Frontline Clinician Psilocybin Study

NCT05163496 | Completed Phase 3 Results FDA Drug

• 1 other identifier: STUDY00013891
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

psilocybin; psychedelic assisted psychotherapy

Outcome Measures

Primary Outcomes (1)

• Montgomery-Asberg Depression Rating Scale

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

  4-weeks post psilocybin-assisted psychotherapy

Secondary Outcomes (5)

• Montgomery-Asberg Depression Rating Scale

  24 weeks post-psilocybin in the randomized phase psilocybin arm

• Stanford Fulfillment Index

  1,4,8,12,24 -weeks post psilocybin-assisted psychotherapy

• PTSD Checklist for DSM-5 (PCL5)

  4 weeks post-psilocybin or placebo session

• Moral Injury Symptom Scale

  4, 24 weeks post-psilocybin-assisted psychotherapy

• Beck Depression Index

  1, 4, 8, 12, 24-weeks post-psilocybin-assisted psychotherapy

Study Arms (2)

Psilocybin arm

EXPERIMENTAL

psychedelic assisted psychotherapy + 25mg psilocybin

Drug: Psilocybin (Usona Institute)

Placebo

ACTIVE COMPARATOR

Psychedelic assisted psychotherapy + 250mg niacin

Drug: Active placebo

Interventions

Psilocybin (Usona Institute) DRUG

PAP + psilocybin 25 mg

Also known as: Psychedelic-assisted psychotherapy (PAP)

Psilocybin arm

Active placebo DRUG

PAP + niacin 250mg

Also known as: PAP with placebo

Placebo

Eligibility Criteria

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

You may qualify if:

• Participants must be physicians or nurses with at least 1 month of frontline clinical experience during the COVID pandemic who rate at least 2 of 4 items from the COVID Exposure index as 'more than half the days' during their peak 2 week period of exposure: i. Caring for someone critically ill with COVID-19, or who became critically ill while you were involved; ii. Working longer hours than usual in order to provide assistance or care to individuals with COVID-19; iii. Witnessing or responding to a death related to COVID-19, or losing a patient you had been caring for to COVID-19; iv. Caring for patients who have died without family physically present due to COVID-19 precautions
• Have a Montgomery-Asberg Depression Rating Scale (MADRS) clinician-administered depression score \>21, indicating moderately severe symptoms.
• Have had persistent symptoms despite at least one medication and/or therapy trial of standard care treatment for depression.
• English speaking - able to understand the process of consent and the risk and benefits associated with the study, and able to give written informed consent.
• Must be willing to sign a medical release for the investigators to communicate directly with their therapist and doctors to confirm a medication and/or medical history. This is decided on a case-by-case basis upon the discretion of the PI.
• Must be driven home after the medication dosing session by a driver (which could be a friend, family, rideshare or taxi).
• Must provide at least one adult to have continuous contact with the participant, provide participant transportation, monitor changes in the participant's behavior, and notify research staff of behavior changes.
• Has been off selective serotonin inhibitors (SSRIs) for at least five half-lives of the drug plus 2 weeks.
• Must avoid taking any psychiatric medications or starting a new psychiatric medication during the study. Should participant's doctor recommend starting a new psychiatric medication, participant will be required to notify the study team and the subject would withdraw from the study
• Must provide a contact (relative, spouse, close friend or other caregiver) who is willing and able to be reached by the Clinical Investigators in the event of a participant becoming suicidal.
• If able to bear children, must have a negative pregnancy test at study entry.
• Are willing to commit to preparation sessions, medication dosing sessions, integration sessions, to complete evaluation instruments and commit to be contacted for all necessary telephone contacts.

You may not qualify if:

• Personal or immediate family history of schizophrenia, bipolar affective disorder, delusion disorder, paranoid disorder, or schizoaffective disorder.
• Suicidal ideation with a Columbia Suicide Severity Rating Scale (C-SSRS) \> 3
• Current substance abuse disorder (except in the case of mild alcohol use )
• Neuroleptic and SSRI medications that cannot be tapered and discontinued in conjunction with the participant's prescribing physician.
• Unstable neurological or medical condition; history of seizure, chronic/severe headaches.
• Positive urine pregnancy test at the time of screening
• Any unstable medical condition that my render study procedures unsafe.
• Any use of psychedelic drugs within the prior 12 months.
• Use of tramadol, due to the potential for serotonin syndrome with concomitant use of psilocybin.

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (1)

• Back AL, Freeman-Young TK, Morgan L, Sethi T, Baker KK, Myers S, McGregor BA, Harvey K, Tai M, Kollefrath A, Thomas BJ, Sorta D, Kaelen M, Kelmendi B, Gooley TA. Psilocybin Therapy for Clinicians With Symptoms of Depression From Frontline Care During the COVID-19 Pandemic: A Randomized Clinical Trial. JAMA Netw Open. 2024 Dec 2;7(12):e2449026. doi: 10.1001/jamanetworkopen.2024.49026.

  PMID: 39636638 DERIVED

MeSH Terms

Conditions

Caregiver Burden; Burnout, Professional; COVID-19; Depression; Stress Disorders, Post-Traumatic

Interventions

Psilocybin

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior; Occupational Stress; Occupational Diseases; Burnout, Psychological; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Anthony Back MD
• Organization: University of Washington

tonyback@uw.edu

2066194367

Study Officials

• Anthony Back, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigators, study therapists, and outcomes assessors will all be blinded in the randomized phase of the study. Participants will be unblinded after the primary outcome, and those receiving placebo will be eligible to receive open label psilocybin.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, School of Medicine

Model Details: This study tests a hypothesis that a single session of psilocybin (the 'medication dosing' session) in the context of pre- and post-dose psychotherapy will result in improvement of symptoms of depression and burnout measured 4 weeks post-dose. This study hypothesis will be tested in a single site, double-blind, randomized controlled design involving 30 clinician participants that will compare effects of a single 25mg oral dose of psilocybin to a 250 mg of niacin (active placebo). The primary outcome measurements will be collected 4 weeks after the psilocybin dose, after which the participant group assignment will be unblinded, and participants who received niacin will be offered the opportunity to have a second dose session with a 25 mg dose (with pre- and post-dose psychotherapy).

Study Record Dates

• First Submitted: December 6, 2021
• First Posted: December 20, 2021
• Study Start: March 3, 2022
• Primary Completion: December 30, 2023
• Study Completion: June 30, 2024
• Last Updated: March 18, 2025
• Results First Posted: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: We anticipate sharing these data starting with publication of study results and for at least 3 years.
• Access Criteria: To be determined.

Locations

US (1)