NCT05163496

Frontline Clinician Psilocybin Study

A Randomized, Placebo-controlled Trial of Psychedelic-assisted Psychotherapy With Single Dose Psilocybin for Frontline Clinicians Experiencing COVID-related Symptoms of Depression and Burnout

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Aim 1: To assess short- and longer-term effects of psilocybin-assisted psychotherapy (PAP) on symptoms of depression experienced by physicians and nurses with frontline work exposure in the COVID pandemic. Hypothesis 1.1: Compared to active placebo, PAP will result in short term improvement in symptoms of depression 1 day and 1 week after the psilocybin dose session. Hypothesis 1.2: Compared to active placebo, PAP will result in longer term improvement of symptoms of depression 4 weeks after the medication dosing session. The primary outcome will be a comparison between the psilocybin 25 mg vs control groups of a combination of depression symptoms measured at 4 weeks post medication dose session. 1.1.2. Aim 2: To explore short- and longer-term effects of psilocybin-assisted psychotherapy (PAP) on symptoms of burnout experienced by physicians and nurses with frontline work exposure in the COVID pandemic. Hypothesis 2.1: Compared to active placebo, PAP will result in short term improvement in symptoms of burnout 1 day and 1 week after the psilocybin dose session.

Conditions

• Burnout, Caregiver
• Burnout, Professional
• COVID-19
• Depression
• Post Traumatic Stress Disorder
• Moral Injury

Interventions

Type	Name	Description
DRUG	Psilocybin (Usona Institute)	PAP + psilocybin 25 mg
DRUG	Active placebo	PAP + niacin 250mg

Timeline

• Start date: 2022-03-03
• Primary completion: 2023-12-30
• Completion: 2024-06-30
• First posted: 2021-12-20
• Last updated: 2025-03-18
• Results posted: 2025-03-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study