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)
• Enrollment: 30
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 11.5
• Patients Per Site Per Month: 2.6

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
Acute Stress Disorder	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

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

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

	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.

• 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: COVID-19; Stress Disorders, Traumatic, Acute; Ketamine

Study Results

No Results Posted as of Feb 24, 2021