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

Ketamine Psychedelics

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.

Intervention / Treatment

Retrospective, Open-label chart review
  • Sublingual Micro-Dose Ketamine (DRUG)
    daily micro-dosing of frontline healthcare workers suffering from acute stress disorder due to the COVID-19 pandemic

Condition or Disease

  • Acute Stress Disorder

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Unknown status
    Study results: No Results Available
    Enrollment: 30 (ACTUAL)
    Allocation: N/A
    Primary Purpose: Treatment

    Masking

    Clinical Trial Dates

    Start date: Apr 15, 2020 ACTUAL
    Primary Completion: Apr 01, 2021 ESTIMATED
    Completion Date: Apr 01, 2021 ESTIMATED
    Study First Posted: Feb 24, 2021 ACTUAL
    Last Updated: Feb 23, 2021

    Sponsors / Collaborators

    Lead Sponsor: N/A
    Lead sponsor is responsible party
    Responsible Party: N/A

    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.

    Participant Groups

    • Ketamine micro-dose 37.5mg compounded sublingual daily administration

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

    1. Greater than 18 years of age
    2. Demonstrate capacity to consent to the study
    3. 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.)
    4. Experiencing acute stress disorder as determined by clinically validated screening tools -

    Exclusion Criteria:

    1. Currently on prescription medications for psychiatric issues
    2. Currently pregnant or breastfeeding or actively trying to get pregnant
    3. History of seizure disorder, liver disease, or psychosis/mania
    4. Uncontrolled Hypertension
    5. Physician discretion: any condition deemed inappropriate that will increase the risk -

    Primary Outcomes

    • Perceived Stress Scale

    • 15-Dimensional Health-Related Quality of Life Questionnaire 15-Dimensional Health-Related Quality of Life Questionnaire

    • PCL-5 (PTSD checklist for DSM-5)

    • Physical Health- NIH PROMIS Global

    • Mental Health- NIH PROMIS Global

    • Health Perception and Social Roles

    • Doctor's Note

    • NIH PROMIS CAT- Depression

    • NIH PROMIS CAT Neuro-QOL-Anxiety

    More Details

    NCT Number: NCT04769297
    Other IDs: LM-LDK-001
    Study URL: https://clinicaltrials.gov/study/NCT04769297
    Last updated: Sep 29, 2023