Micro-Dose, Macro-Impact: Leveraging Psychedelics in Frontline Healthcare Workers During the COVID-19 Pandemic
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
Detailed Description
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Sublingual Micro-Dose Ketamine Ketamine micro-dose 37.5mg compounded sublingual daily administration |
Drug: Sublingual Micro-Dose Ketamine
daily micro-dosing of frontline healthcare workers suffering from acute stress disorder due to the COVID-19 pandemic
|
Outcome Measures
Primary Outcome Measures
- Patient self-reported outcome measure [up to 120 days]
Perceived Stress Scale
- Patient self-reported outcome measure [up to 120 days]
15-Dimensional Health-Related Quality of Life Questionnaire 15-Dimensional Health-Related Quality of Life Questionnaire
- Patient self-reported outcome measure [up to 120 days]
PCL-5 (PTSD checklist for DSM-5)
- Patient self-reported outcome measure [up to 120 days]
Physical Health- NIH PROMIS Global
- Patient self-reported outcome measure [up to 120 days]
Mental Health- NIH PROMIS Global
- Patient self-reported outcome measure [up to 120 days]
Health Perception and Social Roles
- Patient self-reported outcome measure [up to 120 days]
Doctor's Note
- Patient self-reported outcome measure [up to 120 days]
NIH PROMIS CAT- Depression
- Patient self-reported outcome measure [up to 120 days]
NIH PROMIS CAT Neuro-QOL-Anxiety
Eligibility Criteria
Criteria
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:
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Currently on prescription medications for psychiatric issues
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Currently pregnant or breastfeeding or actively trying to get pregnant
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History of seizure disorder, liver disease, or psychosis/mania
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Uncontrolled Hypertension
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Physician discretion: any condition deemed inappropriate that will increase the risk -
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Limbic Medical | Toluca Lake | California | United States | 91602 |
Sponsors and Collaborators
- Limbic Medical
- Enovex Pharmacy
Investigators
- Principal Investigator: Andre Atoian, MD, Limbic Medical
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LM-LDK-001