Clinical trial NCT04769297: Micro-Dose, Macro-Impact: Leveraging Psychedelics in Frontline Healthcare Workers During the COVID-19 Pandemic
Official title: Micro-Dose, Macro-Impact: Leveraging Psychedelics in Frontline Healthcare Workers During the COVID-19 Pandemic
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Stress Disorder
Lead sponsor: Limbic Medical
Sponsor class: OTHER
Collaborators: name: Enovex Pharmacy
First posted: 2021-02-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Retrospective, Open-label chart review
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 -

Primary outcomes:
measure: Patient self-reported outcome measure
timeFrame: up to 120 days
measure: Patient self-reported outcome measure
timeFrame: up to 120 days
measure: Patient self-reported outcome measure
timeFrame: up to 120 days
measure: Patient self-reported outcome measure
timeFrame: up to 120 days
measure: Patient self-reported outcome measure
timeFrame: up to 120 days
measure: Patient self-reported outcome measure
timeFrame: up to 120 days
measure: Patient self-reported outcome measure
timeFrame: up to 120 days
measure: Patient self-reported outcome measure
timeFrame: up to 120 days
measure: Patient self-reported outcome measure
timeFrame: up to 120 days
Secondary outcomes:
Other outcomes:
Locations:
city: Toluca Lake
country: United States
facility: Limbic Medical
state: California
Study officials:
affiliation: Limbic Medical
name: Andre Atoian, MD
role: PRINCIPAL_INVESTIGATOR
References: