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Burnout, CaregiverPhase 3NCT05163496

Frontline Clinician Psilocybin Study

A Phase 3 study testing Psilocybin (Usona Institute) in people with Burnout, Caregiver and Burnout, Professional, run by University of Washington at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Psilocybin (Usona Institute)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteUnited States
Study dates
3 Mar 2022to 30 Jun 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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.

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Washington

    Seattle, Washington, 98195

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Psilocybin (Usona Institute), Active placebo
Keywords
psilocybin, psychedelic assisted psychotherapy
Medical subject headings
Caregiver Burden, Burnout, Professional, COVID-19, Depression, Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Psilocybin (Usona Institute)Drug

    Also called Psychedelic-assisted psychotherapy (PAP)

    PAP + psilocybin 25 mg

  • Active placeboDrug

    Also called PAP with placebo

    PAP + niacin 250mg

Study groups in NCT05163496
Study groupRoleWhat they receive
Psilocybin armExperimentalpsychedelic assisted psychotherapy + 25mg psilocybin
Receives: Drug: Psilocybin (Usona Institute)
PlaceboActive comparatorPsychedelic assisted psychotherapy + 250mg niacin
Receives: Drug: Active placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Montgomery-Asberg Depression Rating Scale

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

    Measured: 4-weeks post psilocybin-assisted psychotherapy

Secondary outcomes (5)

  1. Montgomery-Asberg Depression Rating Scale

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

    Measured: 24 weeks post-psilocybin in the randomized phase psilocybin arm

  2. Stanford Fulfillment Index

    Assesses professional burnout in 3 components that are scored separately (professional fulfillment, interpersonal disengagement, work exhaustion)

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

  3. PTSD Checklist for DSM-5 (PCL5)

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

    Measured: 4 weeks post-psilocybin or placebo session

  4. Moral Injury Symptom Scale

    Assesses symptoms of moral injury: minimum score 10, max 100; higher score indicates more severe symptoms

    Measured: 4, 24 weeks post-psilocybin-assisted psychotherapy

  5. Beck Depression Index

    Assess self-reported symptoms of depression: minimum score 0, max 63; higher score indicates more severe symptoms of depression

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2021
  2. Study start3 Mar 2022
  3. Primary completion30 Dec 2023
  4. Study completion30 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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).
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05163496
Sponsor's protocol ID
STUDY00013891
Status last verified
Mar 2025
First submitted
6 Dec 2021
Last updated
18 Mar 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: IPD that underlie results in a publication

Publications

  • 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.

    PubMed 39636638

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Psilocybin (Usona Institute) in people with Burnout, Caregiver and Burnout, Professional, run by University of Washington at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Montgomery-Asberg Depression Rating Scale (time frame: 4-weeks post psilocybin-assisted psychotherapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05163496, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.

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