Interstitial Fluid Collection Validation Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Methadone Metabolite/ 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine ( EDDP ) Concentration in ISF and Plasma Before and After Taking a Dose of Methadone
研究概览
简要总结
The purpose of this research is to determine if common medications for opioid use disorder (i.e., buprenorphine/naloxone, buprenorphine, methadone) and their metabolites (norbuprenorphine [a metabolite of buprenorphine], buprenorphine-3-glucuronide [B3G; a metabolite in buprenorphine], ethylidene dimethyl diphenyl pyrrolidine [EDDP; a metabolite of methadone]) can be detected in the dermal interstitial fluid (i.e., fluid extracted from the surface of the skin). Additional subjects who are not prescribed or taking any of these medications will be included in this study to act as a comparison group
详细描述
This pilot study is an exploratory feasibility study that aims to determine if common medications for opioid use disorder (OUD; i.e., buprenorphine, methadone) and their metabolites (i.e., norbuprenorphine [a metabolite of buprenorphine], buprenorphine-3-glucuronide [B3G; a metabolite in buprenorphine], ethylidene dimethyl diphenyl pyrrolidine [EDDP; a metabolite for methadone]), can be detected in dermal interstitial fluid (ISF). Microliter volumes of ISF from the surface of the skin will be collected from patients with a prescription for each these medications (buprenorphine n = 10; methadone n = 10) and controls (n=2) using a microneedle patch or minimally invasive microneedle array that may be used in conjunction with a standard vacuum pump. Levels of these medications and their metabolites will then be detected and quantitated in these samples using standard and well-established instrumental analysis for comparison to blood samples.
Aim 1: Detect and quantitate buprenorphine and norbuprenorphine in ISF collected from the surface of the skin using a minimally invasive microneedle array. ISF collected from the surface of the skin will be tested for buprenorphine (i.e., Suboxone®, Subutex®), norbuprenorphine (a metabolite of buprenorphine), and B3G (a metabolite of buprenorphine) using standard instrumental analysis.
Aim 2: Detect and quantitate methadone in ISF collected from the surface of the skin using a minimally invasive microneedle array. ISF collected from the surface of the skin will be tested for methadone and EDDP using standard instrumental analysis.
Aim 3: Establish correspondence between detected medication levels in ISF and blood. Medication levels for buprenorphine and methadone detected in the ISF will be compared to medication levels measured in blood samples for the purpose of understanding the correlation between the ISF and blood levels.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •A prescription for buprenorphine at dose ≥ 16 mg/4mg, a prescription for buprenorphine/naloxone at dose ≥ 16 mg/4mg, a prescription for methadone at dose ≥ 60mg, or part of the control group.
- •Taken buprenorphine, buprenorphine/naloxone, or methadone as prescribed in the last 7 days, or part of the control group
排除标准
- •A condition preventing or complicating ISF collection. Conditions may include dermatological (skin) condition, immunodeficiency, recent blood donation, anemia, cancer, congestive heart failure, HIV, Hepatitis C [HCV], or tuberculosis [TB].
- •Any active severe depression (e.g., suicidal ideation) or mania symptoms.
- •Lactation, pregnancy, or intending to become pregnant during the course of the study.
- •Alcohol use in the past 7 days.
- •Illicit substance use in past 7 days (e.g., heroin, methamphetamines).
- •Under a conservatorship.
结局指标
主要结局
Methadone Metabolite/ 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine ( EDDP ) Concentration in ISF and Plasma Before and After Taking a Dose of Methadone
时间窗: 1 day
Plasma and ISF collected from the surface of the skin will be tested for methadone metabolite /eddp using LC-MS analysis. Detection will be performed before and 3 hours after taking prescribed dose of methadone.
Methadone and Its Metabolite/ EDDP Concentrations Using Liquid Chromatography Mass Spectroscopy (LC-MS) in Subjects Not Taking Methadone
时间窗: 1 day
Plasma collected from subjects not taking methadone by venipuncture and ISF collected from the surface of the skin. Samples tested for methadone and methadone metabolite /eddp using Liquid Chromatography-Mass Spec (LC-MS) analysis .
Methadone Concentration in Plasma and Interstitial Fluid (ISF) Before and After Taking a Dose
时间窗: 1 day
ISF collected from the surface of the skin along with blood plasma by venipuncture will be tested for methadone using LC-MS analysis.
次要结局
- Pearson Correlation Coefficient for Methadone Metabolite / EDDP Levels in ISF and Blood(1 day)
- Buprenorphine Concentration in Plasma and ISF Before and After a Dose Taken(1 day)
- Pearson Correlation for Methadone Levels in ISF and Blood(1 day)