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

Acute Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04769297
• Other study ID #: LM-LDK-001
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: April 15, 2020
• Est. completion date: April 2021

Study information

• Verified date: February 2021
• Source: Limbic Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: April 2021
• Est. primary completion date: April 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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 -

Related Conditions & MeSH terms

• Acute Stress Disorder
• Stress Disorders, Traumatic, Acute

Intervention

Drug:
• Sublingual Micro-Dose Ketamine
daily micro-dosing of frontline healthcare workers suffering from acute stress disorder due to the COVID-19 pandemic

Locations

Country	Name	City	State
United States	Limbic Medical	Toluca Lake	California

Sponsors (2)

Lead Sponsor	Collaborator
Limbic Medical	Enovex Pharmacy

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient self-reported outcome measure	Perceived Stress Scale	up to 120 days
Primary	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
Primary	Patient self-reported outcome measure	PCL-5 (PTSD checklist for DSM-5)	up to 120 days
Primary	Patient self-reported outcome measure	Physical Health- NIH PROMIS Global	up to 120 days
Primary	Patient self-reported outcome measure	Mental Health- NIH PROMIS Global	up to 120 days
Primary	Patient self-reported outcome measure	Health Perception and Social Roles	up to 120 days
Primary	Patient self-reported outcome measure	Doctor's Note	up to 120 days
Primary	Patient self-reported outcome measure	NIH PROMIS CAT- Depression	up to 120 days
Primary	Patient self-reported outcome measure	NIH PROMIS CAT Neuro-QOL-Anxiety	up to 120 days