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

• ClinicalTrials.gov Identifier: NCT04769297
• Recruitment Status: Unknown
• First Posted: February 24, 2021
• Last Update Posted: February 24, 2021
• Sponsor: Limbic Medical
• Collaborator: Enovex Pharmacy
• Information provided by (Responsible Party): Limbic Medical

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 (Clinical Trial)
• Actual Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Retrospective, 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: April 15, 2020
• Estimated Primary Completion Date: April 2021
• Estimated Study Completion Date: April 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 [ Time Frame: up to 120 days ]
   Perceived Stress Scale
2. Patient self-reported outcome measure [ Time Frame: 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 [ Time Frame: up to 120 days ]
   PCL-5 (PTSD checklist for DSM-5)
4. Patient self-reported outcome measure [ Time Frame: up to 120 days ]
   Physical Health- NIH PROMIS Global
5. Patient self-reported outcome measure [ Time Frame: up to 120 days ]
   Mental Health- NIH PROMIS Global
6. Patient self-reported outcome measure [ Time Frame: up to 120 days ]
   Health Perception and Social Roles
7. Patient self-reported outcome measure [ Time Frame: up to 120 days ]
   Doctor's Note
8. Patient self-reported outcome measure [ Time Frame: up to 120 days ]
   NIH PROMIS CAT- Depression
9. Patient self-reported outcome measure [ Time Frame: up to 120 days ]
   NIH PROMIS CAT Neuro-QOL-Anxiety

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

United States, California

Limbic Medical

Toluca Lake, California, United States, 91602

Sponsors and Collaborators

Limbic Medical

Enovex Pharmacy

Investigators

• Principal Investigator: Andre Atoian, MD; Limbic Medical

More Information

• Responsible Party: Limbic Medical
• ClinicalTrials.gov Identifier: NCT04769297
• Other Study ID Numbers: LM-LDK-001
• First Posted: February 24, 2021
• Last Update Posted: February 24, 2021
• Last Verified: February 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; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Ketamine; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Central Nervous System Depressants; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action