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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE February 22, 2021
First Posted Date  ICMJE February 24, 2021
Last Update Posted Date February 24, 2021
Actual Study Start Date  ICMJE April 15, 2020
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 23, 2021)
  • Patient self-reported outcome measure [ Time Frame: up to 120 days ]
    Perceived Stress Scale
  • 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
  • Patient self-reported outcome measure [ Time Frame: up to 120 days ]
    PCL-5 (PTSD checklist for DSM-5)
  • Patient self-reported outcome measure [ Time Frame: up to 120 days ]
    Physical Health- NIH PROMIS Global
  • Patient self-reported outcome measure [ Time Frame: up to 120 days ]
    Mental Health- NIH PROMIS Global
  • Patient self-reported outcome measure [ Time Frame: up to 120 days ]
    Health Perception and Social Roles
  • Patient self-reported outcome measure [ Time Frame: up to 120 days ]
    Doctor's Note
  • Patient self-reported outcome measure [ Time Frame: up to 120 days ]
    NIH PROMIS CAT- Depression
  • Patient self-reported outcome measure [ Time Frame: up to 120 days ]
    NIH PROMIS CAT Neuro-QOL-Anxiety
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Micro-Dose, Macro-Impact: Leveraging Psychedelics in Frontline Healthcare Workers During the COVID-19 Pandemic
Official Title  ICMJE Micro-Dose, Macro-Impact: Leveraging Psychedelics in Frontline Healthcare Workers During the COVID-19 Pandemic
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Retrospective, Open-label chart review
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Stress Disorder
Intervention  ICMJE Drug: Sublingual Micro-Dose Ketamine
daily micro-dosing of frontline healthcare workers suffering from acute stress disorder due to the COVID-19 pandemic
Study Arms  ICMJE Experimental: Sublingual Micro-Dose Ketamine
Ketamine micro-dose 37.5mg compounded sublingual daily administration
Intervention: Drug: Sublingual Micro-Dose Ketamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: February 23, 2021)
30
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2021
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 -
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04769297
Other Study ID Numbers  ICMJE LM-LDK-001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Limbic Medical
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Limbic Medical
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Enovex Pharmacy
Investigators  ICMJE
Principal Investigator: Andre Atoian, MD Limbic Medical
PRS Account Limbic Medical
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP