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

Limbic Medical

Status and phase: Unknown; Phase 4

Conditions: Acute Stress Disorder

Treatments: Drug: Sublingual Micro-Dose Ketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT04769297

LM-LDK-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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 -

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 1 patient group

Sublingual Micro-Dose Ketamine

Experimental group

Description:

Ketamine micro-dose 37.5mg compounded sublingual daily administration

Treatment:

Drug: Sublingual Micro-Dose Ketamine