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AnxietyPhase 2NCT07336238

Group Retreat Psilocybin Therapy for the Treatment of Anxiety and Depression in Patients With Metastatic Solid Tumors or Incurable Hematologic Malignancies

A Phase 2 study testing Psychotherapy, Psilocybin and Survey Administration in people with Anxiety and Depression, run by University of Washington at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This phase II trial tests the safety, side effects and how well group retreat psilocybin therapy works for the treatment of anxiety and depression in patients with solid tumors that have spread from where they first started (primary site) to other places in the body (metastatic) or with hematologic cancers for which… Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
Psychotherapy, Psilocybin and Survey Administration
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteUnited States
Study dates
19 May 2026to 1 May 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 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

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-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)
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  • 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

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 2a Study of Group Retreat Psilocybin Therapy for Cancer-Related Anxiety and Depression

This phase II trial tests the safety, side effects and how well group retreat psilocybin therapy works for the treatment of anxiety and depression in patients with solid tumors that have spread from where they first started (primary site) to other places in the body (metastatic) or with hematologic cancers for which no treatment is currently available (incurable). For patients with metastatic, incurable cancer, unrelieved anxiety and existential distress can cause profound suffering. Psilocybin therapy can relieve anxiety and existential distress by disrupting patterns of thinking that contribute to anxiety and depression. Psilocybin is a substance being studied in the treatment of anxiety or depression in patients with cancer. In this study, a pharmaceutical grade of psilocybin will be used that has been approved by the FDA for research, provided by Filament Health. Psilocybin acts on the brain by resetting the brain's activity and increasing connections between brain regions, particularly those involved in mood regulation and self-perception. In this study psilocybin is combined with structured discussions and reflections that enable patients to have new insights about their situation. In a prior study, group retreat psilocybin therapy was proven to be safe and this study tests a refined dosing regimen for symptoms of anxiety and depression in patients with metastatic solid tumors or incurable hematologic malignancies.

Read the detailed description

OUTLINE:

Patients attend group preparation therapy sessions on days -14 (virtual), -7 (virtual) and -1 (in person), and also attend an individual preparation therapy session on day -1 (in person). Patients receive psilocybin orally (PO) on day 0. Patients may receive an additional "booster" dose 60-90 minutes after the initial dose based on their subjective report combined with the physician's clinical judgement. Patients attend group integration therapy sessions on days 1 (in person), 8 (virtual), 15 (virtual), and 22 (virtual), and attend individual integration therapy sessions on days 1 (in person) and 8 (virtual).

After completion of study treatment, patients are followed up at 2 weeks and at 1, 2, 3, and 6 months.

Being tested
Psychotherapy, Psilocybin, Survey Administration
Medical subject headings
Anxiety Disorders, Depression, Neoplasm Metastasis

What participants receive

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

  • PsychotherapyBehavioural

    Also called therapy, talk therapy

    Attend therapy sessions

  • PsilocybinDrug

    Also called psilocybine

    Given PO

  • Survey AdministrationOther

    Ancillary studies

Study groups in NCT07336238
Study groupRoleWhat they receive
Treatment (psilocybin therapy)ExperimentalPatients attend group preparation therapy sessions on days -14 (virtual), -7 (virtual) and -1 (in person), and also attend an individual preparation therapy session on day -1 (in person). Patients receive psilocybin orally (PO) on day 0. Patients may receive an additional "booster" dose 60-90 minutes after the initial dose based on the physician's clinical judgement. Patients attend group integration therapy sessions on days 1 (in person), 8 (virtual), 15 (virtual), and 22 (virtual), and attend individual integration therapy sessions on days 1 (in person) and 8 (virtual).
Receives: Behavioral: Psychotherapy; Drug: Psilocybin; Other: Survey Administration

What is being measured

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

  1. Incidence of adverse events

    Occurrence of any adverse event graded Severe on the Common Terminology Criteria for Adverse Events (CTCAE).

    Measured: Up to 6 months

Secondary outcomes (1)

  1. Symptoms of Anxiety and Depression assessed via the Hospital Anxiety and Depression Scale (HADS): Change in Mean Total score

    Measured using the Hospital Anxiety and Depression Scale (HADS). Scores range from 0 (better) to 42 (worse).

    Measured: At day -14, 2 weeks, 1 month, 2 months, 3 months, 6 months

Timeline

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

  1. First posted13 Jan 2026
  2. Study start19 May 2026
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completion1 May 2027 (estimated)

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07336238
Sponsor's protocol ID
RG1126153
Other IDs
NCI-2025-09712, FHIRB0021135
Status last verified
Jul 2026
First submitted
9 Jan 2026
Last updated
29 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Psychotherapy, Psilocybin and Survey Administration in people with Anxiety and Depression, 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 16 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: under way, not looking for participants, as of the sponsor's last update on 29 Oct 2026. 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 phase mean?

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?

This study is still under way. Results are not available in the source record yet.

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?

Incidence of adverse events (time frame: Up to 6 months). 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 NCT07336238.

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 29 Oct 2026.

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