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临床试验/NCT03242161
NCT03242161进行中(未招募)1 期

Development of LabPatch-alcohol: A Wearable Biosensor for Detecting Alcohol in Interstitial Fluid

Mclean Hospital1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2018年1月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
8
试验地点
1
主要终点
Interstitial and Blood Alcohol Concentrations

研究概览

简要总结

This study is designed to test LabPatch-alcohol, a wearable, non-invasive biosensor Band-Aid like patch that is designed to detect real-time changes in interstitial alcohol concentrations in human subjects. The changes in interstitial alcohol concentrations will be compared to blood alcohol concentrations to determine the patch's validity against the gold standard.

详细描述

Nanotechnology has the potential to become a powerful tool in addiction medicine. The potential utility for passive, non-invasive wearable alcohol monitors is great and could play a major role in public safety as well as in both research, clinical, and treatment settings. Clinitech, LLC has developed LabPatch, an electronic bandage that continuously and imperceptibly samples interstitial fluid from the skin surface and measures relevant biomarkers in the fluid. The patch uses novel nanowire technology to sample the interstitial fluid from just underneath the skin and then uses an electrochemical reaction to measure either glucose or alcohol concentration. The participants' interstitial alcohol concentration (IAC) will be measured via LabPatch-alcohol at the same time points as blood samples so that a direct comparison can be made. Thus, the LabPatch-alcohol will be tested as the participant's BAC rises and falls through the legally intoxicated concentration (0.08%), and the goal is to match measures obtained via the prototype LabPatch-alcohol with whole blood alcohol concentrations. The LabPatch operational circuit lies on the underside of the bandage. The circuit surface is placed in contact with the skin by the application of the elastic adhesive bandage with a contact tension that provides modest pressure, as in the case of a conventional wound bandage. The temperature of the skin is measured electrically and the consistency of temperature is used to verify good contact and to monitor continued contact. The entire process takes 3-5 seconds to collect the sample, a pause for 1 sec and then 3 additional seconds to conduct the analysis.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Device Feasibility
盲法
None

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

  • Subject is capable of understanding and complying with the protocol
  • Good physical and mental health (normal physical exam, ECG, blood and urine chemistries, including absences of history or laboratory evidence of diabetes)
  • Body Mass Index between 18-30, inclusive
  • Age 21-50 years (age will be verified by driver's license or other valid form of identification)
  • Have used alcohol, on average, between 5-15 drinks per week over the past 6 months.
  • Have a stable living situation with current postal address

排除标准

  • Meets criteria for current alcohol or substance use disorders (Past alcohol or substance use disorders greater than 3 years ago is acceptable)
  • Concurrent diagnosis of Axis I disorder
  • bMaintained on an antipsychotic or antidepressant medication; taking prescription medications except certain short-term anti-fungal agents and some tropical creams for dermal conditions
  • Heavy alcohol drinkers (greater than 15 drinks per week)
  • Tobacco use greater than 5 cigarettes per day
  • History of major head trauma resulting in cognitive impairment or history of seizure disorder
  • Heavy caffeine use (greater than 500 mg on a regular daily basis)
  • Subject has active hepatitis and/or aspartate aminotransferase (AST), alanine aminotransferase (ALT) > 3x the upper limit of normal
  • For female volunteers, a positive pregnancy test

研究组 & 干预措施

LabPatch-alcohol

Experimental

All subjects will be administered alcohol and then monitored by a non-invasive alcohol sensor

干预措施: LabPatch-alcohol (Diagnostic Test)

结局指标

主要结局

Interstitial and Blood Alcohol Concentrations

时间窗: Both samples will be collected at baseline and at 2.5 to 5 minute intervals for up to 2.5 hrs after a 0.9 g/kg dose of alcohol.

Interstitial (from the skin surface) alcohol concentrations will be obtained via the LabPatch band-aid while at the same time blood samples will be collected in an attempt to correlate the two. The LabPatch-alcohol is a completely noninvasive device and the goal is to determine is precision against the gold standard--blood alcohol concentrations.

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

Mclean Hospital

研究点 (1)

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