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

Phase 4

• Conditions: Acute Stress Disorder
• Interventions: Drug: Sublingual Micro-Dose Ketamine

• Registration Number: NCT04769297
• Lead Sponsor: Limbic Medical

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.

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 Timeline

• Study Start: 2020-04-15
• Status Verified: 2021-02
• Study First Submitted: 2021-02-22
• Study First Submitted QC: 2021-02-23
• Last Update Submitted: 2021-02-23
• Study First Posted: 2021-02-24
• Last Update Posted: 2021-02-24
• Primary Completion: 2021-04
• Study Completion: 2021-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sublingual Micro-Dose Ketamine	Sublingual Micro-Dose Ketamine	Ketamine micro-dose 37.5mg compounded sublingual daily administration

Primary Outcome Measures

Name	Time	Method
Patient self-reported outcome measure	up to 120 days	NIH PROMIS CAT Neuro-QOL-Anxiety

Trial Locations

Locations (1)

Limbic Medical; 🇺🇸 Toluca Lake, California, United States