Trial Title:
A Second Psilocybin Group Therapy for the Treatment of Cancer-Related Anxiety in Partial Responders With Metastatic Cancer
NCT ID:
NCT06644170
Condition:
Hematopoietic and Lymphatic System Neoplasm
Metastatic Malignant Solid Neoplasm
Conditions: Official terms:
Neoplasms
Neoplasm Metastasis
Psilocybin
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Behavioral Intervention
Description:
Attend individual visits
Arm group label:
Treatment (psilocybin, group therapy)
Other name:
Psychedelic therapy
Intervention type:
Behavioral
Intervention name:
Group Therapy
Description:
Attend group visits
Arm group label:
Treatment (psilocybin, group therapy)
Intervention type:
Drug
Intervention name:
Psilocybin
Description:
Given PO
Arm group label:
Treatment (psilocybin, group therapy)
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
Treatment (psilocybin, group therapy)
Summary:
This phase I trial tests the safety and side effects of a second episode of
psilocybin-assisted group therapy and how well it works in treating anxiety and distress
in patients with cancer that has spread from where it first started (primary site) to
other places in the body (metastatic) and had a partial response to their first retreat.
Up to 50% of patients with metastatic cancer have clinically significant anxiety and
unaddressed anxiety and distress may add to the suffering caused by cancer itself.
Psilocybin, a psychedelic drug, is made using an extract from the psilocybe mushroom,
also known as "magic mushrooms". Psilocybin binds to serotonin receptors (natural body
chemicals that control moods) on brain cells producing intense changes in mood, including
anxiety. This may change perceptions and patterns of thinking in ways that may decrease
anxiety. Group therapy may reduce stress and improve the well-being and quality of life
of patients with metastatic cancer. A second episode of psilocybin-assisted group therapy
may be safe, tolerable and or effective in treating anxiety and distress in partial
responders with metastatic cancer.
Detailed description:
OUTLINE:
Patients receive psilocybin orally (PO) with optional booster dose on day 0. Patients
attend an individual prep visit on day -1 and an individual integration visit on day 1.
Patients also attend group preparation visits on days -14, -7 and -1 and group
integration visits on days 1, 8, 22 and 36.
After completion of study treatment, patients are followed up at 2, 3, and 6 months.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Participation in BACK002, with outcome measures that showed: a low Mystical
Experience Questionnaire (MEQ) score, OR a small (or negative) Hospital Anxiety and
Depression Scale (HADS) change score, OR a last HADS score that was 11 or greater
- A diagnosis of metastatic solid tumor, or incurable hematologic malignancy that has
been accepted by a physician in a medical record
- Measurable disease is not required
- Previous treatment with chemotherapy: There are no minimum or maximum prior lines of
chemotherapy
- 18-85 years of age
- Required performance status, including the appropriate scale. Eastern Cooperative
Oncology Group (ECOG) 0-2
- Hematocrit > 20
- Platelets (Plt) > 20K
- Liver function tests 1.5 x normal
- Creatinine 1.5 x normal
- Subjects of childbearing potential must be willing to use an effective contraceptive
method from study enrollment until at least 1 month after receiving the
investigational agent(s)
- Must be at least 4 weeks after surgery or radiotherapy at study entry, but can be
receiving oral or intravenous (IV) chemotherapy if those schedules can be adjusted
around the medication session date
- Motivated to participate in a group study and able in the research team's judgment
to participate in the small group effectively
- On pre-enrollment screening tests, they will have clinically significant anxiety or
depressive symptoms as defined by a score of 11 or greater on the HADS-Total
- English speaking - able to understand the process of consent and the risk and
benefits associated with the study, and able to give written informed consent. This
is a pilot study, and if future larger studies are designed, consideration will be
given for non-english-speaking subjects
- Must be willing to sign a medical release for the investigators to communicate
directly with their treating clinicians (mental health professional or oncologist)
and doctors to confirm a medication and/or medical history
- Must provide at least one adult who is in contact with the participant at least once
a day when the participant is at home for the first day after returning home who is
able to verbally monitor participant-reported changes in the behavior and able to
notify research staff of behavior changes that may require research staff assessment
- (In BACK002, participants were required to taper off selective serotonin reuptake
inhibitors [SSRIs] in this study they will be allowed to continue.) Must provide a
review of any SSRI use since completing BACK002
- Must avoid taking any psychiatric medications or starting a new psychiatric
medication during the study. Should participant's doctor recommend starting a new
psychiatric medication, participant will be required to notify the study team and
the subject would withdraw from the study. (Use of as needed [prn] benzodiazepines
is allowed but high dose chronic benzodiazepine use must be reviewed by the
principal investigator [PI]. Use of prn gabapentoids is allowed but high dose
chronic gabapentoid use must be reviewed by the PI.)
- Must provide a contact (relative, spouse, close friend, or other caregiver) who is
willing and able to be reached by the research team in the event that the
participant becomes suicidal
- If the potential participant is of childbearing potential, they must have a negative
pregnancy test at baseline and prior to the medication dosing session, and must
agree to use adequate birth control
- Are willing to commit to preparation sessions, medication dosing sessions,
integration sessions, to complete evaluation instruments and commit to be contacted
for all necessary telephone contacts
- Must have had serum lab tests within 1 week of the retreat showing values for
potassium (K), magnesium (Mg), and calcium in the normal range. (Electrolyte
repletion and rechecking of serum labs is allowed to establish eligibility.)
Exclusion Criteria:
- Brain metastases that have not been treated
- Uncontrolled or concurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance
with study requirements
- Pregnancy, breastfeeding, or expecting to conceive or father children for the
duration of the trial through 30 days after receipt of investigational agent(s)
- Personal or immediate family history of schizophrenia, bipolar affective disorder,
delusion disorder, paranoid disorder, or schizoaffective disorder
- Suicidal ideation with a Columbia-Suicidality Severity Rating Scale (C-SSRS) ≥ 3
- Current substance abuse disorder (although prospective subjects will not be excluded
for reasonable alcohol use that does not meet criteria for alcohol use disorder or
marijuana use that does not meet criteria for substance use disorder)
- Unstable neurological or medical condition; history of seizure, chronic/severe
headaches
- Any use of psychedelic drugs in high doses (psilocybin > 2 grams of dried mushrooms,
lysergic acid diethylamide (LSD) > 200 micrograms) within the prior 3 months
(microdosing will not require exclusion but participants would have to agree to
discontinue microdosing 1 month before study entry)
- Use of tramadol, due to the potential for serotonin syndrome with concomitant use of
psilocybin
- Individuals who are on MAOI (monoamine oxidase inhibitors) or who have a known
sensitivity to the drug or its metabolites. Psilocybin is contraindicated in
medications that are known UGT (UDP-glucuronosyltransferase) enzyme modulators
- Baseline prolongation of QT/corrected QT (QTc) interval (e.g., demonstration on an
eligibility 12-lead electrocardiogram [ECG] of a QTc interval > 450 milliseconds
[ms])
- A history of additional risk factors for Torsade de Points (including but not
limited to: heart failure, hypokalemia, family history of long QT syndrome)
- The use of concomitant medications that prolong the QT/QTc interval
- Any history of cardiovascular disease such as history of myocardial infarction or
congestive heart failure or cardiac arrhythmia
- Concomitant use of efavirenz (an antiviral) which cannot be tapered
- Concomitant use of serotonin-acting supplements due to their potential for
interaction with psilocybin, including oxitriptan (5-HTP), St John's Wort, and
'brain food' supplements
Gender:
All
Minimum age:
18 Years
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fred Hutch/University of Washington Cancer Consortium
Address:
City:
Seattle
Zip:
98109
Country:
United States
Status:
Recruiting
Contact:
Last name:
Anthony L. Back, MD
Phone:
206-619-4367
Email:
tonyback@uw.edu
Investigator:
Last name:
Anthony L. Back, MD
Email:
Principal Investigator
Start date:
December 1, 2024
Completion date:
March 1, 2026
Lead sponsor:
Agency:
University of Washington
Agency class:
Other
Collaborator:
Agency:
Steven & Alexandra Cohen Foundation
Agency class:
Other
Source:
University of Washington
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06644170
