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

Part of paid clinical trials in Seattle, Washington.

Sponsor
University of Washington
Study ID
NCT07336238
Phase
PHASE2
Status
Recruiting
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Conditions

  • Anxiety
  • Depression
  • Hematopoietic and Lymphatic System Neoplasm
  • Metastatic Malignant Solid Neoplasm

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Psychotherapy — BEHAVIORAL
    Attend therapy sessions
  • Psilocybin — DRUG
    Given PO
  • Survey Administration — OTHER
    Ancillary studies

Study Details

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.

Key Dates

Start date
May 19, 2026
Status verified
Apr 2026
Primary completion
Jul 1, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (psilocybin therapy)
    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 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).

Primary Outcome Measure

Incidence of adverse events [ Time Frame: Up to 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Fred Hutch/University of Washington Cancer ConsortiumSeattleWashington98109
Anthony Back, MD
[email protected]
206-619-4367
Anthony Back, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Seattle, WA

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
Fred Hutch/University of Washington Cancer Consortium· Seattle, WA

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