Micro-Dose, Macro-Impact: Leveraging Psychedelics in Frontline Healthcare Workers During the COVID-19 Pandemic
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Apr 2020
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 15, 2020
CompletedFirst Submitted
Initial submission to the registry
February 22, 2021
CompletedFirst Posted
Study publicly available on registry
February 24, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2021
CompletedFebruary 24, 2021
February 1, 2021
12 months
February 22, 2021
February 23, 2021
Conditions
Outcome Measures
Primary Outcomes (9)
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
Study Arms (1)
Sublingual Micro-Dose Ketamine
EXPERIMENTALKetamine micro-dose 37.5mg compounded sublingual daily administration
Interventions
daily micro-dosing of frontline healthcare workers suffering from acute stress disorder due to the COVID-19 pandemic
Eligibility Criteria
You may qualify if:
- 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 -
You may not qualify if:
- 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 -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Limbic Medicallead
- Enovex Pharmacycollaborator
Study Sites (1)
Limbic Medical
Toluca Lake, California, 91602, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andre Atoian, MD
Limbic Medical
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 22, 2021
First Posted
February 24, 2021
Study Start
April 15, 2020
Primary Completion
April 1, 2021
Study Completion
April 1, 2021
Last Updated
February 24, 2021
Record last verified: 2021-02