Naloxone Administration Via Auto-injection in Healthy Volunteers
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Detection of slowed breathing that triggers the successful actuation of the auto-injector
研究概览
简要总结
This study continues the work to develop a mobile breathing monitoring system to detect slowed breathing and overdose events caused by opioid use. This is a single-site feasibility study designed to test the mobile application with a commercially available drug delivery device called the SmartDose by West Pharmaceuticals, Inc. The SmartDose is a wearable self-injection device that can deliver a drug under the skin with a push of a button. Naloxone is a drug used to reverse the effects of opioid drugs in the body. This study will evaluate if the mobile application can wireless trigger the delivery of a small dose of naloxone to a healthy adult volunteer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Healthy male/female volunteers
- •>18 years
- •No allergy to naloxone or ingredients in its formulation
- •Ability to read and understand English
- •Written informed consent obtained from subject
- •Ability to comply with study requirements
排除标准
- •History of alcohol or substance abuse
- •History of unusual pain sensitivity, lack of sensitivity
- •History of chronic myofascial, inflammatory, neuropathic pain
- •Chronic use of medication known to interfere with naloxone
- •Pregnant women and nursing mothers
- •Presence of a condition or abnormality that in the opinion of the Principal Investigator would compromise subject safety or the quality of the data (e.g., persons with liver disease, renal insufficiency/failure)
- •Alcohol on the breath
结局指标
主要结局
Detection of slowed breathing that triggers the successful actuation of the auto-injector
时间窗: The participant breathes to 8 breaths per minute and the breath hold (15 - 30 seconds) triggers the auto-injector. This will take place over 1 -3 minutes.
Ability of the accelerometer-based system to detect slowed breathing and trigger the successful auto injection of medication
Plasma concentration of naloxone in blood samples
时间窗: Blood sampling at 3 and 8 minutes after the auto injector is triggered
The concentration of naloxone in the plasma is measured by blood at two time points
次要结局
未报告次要终点
研究者
Jacob Sunshine
Associate Professor, School of Medicine
University of Washington