Group Retreat Psilocybin Therapy for Anxiety and Depression in Advanced Cancer
This study is testing a group retreat program that uses psilocybin (a substance being studied for anxiety and depression) to help people with anxiety and depression. This is for patients who have metastatic solid tumors (cancer that has spread from its original site) or incurable hematologic malignancies (blood cancers that cannot be cured). The main goal is to see how safe this treatment is and what side effects it might have over six months. We are looking for 18 participants between 18 and 85 years old. The study aims to see if psilocybin therapy can help relieve anxiety and distress by changing thought patterns that contribute to these feelings.
- Study design
- This is a Phase II interventional study, meaning it tests a specific treatment. It plans to enroll 18 participants.
- What's involved
- You would attend several virtual and in-person therapy sessions, receive psilocybin orally on one day, and have follow-up visits for up to 6 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants are followed up for 2 weeks, and then at 1, 2, 3, and 6 months after treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07336238
Group Retreat Psilocybin Therapy for the Treatment of Anxiety and Depression in Patients With Metastatic Solid Tumors or Incurable Hematologic Malignancies
Active, Not Recruiting
PHASE2Ages 18–85InterventionalTreatmentUniversity of WashingtonInvestigator-initiated
~18 participants
Updated 2026-07-31 on ClinicalTrials.gov
What's tested:PsychotherapyPsilocybinSurvey 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
Measured over Up to 6 months
Conditions
NCT07336238
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washingtonno site contact published
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Anthony Back, MD · PRINCIPAL_INVESTIGATOR · Fred Hutch/University of Washington Cancer Consortium
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Want this trial checked against your situation?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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 Hospital and Anxiety Depression Scale-Anxiety (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 phase 2a 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 who is able to verbally monitor participant-reported changes in their behavior and able to notify research staff of behavior changes that may require research staff assessment
Must provide a review of any antidepressant (such as selective serotonin reuptake inhibitor (\[SSRI)\], serotonin and norepinephrine reuptake inhibitor \[SNRI\]) use
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 highly effective birth control. Highly effective birth control is defined as birth control methods, alone or in combination, that result in a low failure rate (i.e., less than 1 percent per year, which does NOT include condoms or abstinence
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
Exclusion
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-Suicide Severity Rating Scale (C-SSRS) measurement of 'low risk' or no risk
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 UDP-glucuronosyltransferase (UGT) enzyme modulators
Baseline prolongation of QT/corrected QT (QTc) interval (e.g., demonstration on a 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 5-HTP, St John's Wort, and 'brain food' supplements
What this trial measures
- Incidence of adverse eventsUp to 6 months
Occurrence of any adverse event graded Severe on the Common Terminology Criteria for Adverse Events (CTCAE).