Group Retreat Psilocybin Therapy for Healthcare Clinicians With Loss of Meaning in Their Work and Symptoms of Depression

NCT07565909 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: STUDY00025289
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief Summary

In this single-arm Phase 2 study, the researchers are assessing the feasibility of the group retreat format for clinicians and explores different 'doses' of preparation. A sequential dose-escalation design is used. The study will recruit healthcare clinicians (physicians, nurses, nurse practitioners, physician assistants) aged 25-70 years currently in clinical practice with moderate or greater symptoms of depression and loss of meaning during the past 5 years. Each participant will be in a group cohort of 8, and 3 cohorts will be tested at each dose level. The objectives are safety, feasibility, mechanism testing, and outcomes.

Conditions

Depression; Anxiety

Keywords

psilocybin; group; retreat; preparation; healthcare workers

Outcome Measures

Primary Outcomes (1)

• Safety and Feasibility measures

  Adverse events

  1 week, 1 month, and 3 months after the retreat.

Secondary Outcomes (3)

• Mechanism testing measures

  3rd day of retreat

• Exploratory symptom measures

  1 week, 1 month, and 3 months after the retreat.

• Symptom measures

  1 week, 1 month, and 3 months after the retreat.

Study Arms (1)

Group Retreat Psilocybin Therapy

EXPERIMENTAL

In this non-randomized trial, the dose of psilocybin will be as follows: for participants not taking an antidepressant, the dose will be psilocybin 25 mg + optional booster 10 mg; for participants who are taking an antidepressant the dose will be psilocybin 35 mg + optional booster 10 mg,

Drug: Psilocybin

Interventions

Psilocybin DRUG

Includes preparation sessions, a single psilocybin session, and integration sessions

Also known as: Group Retreat Psilocybin Therapy

Group Retreat Psilocybin Therapy

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthcare clinicians (physicians, nurses, nurse practitioners, physician assistants) currently in clinical practice
• Age 25-70 years
• Loss of meaning single question "I used to find deep meaning in my work as a healthcare clinician, but during the past 5 years that sense of meaning has faded".
• PHQ-9 score ≥10 (moderate symptoms of depression)
• Ability to commit to all preparation sessions and retreat attendance
• English fluency sufficient for group participation
• Screening laboratory tests within acceptable limits, including liver function tests
• Negative urine drug screen for non-prescribed psychoactive medications.
• ECG with QTc \<450 ms
• Willing to taper and discontinue any supplements with serotonin-like properties, including but not limited to 5-HTP, St. John's Wort, and 'brain food' supplements.
• For participants of childbearing potential, agree to use to use highly effective contraception. Highly effective contraceptive methods are defined as those that, alone or in combination, result in a low failure rate (less than 1 percent per year), including but not limited to implants, IUDs, contraceptive injections, or contraceptive pills.

You may not qualify if:

• Personal or first-degree family history of psychotic disorder or bipolar I disorder
• Personal major depressive episode prior to entering healthcare as a professional
• Active suicidal ideation with intent or plan
• Unstable medical conditions
• Pregnancy or breastfeeding
• Hypertension with BP systolic \>150 or diastolic \> 90

Sponsors & Collaborators

• University of Washington: lead

MeSH Terms

Conditions

Depression; Anxiety Disorders

Interventions

Psilocybin

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines

Study Officials

• Anthony Back, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leslie Thorn

CONTACT

(206) 295-4425; lazthorn@uw.edu

Anthony Back, MD

CONTACT

206-619-4367; tonyback@uw.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor: Division of Hematology and Oncology

Model Details: 3 different dose levels of preparation will be tested, with 3 cohorts in each dose level.

Study Record Dates

• First Submitted: April 11, 2026
• First Posted: May 4, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: May 4, 2026

Record last verified: 2026-04