AzTrials
AzTrials

Hematopoietic and Lymphatic System NeoplasmPhase 1NCT06644170

A Second Psilocybin Group Therapy for the Treatment of Cancer-Related Anxiety in Partial Responders With Metastatic Cancer

A Phase 1 study testing Behavioral Intervention, Group Therapy and Psilocybin 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
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
Behavioral Intervention, Group Therapy and Psilocybin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited States
Study dates
19 Nov 2024to 30 Sep 2025
Phase
Phase 1
Are there results?
None posted in the registry

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

  • 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, OR who have experienced a recurrence in their symptoms of anxiety or depression since completing the 6 month follow-up
  • 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
Show all 23Show fewer
  • 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.)

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)
Show all 16Show fewer
  • 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

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 Study of a Second Psilocybin Group Retreat for Partial Responders With Anxiety Associated With Metastatic Cancer

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.

Read the 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.

Being tested
Behavioral Intervention, Group Therapy, 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.

  • Behavioral InterventionBehavioural

    Also called Psychedelic therapy

    Attend individual visits

  • Group TherapyBehavioural

    Attend group visits

  • PsilocybinDrug

    Given PO

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT06644170
Study groupRoleWhat they receive
Treatment (psilocybin, group therapy)ExperimentalPatients receive psilocybin 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.
Receives: Behavioral: Behavioral Intervention; Behavioral: Group Therapy; Drug: Psilocybin; Other: Questionnaire Administration

What is being measured

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

  1. Incidence of adverse events (AEs)

    AEs will be defined as any untoward medical occurrence in a clinical investigation subject administered a medicinal product. AEs will be graded in severity using mild, moderate and severe. Occurrence of any adverse event graded severe on the Common Terminology Criteria for Adverse Events patient-reported questionnaires. Descriptive statistics will be used to analyze all adverse events, and in particular severe adverse events.

    Measured: At time of first exposure up to the date of the last questionnaire at 24 weeks

Secondary outcomes (1)

  1. Change in anxiety and depression

    Changes will be measured using the Hospital Anxiety and Depression Scale. For each group size, the "effect size" of change will be estimated, where effect size is defined as the mean change divided by the standard deviation of change. Assessment of anxiety and depression will be descriptive.

    Measured: At day -14 up to day 28

Timeline

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

  1. First posted16 Oct 2024
  2. Study start19 Nov 2024
  3. Primary completion30 Sep 2025
  4. Study completion30 Sep 2025

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06644170
Sponsor's protocol ID
RG1124860
Other IDs
NCI-2024-08058, 20619
Status last verified
Oct 2025
First submitted
11 Oct 2024
Last updated
14 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Behavioral Intervention, Group Therapy and Psilocybin 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 23 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: finished, as of the sponsor's last update on 14 Oct 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 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.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 (AEs) (time frame: At time of first exposure up to the date of the last questionnaire at 24 weeks). 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 NCT06644170.

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 14 Oct 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in