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

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.

Study Overview

• Status: Unknown
• Conditions: Acute Stress Disorder
• Intervention / Treatment: Drug: Sublingual Micro-Dose Ketamine

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Toluca Lake, California, United States, 91602
      • Limbic Medical

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Limbic Medical
• Collaborators: Enovex Pharmacy
• Investigators: Principal Investigator: Andre Atoian, MD, Limbic Medical

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 15, 2020
• Primary Completion (ANTICIPATED): April 1, 2021
• Study Completion (ANTICIPATED): April 1, 2021

Study Registration Dates

• First Submitted: February 22, 2021
• First Submitted That Met QC Criteria: February 23, 2021
• First Posted (ACTUAL): February 24, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 24, 2021
• Last Update Submitted That Met QC Criteria: February 23, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; COVID-19; Stress Disorders, Traumatic, Acute; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Ketamine
• Other Study ID Numbers: LM-LDK-001

Drug and device information, study documents

• 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