Status:
UNKNOWN
Micro-Dose, Macro-Impact: Leveraging Psychedelics in Frontline Healthcare Workers During the COVID-19 Pandemic
Lead Sponsor:
Limbic Medical
Collaborating Sponsors:
Enovex Pharmacy
Conditions:
Acute Stress Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 Pan...
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 s...
Eligibility Criteria
Inclusion
- 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
- 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 -
Key Trial Info
Start Date :
April 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04769297
Start Date
April 15 2020
End Date
April 1 2021
Last Update
February 24 2021
Active Locations (1)
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1
Limbic Medical
Toluca Lake, California, United States, 91602