecimen collection (blood and urine samples), have functional magnetic resonance imaging (fMRI) scans, and receive psilocybin orally.
Compensation
Not stated in the trial record.
Follow-up
Your vital signs will be measured up to day 84. Adverse events will be tracked for 30 days after your last intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06827054

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

Not Yet Recruiting
PHASE2Ages 18–75InterventionalSupportive care
Roswell Park Cancer Institute
~20 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:Biospecimen CollectionFunctional Magnetic Resonance ImagingInterviewPsilocybinePsychotherapyQuestionnaire Administration

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of adverse events (AEs)
Measured over From start date of intervention to 30 days after the last intervention
+6 more outcomes measured

Conditions

Hematopoietic and Lymphatic System Neoplasm
Malignant Solid Neoplasm

Explore related trials

Hematopoietic and Lymphatic System NeoplasmMalignant Solid Neoplasm

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • William Alexander · PRINCIPAL_INVESTIGATOR · Roswell Park Cancer Institute

Who to contact

William Alexander
[email protected]
716-845-1479
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
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

Exclusion

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
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

What this trial measures

  • Incidence of adverse events (AEs)From start date of intervention to 30 days after the last intervention

    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.

  • Change in Vital signsUp to baseline, dosing sessions 1 and 2 up to day 84

    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.

  • Incidence of clinically important changes in ICG parametersAt baseline and day 28

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

  • Change in risk for suicideAt baseline, dosing sessions 1, 2, 3, 5, and 7, and days 28, 56, and 84

    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.

  • Change in cognitive functionAt dosing sessions 1-3 and days 28, 56, and 84

    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.

  • Recruitment rateUp to day 84

    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.

  • Retention rateUp to day 84

    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.