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Hematopoietic and Lymphatic System NeoplasmPhase 1/2NCT05847686

Psilocybin-Assisted Therapy for the Treatment of Cancer-Related Anxiety in Patients With Metastatic Cancer

A Phase 1/2 study testing Counseling, Psilocybin and Questionnaire Administration in people with Hematopoietic and Lymphatic System Neoplasm and Metastatic Malignant Solid Neoplasm, run by University of Washington at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This phase I/II trial tests the safety and side effects of psilocybin in combination with therapy for the treatment of patients with metastatic cancer and symptoms of anxiety and/or depression. Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
Counseling, Psilocybin and Questionnaire Administration
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
1 siteUnited States
Study dates
27 Jun 2023to 17 Oct 2024
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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 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 Anxiety and Depression Scale (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 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
  • Has been off selective serotonin inhibitors for five half-lives of the drug plus 2 weeks
  • 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 prn benzodiazepines is allowed but high dose chronic benzodiazepine use must be reviewed by the principal investigator [PI]. Use of as needed [prn] gabapentoids is allowed by high dose chronic gabapentoid use must be reviewed by the PI)
  • Must provide a contact (relative, spouse, close friend, or other caregiver; can be the same person) 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

Who cannot join

  • 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)
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  • Neuroleptic (including olanzapine, prochlorperazine, promethazine), and selective serotonin reuptake inhibitor (SSRI) medications that cannot be tapered and discontinued in conjunction with the participant's prescribing physician (although ondansetron can be used for nausea)
  • 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, LSD > 200 micrograms) within the prior 12 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 MOAI (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. The concurrent use of SSRI/serotonin-norepinephrine reuptake inhibitor (SNRI) meds is assumed to be contraindicated due to the potential to increase the risk of serotonin syndrome and/or to attenuate the binding of psilocin to the HT2A receptor
  • A marked baseline prolongation of QT/corrected QT (QTc) interval (e.g., demonstration on > 1 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Fred Hutch/University of Washington Cancer Consortium

    Seattle, Washington, 98109

Other trials in United States

About this study

Official title: A Phase 1/2 Study of a Group Model of Psilocybin-Assisted Therapy for Cancer-Related Anxiety in Patients With Metastatic Cancer

This phase I/II trial tests the safety and side effects of psilocybin in combination with therapy for the treatment of patients with metastatic cancer and symptoms of anxiety and/or depression. Psilocybin is a substance being studied in conjunction with therapy for the treatment of anxiety and depression in patients with cancer. In this study, the psilocybin being used is derived from the mushroom psilocybe cubensis using a patented process that results in a pharmaceutical grade version of psilocybin. Psilocybin acts by activating serotonin receptors on brain cells which can change perceptions and patterns of thinking in ways that may decrease anxiety.

Read the detailed description

OUTLINE:

Patients receive psilocybin orally (PO) and participate in group and individual therapy sessions on trial.

Being tested
Counseling, Psilocybin, Questionnaire Administration
Medical subject headings
Neoplasm Metastasis

What participants receive

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

  • CounselingOther

    Also called Counseling Intervention

    Participate in therapy visits

  • PsilocybinDrug

    Also called CY-39, Indocybin, psilocybine

    Given PO

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT05847686
Study groupRoleWhat they receive
Treatment (psilocybin, therapy)ExperimentalPatients receive psilocybin PO and participate in group and individual therapy sessions on trial.
Receives: Other: Counseling; Drug: Psilocybin; Other: Questionnaire Administration

What is being measured

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

  1. Number of Instances of Potentially Unattended Psilocybin-related Distress During Psilocybin Sessions.

    Defined as the occurrence of participant distress among study participants in the small group during the psilocybin administration session on Day 0 that requires 1:1 facilitator attention that cannot be met by the 4-person facilitation team. The size of small groups of different sizes will vary over the course of the study. Descriptive statistics will be used to analyze and will be tabulated on Day 0 after each group intervention. Backup facilitators will be available when this occurs.

    Measured: At psilocybin administration session on day 0

Secondary outcomes (1)

  1. Change in Measured Anxiety and Depression: Hospital Anxiety and Depression Scale (HADS)

    The Hospital Anxiety and Depression Scale (HADS) is a self-administered measure of depression and anxiety. The HADS is not a diagnostic tool, but can screen for anxiety and depression. The HADS has 14 items in total and asks about mood in the past week. Seven items assess depression and seven items assess anxiety. The HADS can be administered repeatedly without impacting on validity. Each item is rated on a 4-point scale and the total provides a score of 0 minimum up to 21 maximum. A higher score indicates higher distress.

    Measured: From 14 days before the psilocybin session to 28 days (4 weeks) after the psilocybin session

Timeline

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

  1. First posted8 May 2023
  2. Study start27 Jun 2023
  3. Primary completion8 Apr 2024
  4. Study completion17 Oct 2024

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05847686
Sponsor's protocol ID
RG1123316
Other IDs
NCI-2023-02948, FHIRB0020001
Status last verified
Oct 2025
First submitted
26 Apr 2023
Last updated
5 Nov 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Back A, Myers S, Guy J, Perez J, Lazar Thorn L, McGregor B. Evolving Guidelines for the Use of Touch During a Clinical Trial of Group Psilocybin-Assisted Therapy. Psychedelic Med (New Rochelle). 2024 Dec 2;2(4):187-191. doi: 10.1089/psymed.2023.0069. eCollection 2024 Dec.

    PubMed 40051480

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Counseling, Psilocybin and Questionnaire Administration in people with Hematopoietic and Lymphatic System Neoplasm and Metastatic Malignant Solid Neoplasm, run by University of Washington 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 21 inclusion and 14 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: finished, as of the sponsor's last update on 5 Nov 2025. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Yes. Results are posted in the registry (first posted 30 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Instances of Potentially Unattended Psilocybin-related Distress During Psilocybin Sessions. (time frame: At psilocybin administration session on day 0). 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 NCT05847686, which also lists 1 linked publication.

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 2025; AzTrials last refreshed its copy on 8 Nov 2026.

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