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

Sponsor
Limbic Medical (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04769297
Collaborator
Enovex Pharmacy (Other)
30
Enrollment
1
Location
1
Arm
11.5
Anticipated Duration (Months)
2.6
Patients Per Site Per Month

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 DiseaseIntervention/TreatmentPhase
  • Drug: Sublingual Micro-Dose Ketamine
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

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Retrospective, Open-label chart reviewRetrospective, Open-label chart review
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Micro-Dose, Macro-Impact: Leveraging Psychedelics in Frontline Healthcare Workers During the COVID-19 Pandemic
Actual Study Start Date :
Apr 15, 2020
Anticipated Primary Completion Date :
Apr 1, 2021
Anticipated Study Completion Date :
Apr 1, 2021

Arms and Interventions

ArmIntervention/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

  1. Patient self-reported outcome measure [up to 120 days]

    Perceived Stress Scale

  2. 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

  3. Patient self-reported outcome measure [up to 120 days]

    PCL-5 (PTSD checklist for DSM-5)

  4. Patient self-reported outcome measure [up to 120 days]

    Physical Health- NIH PROMIS Global

  5. Patient self-reported outcome measure [up to 120 days]

    Mental Health- NIH PROMIS Global

  6. Patient self-reported outcome measure [up to 120 days]

    Health Perception and Social Roles

  7. Patient self-reported outcome measure [up to 120 days]

    Doctor's Note

  8. Patient self-reported outcome measure [up to 120 days]

    NIH PROMIS CAT- Depression

  9. Patient self-reported outcome measure [up to 120 days]

    NIH PROMIS CAT Neuro-QOL-Anxiety

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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 -

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Limbic MedicalToluca LakeCaliforniaUnited States91602

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.
Responsible Party:
Limbic Medical
ClinicalTrials.gov Identifier:
NCT04769297
Other Study ID Numbers:
  • LM-LDK-001
First Posted:
Feb 24, 2021
Last Update Posted:
Feb 24, 2021
Last Verified:
Feb 1, 2021
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 24, 2021