NCT04769297

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Limbic Medical · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Acute Stress Disorder

Interventions

Type	Name	Description
DRUG	Sublingual Micro-Dose Ketamine	daily micro-dosing of frontline healthcare workers suffering from acute stress disorder due to the COVID-19 pandemic

Timeline

• Start date: 2020-04-15
• Primary completion: 2021-04-01
• Completion: 2021-04-01
• First posted: 2021-02-24
• Last updated: 2021-02-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study