Assessing Dose Taken in Opioid Use Disordered Patients With an Electrochemical Sensor
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 45
- 主要终点
- Sensitivity of detection of methadone levels in Interstitial Fluid using an electrochemical sensor
研究概览
简要总结
CARI Health aims to develop a methadone dose taken sensor that provides real-time data on interstitial fluid (ISF) levels that could be used as a methadone adherence monitor for daily doses. Use of such a monitor would allow for the physician, counselor, patient, and family member to remotely verify that a physician prescribed dose has been taken. Such a verification system can allow methadone clinics greater flexibility in the provision of take-home doses and thus retain more patients in the clinic.
详细描述
Three specific phases and 9 aims are proposed for first-in-human studies of a remote medication monitor for dose taken in patients taking methadone for opiate use disorder.
Phase 1 detection over 3-6 hours (N=10)
Aim 1: Detect methadone and one or more of its metabolites in interstitial fluid (ISF) with differential pulse voltammetry (DPV) Aim 2: Correlate in vitro blood-based LC-MS and DPV Scans with Intradermal Microneedle based DPV Scans Aim 3: Accurately identify that a dose of methadone has been taken Aim 4: Determine the frequency and severity of any adverse events up to 6 hours.
Phase 2 detection over 12 hours (N=15)
Aim 5. Quantitate methadone and one or more of its metabolites in ISF with DPV over 12 hrs.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
3 Days
Microneedle electrode array placed into dermis for up to 3 days. DPV Scans performed at a frequency of 1-20 per hour.
干预措施: Daily Methadone Dose (Drug)
3-6 HRS
Microneedle electrode array placed into dermis for up to 6 hours. DPV Scans performed at a frequency of 1-20 per hour.
干预措施: Remote Medication Monitor (RMM) - Prototype (Device)
3-6 HRS
Microneedle electrode array placed into dermis for up to 6 hours. DPV Scans performed at a frequency of 1-20 per hour.
干预措施: Daily Methadone Dose (Drug)
12 HRS
Microneedle electrode array placed into dermis for up to 12 hrs. DPV Scans performed at a frequency of 1-20 per hour.
干预措施: Remote Medication Monitor (RMM) - Prototype (Device)
12 HRS
Microneedle electrode array placed into dermis for up to 12 hrs. DPV Scans performed at a frequency of 1-20 per hour.
干预措施: Daily Methadone Dose (Drug)
3 Days
Microneedle electrode array placed into dermis for up to 3 days. DPV Scans performed at a frequency of 1-20 per hour.
干预措施: Remote Medication Monitor (RMM) - Prototype (Device)
结局指标
主要结局
Sensitivity of detection of methadone levels in Interstitial Fluid using an electrochemical sensor
时间窗: from 3 hours to 3 days.
Sensitivity of Repeated measurements of methadone levels
Specificity of detection of methadone levels in Interstitial Fluid using an electrochemical sensor
时间窗: from 3 hours to 3 days.
Specificity of Repeated measurements of methadone levels
次要结局
- Correlation between Blood and ISF levels of Methadone and Methadone Metabolites assayed with Remote Medication Monitor(from 3 hours to 3 days)
- Correlation between Blood and ISF levels of Methadone and Methadone Metabolites assayed with Liquid Chromatography - Mass Spectroscopy (LC-MS)(from 3 hours to 3 days)
- Correlation between Liquid Chromatography - Mass Spectroscopy (LC-MS) and Differential Pulse Voltammetry (DPV)(from 3 hours to 3 days)