Micro-Dose, Macro-Impact: Leveraging Psychedelics in Frontline Healthcare Workers During the COVID-19 Pandemic

Study Overview
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Brief Summary
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A retrospective chart review of an open-label trial of low-dose ketamine administered to front-line Healthcare workers who were identified as experiencing acute stress disorder due to the COVID-19 Pandemic.

Detailed Description
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An investigation of a novel, off-label use of an FDA approved drug (ketamine) in a low(micro) dose sublingual formulation of ketamine provided to front-line healthcare workers who were identified as suffering from acute stress disorder. The study was conducted completely virtually via real-time telemedicine for physician visits and via asynchronous interaction for outcomes data collection. Patients self-referred to the study via email outreach, and diagnosis was confirmed by medically validated screening assessments and study physician confirmation. Once treatment was initiated, patients were seen via live telemedicine every 40 days while treatment response/outcomes data was collected weekly and monthly. Patients were treated up to 120 days.

Official Title
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Micro-Dose, Macro-Impact: Leveraging Psychedelics in Frontline Healthcare Workers During the COVID-19 Pandemic

Conditions
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Acute Stress Disorder

Intervention / Treatment
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* Drug: Sublingual Micro-Dose Ketamine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Greater than 18 years of age Demonstrate capacity to consent to the study A Frontline Health Care Worker-defined as any EMS personnel (firefighter, EMT, flight nurse, etc.), or any hospital-based worker (particularly in the ED, ICU, or OR) such as an RN, MD/DO, or non-clinical support staff (EVS, etc.) Experiencing acute stress disorder as determined by clinically validated screening tools - Exclusion Criteria: Currently on prescription medications for psychiatric issues Currently pregnant or breastfeeding or actively trying to get pregnant History of seizure disorder, liver disease, or psychosis/mania Uncontrolled Hypertension Physician discretion: any condition deemed inappropriate that will increase the risk -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Retrospective, Open-label chart review
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sublingual Micro-Dose Ketamine<br>Ketamine micro-dose 37.5mg compounded sublingual daily administration | Drug: Sublingual Micro-Dose Ketamine<br>* daily micro-dosing of frontline healthcare workers suffering from acute stress disorder due to the COVID-19 pandemic<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient self-reported outcome measure | Perceived Stress Scale | up to 120 days | 
| Patient self-reported outcome measure | 15-Dimensional Health-Related Quality of Life Questionnaire 15-Dimensional Health-Related Quality of Life Questionnaire | up to 120 days | 
| Patient self-reported outcome measure | PCL-5 (PTSD checklist for DSM-5) | up to 120 days | 
| Patient self-reported outcome measure | Physical Health- NIH PROMIS Global | up to 120 days | 
| Patient self-reported outcome measure | Mental Health- NIH PROMIS Global | up to 120 days | 
| Patient self-reported outcome measure | Health Perception and Social Roles | up to 120 days | 
| Patient self-reported outcome measure | Doctor's Note | up to 120 days | 
| Patient self-reported outcome measure | NIH PROMIS CAT- Depression | up to 120 days | 
| Patient self-reported outcome measure | NIH PROMIS CAT Neuro-QOL-Anxiety | up to 120 days |