NCT05546229

Assessment of Methadone and Buprenorphine in Interstitial Fluid

Interstitial Fluid Collection Validation Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 11 (actual)
• Sponsor: Cari Health Inc. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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

• Opioid Use Disorder

Interventions

Type	Name	Description
PROCEDURE	Microneedle based interstitial fluid collection	Interstitial fluid will be collected from the skin using microneedles and suction.

Timeline

• Start date: 2022-09-14
• Primary completion: 2022-10-31
• Completion: 2022-10-31
• First posted: 2022-09-19
• Last updated: 2023-06-28
• Results posted: 2023-06-28

Locations

1 site across 1 country: United States