Trial Title:
Psilocybin in Cancer Pain Study
NCT ID:
NCT06001749
Condition:
Opioid-Related Disorders
Pain Management
Pain Management and Care
Advanced Cancer
Advanced Cancers
Conditions: Official terms:
Neoplasms
Opioid-Related Disorders
Psilocybin
Conditions: Keywords:
Opioid-Related Disorders
Pain Management
Pain Management and Care
Advanced Cancer
Advanced Cancers
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Psilocybin
Description:
A tryptamine derivative, capsule, taken orally.
Arm group label:
Psilocybin
Summary:
The overall objective of this study is to assess the feasibility, safety and preliminary
efficacy of psilocybin-assisted therapy to alleviate opioid-refractory pain in patients
with advanced-cancer.
The name of the study intervention used in this research study is:
Psilocybin (a tryptamine derivative)
Detailed description:
This study is a phase 2 open label, single center, concurrent mixed-methods trial to
assess the feasibility of a novel palliative-care informed psilocybin-assisted
psychotherapy regimen to alleviate opioid-refractory pain in patients with
advanced-cancer. Psilocybin works on the serotonin system in the brain which is linked to
the regulation of mood, motivation and impulse control.
Psilocybin is an "Investigational" drug, meaning that the study drug has not been
approved by the U.S. Food and Drug Administration (FDA) as a treatment for any disease.
However, investigators have permission from the FDA to use this drug in this research
study.
The research study procedures include screening for eligibility, an electrocardiogram,
blood tests, and the study intervention includes preparation, evaluations, one psilocybin
session and follow up visits.
Participants will be followed for up to 12 weeks (approximately 3 months) after receiving
the study treatment.
It is expected that about 15 people will take part in this research study.
Filament Health is supporting this research study by providing the study investigational
medication, psilocybin.
Cy Biopharma and Pancreatic Cancer North America are supporting this research study by
providing funding.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Participants must be 18 year old or older;
- Participants must have advanced cancer, defined as a cancer that is unlikely to be
cured or controlled with treatment;
- Participants must have progressed on or be intolerant to approved therapies with a
known clinical benefit (unless it is documented that they have refused such
treatments);
- Participants must evaluate their average pain on BPI Severity Scale ≥ 4/10 over the
past week;
- Participants must receive chronic opioid pharmacotherapy for pain with an Oral
Morphine Equivalent (OME) ≥ 200mg/day;
- Participants must have been seen by a palliative care clinician either at DFCI, MGH
or associated satellites in the last three months;
- Participants must have an ECOG Performance Status ≤ 2
- Participants must meet the following organ and marrow function on their last
available bloodwork as defined below:
- Platelets ≥ 50,000/mcL
- AST(SGOT)/ALT(SGPT) ≤ 5 × institutional ULN
- Participants must be able to understand and willing to sign a written informed
consent document
- Participants must be able to swallow pills.
- Participants must provide a contact (relative, spouse, close friend or other support
person) who is willing and able to be reached by the investigators in the event of a
participant becoming suicidal or unreachable.
- Participants must agree to inform the investigators within 48 hours of any new
medical conditions and procedures.
- Participants must agree to the following lifestyle modifications (described in more
detail in Section 3.4 Lifestyle Modifications):
- Comply with requirements for diet,
- Refrain from certain medications prior to Experimental Sessions,
- Be driven home after each Experimental Session,
- Commit to medication dosing, therapy, and study procedures.
Exclusion Criteria:
- Participants who receive concurrent (less than four weeks or planned within 6 weeks)
cytotoxic chemotherapy or radiation therapy that may impair general level of
physical functioning or affect study outcomes;
- Participants with a condition impairing oral intake or digestive absorption;
- Participants who are not able to give adequate informed consent;
- Participants who have a significant suicide risk as defined by suicidal ideation
with intent and with or without a plan as endorsed on items 4 and/or 5 on the C-SSRS
within the past 6 months or at V0
- Participants who have a history of, or a current diagnostic of primary psychotic
disorder, major depressive disorder with psychotic features, bipolar affective
disorder type 1 or history of or current dissociative identity disorder; and
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 based on risk assessment.
- Participants for whom there is a potential for adverse drug-drug interactions.
Concomitant medications with significant potential to interact with study
medications will be exclusionary if they cannot be tapered. These include the
following:
- Serotoninergic antidepressants
- 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. MAO inhibitors)
- Antipsychotics (e.g. first and second generation)
- Mood stabilizers (e.g. lithium, valproic acid)
- Aldehyde dehydrogenase inhibitors (e.g. disulfiram)
- Significant inhibitors of UGT 1A0 or UGT 1A10 Any psychiatric medication will
be tapered if possible in an appropriate fashion to avoid withdrawal effects.
They will be discontinued long enough before the psilocybin Session to avoid
the possibility of any drug-drug interaction (the interval will be at least
five times the particular drug and active metabolites' half-life + one week for
stabilization). See section 5.3 of the protocol for concomitant medications and
tapering instructions.
- Participants who have evidence or history of significant (controlled or
uncontrolled) hematological, endocrine, cerebrovascular, cardiovascular, coronary,
pulmonary, renal, gastrointestinal, immunocompromising, or neurological disease,
including seizure disorder, or any other medical disorder judged by the investigator
to significantly increase the risk of psilocybin administration (participants with
hypothyroidism who are on adequate and stable thyroid replacement will not be
excluded).
- Participants with brain tumors or brain metastases that haven't been successfully
treated
- Participants with lab abnormalities that may contribute to somnolence, confusion or
delayed metabolism of psilocybin and/or with severe lab abnormalities (grade 3 or
more per CTCAE scale).
- Participants with a diagnosis of cirrhosis or liver failure
- Participants who have uncontrolled hypertension using the standard criteria of the
American Heart Association (values of 140/90 milligrams of Mercury [mmHg] or higher
assessed on three separate occasions)
- Participants who have a heart rate > 100 bpm on three separate occasions
- Participants who have a history of ventricular arrhythmia at any time, other than
occasional premature ventricular contractions (PVCs) in the absence of ischemic
heart disease.
- Participants who have Wolff-Parkinson-White syndrome or any other accessory pathway
that has not been successfully eliminated by ablation.
- Participants who have a history of arrhythmia, other than premature atrial
contractions (PACs) or occasional PVCs in the absence of ischemic heart disease,
within 12 months of screening. Participants with a history of atrial fibrillation,
atrial tachycardia, atrial flutter or paroxysmal supraventricular tachycardia or any
other arrhythmia associated with a bypass tract may be enrolled if they have been
successfully treated.
- Participants who have a history of additional risk factors for Torsade de pointes
(e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
- Participants who have a history of myocardial infarction, coronary artery disease or
heart failure
- Participants who have a marked Baseline prolongation of QT/QTc interval. For
purposes of eligibility, this is defined as repeated demonstration of a QT interval
corrected on the triplicate ECGs performed at screening, using Fridericia's formula
[QTcF] > 450 milliseconds [ms] in males and > 460 ms in females.
- For transgender or non binary participants, QTc interval will be evaluated based on
sex assigned at birth, unless the participant has been on hormonal treatment for
five or more years.
- Women who are pregnant, nursing, or able to become pregnant and are not practicing
an effective means of birth control. Acceptable methods of contraception are the
following: intrauterine device, injected/ implanted/ intravaginal/ transdermal
hormonal method, oral hormones plus a barrier contraception, abstinence,
vasectomized sole partner, or double barrier contraception.
- Participants who have hypersensitivity to any ingredient of the IMP (Investigational
Medicinal Product).
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Dana-Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Contact:
Last name:
Isabel Kristan
Phone:
8572151476
Email:
patresearch@dfci.harvard.edu
Contact backup:
Last name:
Yvan Beaussant, MD
Start date:
September 23, 2024
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Yvan Beaussant, MD, MSci
Agency class:
Other
Collaborator:
Agency:
Cy Biopharma
Agency class:
Other
Collaborator:
Agency:
Pancreatic Cancer North America
Agency class:
Other
Source:
Dana-Farber Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06001749
