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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04769297

Enrollment

Registered

2021-02-24

Start date

2020-04-15

Completion date

2021-04-30

Last updated

2021-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Stress Disorder

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.

Interventions

DRUGSublingual Micro-Dose Ketamine

daily micro-dosing of frontline healthcare workers suffering from acute stress disorder due to the COVID-19 pandemic

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Retrospective, Open-label chart review

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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 -

Design outcomes

Primary

Measure	Time frame	Description
Patient self-reported outcome measure	up to 120 days	Perceived Stress Scale

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026