Frontline Clinician Psilocybin Study
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1/Phase 2 |
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 Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Psilocybin arm psychedelic assisted psychotherapy + 25mg psilocybin |
Drug: Psilocybin (Usona Institute)
PAP + psilocybin 25 mg
Other Names:
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Active Comparator: Placebo Psychedelic assisted psychotherapy + 250mg niacin |
Drug: Active placebo
PAP + niacin 250mg
Other Names:
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Outcome Measures
Primary Outcome Measures
- Montgomery-Asberg Depression Rating Scale [4-weeks post psilocybin-assisted psychotherapy]
Assesses symptoms of depression (clinician-assessed): minimum score 0, max 60; higher score indicates more severe symptoms
Secondary Outcome Measures
- Montgomery-Asberg Depression Rating Scale [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
- Stanford Fulfillment Index [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)
- PTSD Checklist for DSM-5 (PCL5) [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
- Moral injury symptom scale [4, 24 weeks post-psilocybin-assisted psychotherapy]
Assesses symptoms of moral injury: minimum score 10, max 100; higher score indicates more severe symptoms
- Beck Depression Index [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
Eligibility Criteria
Criteria
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;
- Caring for patients who have died without family physically present due to COVID-19 precautions
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Have a Montgomery-Asberg Depression Rating Scale (MADRS) clinician-administered depression score >21, indicating moderately severe symptoms.
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Have had persistent symptoms despite at least one medication and/or therapy trial of standard care treatment for depression.
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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.
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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.
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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.
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Has been off selective serotonin inhibitors (SSRIs) for at least five half-lives of the drug plus 2 weeks.
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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
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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.
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If able to bear children, must have a negative pregnancy test at study entry.
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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:
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Personal or immediate family history of schizophrenia, bipolar affective disorder, delusion disorder, paranoid disorder, or schizoaffective disorder.
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Suicidal ideation with a Columbia Suicide Severity Rating Scale (C-SSRS) > 3
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Current substance abuse disorder (except in the case of mild alcohol use )
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Neuroleptic and SSRI medications that cannot be tapered and discontinued in conjunction with the participant's prescribing physician.
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Unstable neurological or medical condition; history of seizure, chronic/severe headaches.
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Positive urine pregnancy test at the time of screening
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Any unstable medical condition that my render study procedures unsafe.
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Any use of psychedelic drugs within the prior 12 months.
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Use of tramadol, due to the potential for serotonin syndrome with concomitant use of psilocybin.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | University of Washington | Seattle | Washington | United States | 98195 |
Sponsors and Collaborators
- University of Washington
Investigators
- Principal Investigator: Anthony Back, MD, University of Washington
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STUDY00013891