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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-15

Study Completion Date

2021-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Acute Stress Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Retrospective, Open-label chart review

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sublingual Micro-Dose Ketamine

Ketamine micro-dose 37.5mg compounded sublingual daily administration

Group Type EXPERIMENTAL

Sublingual Micro-Dose Ketamine

Intervention Type DRUG

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

Interventions

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Sublingual Micro-Dose Ketamine

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

Intervention Type DRUG

Eligibility Criteria

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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 -

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes