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临床试验/NCT05384470
NCT05384470已完成2 期

Detecting Drugs of Abuse Via Exhaled Breath Samples Using Differential Mobility Spectrometry

Mclean Hospital1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2021年8月1日最近更新:
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
32
试验地点
1
主要终点
Breath/cannabinoids concentrations

研究概览

简要总结

This Phase II STTR program consists of two major goals within the overarching goal of developing and validating a proprietary device (BID2) for marijuana and opioid detection in breath samples.

详细描述

This study is intended to lead to the development and demonstration of a breathalyzer instrument capable of detecting and quantitatively measuring drugs (i.e. cannabinoids and opioids) in exhaled breath (EB). Prior work on the detection of these drugs in EB by means of liquid chromatography and mass spectrometry (LC/MS) demonstrated that these compounds can be quantitatively detected, but LC/MS is slow, expensive and requires highly skilled personnel to implement. What is needed is a simple and inexpensive method for rapidly measuring the amount of drugs in EB.

If such a method becomes available it can be used by law enforcement and in doctors' offices, hospital emergency rooms, ambulances and other government agencies, military bases and companies seeking to screen employees for drug abuse. Vox Biomedical proposes to develop a method for quantitatively detecting the presence of drugs in EB by means of Differential Mobility Spectrometry (DMS) developed at Draper Laboratories. DMS is a robust, datarich, ultra-trace, chemical detection technology that has been proven for numerous applications including air quality cabin monitoring on the International Space Station (ISS), chemical warfare agent detection, explosives detection, and drinking water analysis. Recently Draper has applied this device to breath analysis for the detection of lung diseases.

A clinical study is currently underway and initial results are promising. This project involves transferring this technology developed by Draper for lung infection detection to the detection of psychoactive drugs in exhaled breath. Phase I of the proposed program will investigate the DMS signatures of cannabinoids in the laboratory and defining the device's limits of detection. A small pilot study will also be performed to demonstrate feasibility for using breath analysis as a proxy for the concentration of cannabinoids in the blood.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

年龄范围
21 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Exhaled Breath Samples

Quantitative detection of marijuana, morphine or fentanyl through exhaled breath

干预措施: Marihuana (Drug)

Exhaled Breath Samples

Quantitative detection of marijuana, morphine or fentanyl through exhaled breath

干预措施: BID2 Instrument - breathalyzer (Device)

结局指标

主要结局

Breath/cannabinoids concentrations

时间窗: 1 year

Quantitatively measuring cannabinoids in exhaled breath

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Scott Lukas

Director, McLean Imaging Center and BPRL

Mclean Hospital

研究点 (1)

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