- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Timara Freeman-Young, PA-C
- Phone Number: (360) 218-4385
- Email: questions@frontlineclinicianstudy.org
Study Contact Backup
- Name: Jason Caucutt
- Phone Number: (206) 353-8069
- Email: jcaucutt@uw.edu
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98195
- University of Washington
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Psilocybin arm
psychedelic assisted psychotherapy + 25mg psilocybin
|
PAP + psilocybin 25 mg
Other Names:
|
Active Comparator: Placebo
Psychedelic assisted psychotherapy + 250mg niacin
|
PAP + niacin 250mg
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Montgomery-Asberg Depression Rating Scale
Time Frame: 4-weeks post psilocybin-assisted psychotherapy
|
Assesses symptoms of depression (clinician-assessed): minimum score 0, max 60; higher score indicates more severe symptoms
|
4-weeks post psilocybin-assisted psychotherapy
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Montgomery-Asberg Depression Rating Scale
Time Frame: 1, 8, 12, 24 weeks post-psilocybin-assisted psychotherapy
|
Assesses symptoms of depression (clinician-assessed): minimum score 0, max 60; higher score indicates more severe symptoms
|
1, 8, 12, 24 weeks post-psilocybin-assisted psychotherapy
|
Stanford Fulfillment Index
Time Frame: 1,4,8,12,24 -weeks post psilocybin-assisted psychotherapy
|
Assesses professional burnout in 3 components that are scored separately (professional fulfillment, interpersonal disengagement, work exhaustion)
|
1,4,8,12,24 -weeks post psilocybin-assisted psychotherapy
|
PTSD Checklist for DSM-5 (PCL5)
Time Frame: 1, 4, 8, 12, 24-weeks post-psilocybin-assisted psychotherapy
|
Assesses symptoms of post-traumatic stress disorder; minimum score 0, max 80; higher scores indicate more severe symptoms of PTSD
|
1, 4, 8, 12, 24-weeks post-psilocybin-assisted psychotherapy
|
Moral injury symptom scale
Time Frame: 4, 24 weeks post-psilocybin-assisted psychotherapy
|
Assesses symptoms of moral injury: minimum score 10, max 100; higher score indicates more severe symptoms
|
4, 24 weeks post-psilocybin-assisted psychotherapy
|
Beck Depression Index
Time Frame: 1, 4, 8, 12, 24-weeks post-psilocybin-assisted psychotherapy
|
Assess self-reported symptoms of depression: minimum score 0, max 63; higher score indicates more severe symptoms of depression
|
1, 4, 8, 12, 24-weeks post-psilocybin-assisted psychotherapy
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anthony Back, MD, University of Washington
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Stress, Psychological
- Occupational Stress
- Occupational Diseases
- Trauma and Stressor Related Disorders
- Depression
- Burnout, Professional
- Burnout, Psychological
- Stress Disorders, Traumatic
- Stress Disorders, Post-Traumatic
- Caregiver Burden
- Physiological Effects of Drugs
- Psychotropic Drugs
- Hallucinogens
- Psilocybin
Other Study ID Numbers
- STUDY00013891
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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