Assessment of Methadone and Buprenorphine in Interstitial Fluid

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

11 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-14

Study Completion Date

2022-10-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Opioid Use Disorder

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Controls

Subjects not taking medications for opioid use disorder

Microneedle based interstitial fluid collection

Intervention Type PROCEDURE

Interstitial fluid will be collected from the skin using microneedles and suction.

Methadone

Subjects taking methadone for opioid use disorder

Microneedle based interstitial fluid collection

Intervention Type PROCEDURE

Interstitial fluid will be collected from the skin using microneedles and suction.

Buprenorphine

Subjects taking buprenorphine for opioid use disorder

Microneedle based interstitial fluid collection

Intervention Type PROCEDURE

Interstitial fluid will be collected from the skin using microneedles and suction.

Interventions

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Microneedle based interstitial fluid collection

Interstitial fluid will be collected from the skin using microneedles and suction.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age 18-65.
* 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

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes