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NCT07336238 · ClinicalTrials.gov registry record · Phase 2

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, sponsored by University of Washington.

Recruiting
Registry status
Phase 2
Development phase
18
Enrollment target

NCT07336238: Recruiting Phase 2 study, sponsored by University of Washington.

NCT07336238 is a Phase 2 study that is actively recruiting participants, run by University of Washington. The registered enrollment target is 18 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07336238, a Phase 2 study, is actively recruiting participants, sponsored by University of Washington.

RECRUITING
Registry status
Phase 2
Development phase
18 participants
Enrollment target

Study 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 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.

Primary Outcome

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

Interventions

  • BEHAVIORAL Psychotherapy
  • OTHER Survey Administration
  • DRUG Psilocybin

Trial Details

FieldValue
Enrollment Target 18 participants
Start Date 2026-05-19
Est. Completion 2027-12-31
Phase Phase 2
University of Washington

1,048 total trials

What NCT07336238 shows while recruiting

NCT07336238 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower).

The record links to 0 conditions, and to 3 interventions - of which Psychotherapy is the first listed.

NCT07336238 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT07336238 about?

NCT07336238 is a clinical study titled "Group Retreat Psilocybin Therapy for the Treatment of Anxiety and Depression in Patients With Metastatic Solid Tumors or Incurable Hematologic Malignancies". 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 ...

What is the current status of trial NCT07336238?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2026-05-19. Estimated completion is 2027-12-31.

What interventions are being tested in trial NCT07336238?

The interventions under investigation include: Psychotherapy (BEHAVIORAL), Survey Administration (OTHER), Psilocybin (DRUG).

Who is sponsoring clinical trial NCT07336238?

This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT07336238's enrollment target sits among peer trials

18 1898th of 2000 higher than 98 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT07336238, the US trial registry maintained by the National Library of Medicine. NCT07336238 (small enrollment · none site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.