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

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ClinicalTrials.gov Identifier: NCT04769297
Recruitment Status : Active, not recruiting
First Posted : February 24, 2021
Last Update Posted : February 24, 2021
Sponsor:
Collaborator:
Enovex Pharmacy
Information provided by (Responsible Party):
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.

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.

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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

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

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




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



Information from the National Library of Medicine

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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 -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04769297


Locations
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United States, California
Limbic Medical
Toluca Lake, California, United States, 91602
Sponsors and Collaborators
Limbic Medical
Enovex Pharmacy
Investigators
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Principal Investigator: Andre Atoian, MD Limbic Medical
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Responsible Party: Limbic Medical
ClinicalTrials.gov Identifier: NCT04769297    
Other Study ID Numbers: LM-LDK-001
First Posted: February 24, 2021    Key Record Dates
Last Update Posted: February 24, 2021
Last Verified: February 2021

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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:
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Stress Disorders, Traumatic, Acute
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
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