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NCT05163496

Frontline Clinician Psilocybin Study

Completed Phase 3 Results posted Last updated 18 March 2025
What this trial tests

Phase 3 trial testing Psilocybin (Usona Institute) in Burnout, Caregiver in 30 participants. Completed in 30 June 2024.

Timeline
3 March 2022
Primary endpoint
30 December 2023
30 June 2024

Quick facts

Lead sponsorUniversity of Washington
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment30
Start date3 March 2022
Primary completion30 December 2023
Estimated completion30 June 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Washington

Who can join

18 and older, any sex, with Burnout, Caregiver or Burnout, Professional. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Montgomery-Asberg Depression Rating Scale Primary · 4-weeks post psilocybin-assisted psychotherapy

Assesses symptoms of depression (clinician-assessed): minimum score 0, max 60; higher score indicates more severe symptoms

GroupValue95% CI
Psilocybin Arm21.33± 7.84
Placebo9.33± 7.32
Montgomery-Asberg Depression Rating Scale Secondary · 24 weeks post-psilocybin in the randomized phase psilocybin arm

Assesses symptoms of depression (clinician-assessed): minimum score 0, max 60; higher score indicates more severe symptoms

GroupValue95% CI
Psilocybin Arm3.67± 4.48
PTSD Checklist for DSM-5 (PCL5) Secondary · 4 weeks post-psilocybin or placebo session

Assesses symptoms of post-traumatic stress disorder; minimum score 0, max 80; higher scores indicate more severe symptoms of PTSD

GroupValue95% CI
Psilocybin Arm16.67± 15.04
Placebo6.74± 10.69

Sponsor's own description

This study aims to investigate the effects of a single dose of psilocybin, delivered in the contextof pre- and post-dose psychotherapy, on symptoms of depression and burnout suffered by healthcare clinicians as a result of frontline work in the COVID pandemic.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Alleviating anxiety and taming trauma: Novel pharmacotherapeutics for anxiety disorders and posttraumatic stress disorder.
    Singewald N, Sartori SB, Reif A, Holmes A. · · 2023 · cited 40× · PMID 36623804 · DOI 10.1016/j.neuropharm.2023.109418
  2. Psilocybin Therapy for Clinicians With Symptoms of Depression From Frontline Care During the COVID-19 Pandemic: A Randomized Clinical Trial.
    Back AL, Freeman-Young TK, Morgan L, Sethi T, et al · · 2024 · cited 24× · PMID 39636638 · DOI 10.1001/jamanetworkopen.2024.49026
  3. Psilocybin Facilitates Fear Extinction: Importance of Dose, Context, and Serotonin Receptors.
    Woodburn SC, Levitt CM, Koester AM, Kwan AC. · · 2024 · cited 22× · PMID 39087917 · DOI 10.1021/acschemneuro.4c00279
  4. Psychedelic Use Among Psychiatric Medication Prescribers: Effects on Well-Being, Depression, Anxiety, and Associations with Patterns of Use, Reported Harms, and Transformative Mental States.
    Herrmann Z, Levin AW, Cole SP, Slabaugh S, et al · · 2023 · cited 3× · PMID 40046570 · DOI 10.1089/psymed.2023.0030
  5. Unraveling the Mysteries of Mental Illness With Psilocybin.
    Sotille R, Singh H, Weisman A, Vida T. · · 2022 · cited 2× · PMID 35769681 · DOI 10.7759/cureus.25414
  6. Reporting of side-effects in clinical trials of psilocybin-assisted psychotherapy for psychiatric conditions: systematic review.
    Marinis J, Clarke ST, Guerin AA, Guastella AJ, et al · · 2025 · cited 1× · PMID 41178084 · DOI 10.1192/bjo.2025.10847

Verify or expand the search:

Other trials of Psilocybin (Usona Institute)

Trials testing the same drug.

Other recruiting trials for Burnout, Caregiver

Currently open trials in the same condition.

Other University of Washington trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05163496.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing