Assessment of Methadone Dose Taken
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- EMDP concentration in ISF before and after daily dose of methadone
研究概览
简要总结
Proof of concept: Pilot Study
A Pilot, proof of concept, observational study with a long-term goal to develop a minimally invasive wearable Remote Medication Monitor (RMM) that provides continuous, real-time data on methadone levels in interstitial fluid (ISF). An RMM could be used as a medication adherence monitor and would allow for the physician, counselor, patient, or family member to remotely verify that a physician-prescribed dose has been taken.
详细描述
The investigator will conduct a non-randomized, non-blinded, feasibility study at a single center in the United States. The study will include up to 20 subjects of an equal number of male and female adults (ages 18-70) who have a prescription for methadone for chronic pain. In Aim 1, the investigator will determine if an RMM can assess the status of taking a prescribed dose of methadone, using biosamples (i.e., ISF, blood) collected from subjects and tested in a laboratory setup. Biosample collections and pharmacokinetic monitoring will take up to 6 consecutive hours. By completing this aim, the investigator will determine if a physician is able to recognize the peak and trough of a methadone dose using ex vivo Continuous Monitor.
In Aim 2, the investigator will determine if an RMM can continuously assess the status of taking a prescribed dose of methadone over time, by inserting the intradermal microneedle sensing elements into the subjects' skin. Biosample collections (i.e., ISF, blood) and pharmacokinetic monitoring will occur over a 6-hour period. By completing this aim, the investigator will determine if a physician is able to recognize the pharmacokinetic profile of a taken dose of methadone. The physician will see a dosing curve display generated from intradermal microneedle sensing elements that are worn continuously on the skin. Completion of Aims 1-2 will require two separate visits.
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
- 否
入选标准
- •Age 18-70
- •A prescription for methadone for chronic pain at a dose of 10mg or more for at least one week.
- •Taking methadone as prescribed during the last 4 days before consent to participate in the study.
排除标准
- •Age <18 or >70
- •A condition preventing or complicating ISF collection
- •dermatological (skin) condition
- •immunodeficiency
- •recent blood donation
- •end stage renal disease
- •liver cirrhosis
- •congestive heart failure
- •bleeding diathesis
- •tuberculosis (TB)
- •Any active severe depression
- •suicidal ideation
- •mania symptoms
- •Pregnancy
- •Intending to become pregnant during the course of the study
- •Enrolled in a substance use disorder treatment program
- •Under a conservatorship.
研究组 & 干预措施
Visit 2
AIM 2 : Determine if an RMM can assess the status of taking a prescribed dose of methadone. To complete this aim, the peak and trough concentrations of a witnessed methadone dose will be assessed in ISF collected through the surface of the skin using existing ISF extraction methods and assessed outside the body via Lateral Flow Immunoassay for up to 6 hours. Methadone metabolites and protein binding factors may be assessed in the collected ISF samples using (LC-MS). We hypothesize that the methadone peak and trough levels as well as the metabolites in the blood samples will correlate with the levels of methadone in ISF.
The Investigators hypothesize that the methadone peak and trough levels as well as the metabolites in the blood samples will correlate with the levels of methadone in ISF.
干预措施: Measurement of Methadone in the Interstitial Fluid (ISF) before and after prescribed dose taken ex vivo (Diagnostic Test)
Visit 2
AIM 2 : Determine if an RMM can assess the status of taking a prescribed dose of methadone. To complete this aim, the peak and trough concentrations of a witnessed methadone dose will be assessed in ISF collected through the surface of the skin using existing ISF extraction methods and assessed outside the body via Lateral Flow Immunoassay for up to 6 hours. Methadone metabolites and protein binding factors may be assessed in the collected ISF samples using (LC-MS). We hypothesize that the methadone peak and trough levels as well as the metabolites in the blood samples will correlate with the levels of methadone in ISF.
The Investigators hypothesize that the methadone peak and trough levels as well as the metabolites in the blood samples will correlate with the levels of methadone in ISF.
干预措施: Measurement of Methadone in the Interstitial Fluid before and after prescribed dose taken in vivo (Drug)
Visit 2
AIM 2 : Determine if an RMM can assess the status of taking a prescribed dose of methadone. To complete this aim, the peak and trough concentrations of a witnessed methadone dose will be assessed in ISF collected through the surface of the skin using existing ISF extraction methods and assessed outside the body via Lateral Flow Immunoassay for up to 6 hours. Methadone metabolites and protein binding factors may be assessed in the collected ISF samples using (LC-MS). We hypothesize that the methadone peak and trough levels as well as the metabolites in the blood samples will correlate with the levels of methadone in ISF.
The Investigators hypothesize that the methadone peak and trough levels as well as the metabolites in the blood samples will correlate with the levels of methadone in ISF.
干预措施: ISF Extraction Device 2 (Device)
Visit 3
AIM 3: Determine if an RMM can continuously assess the status of taking a prescribed dose of methadone over time. To complete this aim, the pharmacokinetic profile of a witnessed methadone dose will be assessed in ISF continuously from the surface of the skin using the RMM for up to 12 hours (Aim 3a) and over 3 days (Aim 3b). Methadone metabolites will also be assessed over these three time points in the continuously collected ISF samples using LC-MS. The Investigators hypothesize that a clinician can recognize a dose taken and the methadone metabolites from the RMM generated measurements in the ISF.
干预措施: Measurement of Methadone in the Interstitial Fluid (ISF) before and after prescribed dose taken ex vivo (Diagnostic Test)
Visit 3
AIM 3: Determine if an RMM can continuously assess the status of taking a prescribed dose of methadone over time. To complete this aim, the pharmacokinetic profile of a witnessed methadone dose will be assessed in ISF continuously from the surface of the skin using the RMM for up to 12 hours (Aim 3a) and over 3 days (Aim 3b). Methadone metabolites will also be assessed over these three time points in the continuously collected ISF samples using LC-MS. The Investigators hypothesize that a clinician can recognize a dose taken and the methadone metabolites from the RMM generated measurements in the ISF.
干预措施: Measurement of Methadone in the Interstitial Fluid before and after prescribed dose taken in vivo (Drug)
Visit 3
AIM 3: Determine if an RMM can continuously assess the status of taking a prescribed dose of methadone over time. To complete this aim, the pharmacokinetic profile of a witnessed methadone dose will be assessed in ISF continuously from the surface of the skin using the RMM for up to 12 hours (Aim 3a) and over 3 days (Aim 3b). Methadone metabolites will also be assessed over these three time points in the continuously collected ISF samples using LC-MS. The Investigators hypothesize that a clinician can recognize a dose taken and the methadone metabolites from the RMM generated measurements in the ISF.
干预措施: ISF Extraction Device 2 (Device)
Visit 1
Aim 1: Characterize dermal interstitial fluid (ISF) in healthy adults with Liquid Chromatography-Mass Spectroscopy (LC-MS) based proteomics. To complete this aim, the dermal interstitial fluid will be extracted from the surface of the skin of healthy adults over a period up to 3 hours. The participants may also have continuous monitoring of their interstitial fluid using the RMM. We hypothesize that the protein content of ISF will be 50% the level of normal human serum levels and contain potential protein biomarkers of disease status.
干预措施: ISF Extraction Device 2 (Device)
结局指标
主要结局
EMDP concentration in ISF before and after daily dose of methadone
时间窗: 1 day
measure EMDP in ISF before and after daily dose of methadone
EMDP concentration in blood before and after daily dose of methadone
时间窗: 1 day
measure EMDP in blood by LC-MS before and after daily dose of methadone
LC-MS based Proteome analysis of dermal interstitial fluid in non opioid use disordered patients
时间窗: 1 day
Measure the dermal interstitial fluid proteome using LC-MS in subjects without opioid use disorder
Methadone Concentration in blood before and after a dose
时间窗: 1 day
measure blood for methadone with LC-MS before and after a daily dose
Pearson Correlation between DPV and LC-MS ISF EDDP
时间窗: 2 days
measure ISF for EDDP by LC-MS and DPV and determine Pearson correlation
EDDP concentration in blood before and after daily dose of methadone
时间窗: 1 day
measure blood for EDDP by LC-MS before and after daily dose of methadone
Methadone Concentration in ISF before and after a dose
时间窗: 1 day
measure dermal interstitial fluid with LC-MS for methadone before and after a daily dose
Pearson Correlation of Methadone between ISF and Blood
时间窗: 2 days
measure blood and ISF methadone with LC-MS and determine pearson correlation
Pearson Correlation of Methadone to Metabolite Ratio ( MMR ) between ISF and Blood using LC-MS
时间窗: 2 days
Calculate methadone to EDDP ratio of ISF and Blood and determine Pearson Correlation using LC-MS
Concentration of Methadone in ISF with LC-MS versus Electrochemical Assay
时间窗: 2 days
measure ISF with two procedures (Liquid Chromatography - Mass Spectroscopy and Differential Pulse Voltammetry.
Concentration of Methadone in blood with LC-MS versus Electrochemical Assay
时间窗: 2 days
measure blood with two procedures (Liquid Chromatography - Mass Spectroscopy and Differential Pulse Voltammetry.
Pearson Correlation between DPV and LC-MS ISF Methadone
时间窗: 2 days
measure ISF for methadone by LC-MS and DPV and determine Pearson correlation
Pearson Correlation between DPV and LC-MS blood EDDP
时间窗: 2 days
measure blood for EDDP by LC-MS and DPV and determine Pearson correlation
EDDP concentration in ISF before and after daily dose of methadone
时间窗: 1 day
measure ISF for EDDP by LC-MS before and after daily dose of methadone
Pearson Correlation of Methadone to Metabolite Ratio ( MMR ) between ISF and Blood using DPV
时间窗: 2 days
Calculate methadone to EDDP ratio of ISF and Blood and determine Pearson Correlation using DPV
次要结局
未报告次要终点