Micro-Dose, Macro-Impact: Leveraging Psychedelics in Frontline Healthcare Workers During the COVID-19 Pandemic
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Patient self-reported outcome measure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Greater than 18 years of age
- •Demonstrate capacity to consent to the study
- •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.)
- •Experiencing acute stress disorder as determined by clinically validated screening tools -
排除标准
- •Currently on prescription medications for psychiatric issues
- •Currently pregnant or breastfeeding or actively trying to get pregnant
- •History of seizure disorder, liver disease, or psychosis/mania
- •Uncontrolled Hypertension
- •Physician discretion: any condition deemed inappropriate that will increase the risk -
研究组 & 干预措施
Sublingual Micro-Dose Ketamine
Ketamine micro-dose 37.5mg compounded sublingual daily administration
干预措施: Sublingual Micro-Dose Ketamine (Drug)
结局指标
主要结局
Patient self-reported outcome measure
时间窗: up to 120 days
NIH PROMIS CAT Neuro-QOL-Anxiety
次要结局
未报告次要终点