Clinical trial NCT05546229: Assessment of Methadone and Buprenorphine in Interstitial Fluid
Official title: Interstitial Fluid Collection Validation Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Opioid Use Disorder
Keywords: methadone
buprenorphine
interstitial fluid
Lead sponsor: Cari Health Inc.
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Drug Abuse (NIDA)
First posted: 2022-09-19
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients receiving medication assisted treatment for opioid use disorder and control subjects not receiving any treatment for this condition.

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Methadone Concentration in Plasma and Interstitial Fluid (ISF) Before and After Taking a Dose
timeFrame: 1 day
measure: Methadone Metabolite/ 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine ( EDDP ) Concentration in ISF and Plasma Before and After Taking a Dose of Methadone
timeFrame: 1 day
measure: Methadone and Its Metabolite/ EDDP Concentrations Using Liquid Chromatography Mass Spectroscopy (LC-MS) in Subjects Not Taking Methadone
timeFrame: 1 day
Secondary outcomes:
measure: Pearson Correlation for Methadone Levels in ISF and Blood
timeFrame: 1 day
measure: Pearson Correlation Coefficient for Methadone Metabolite / EDDP Levels in ISF and Blood
timeFrame: 1 day
measure: Buprenorphine Concentration in Plasma and ISF Before and After a Dose Taken
timeFrame: 1 day
Other outcomes:
Locations:
city: Lemon Grove
country: United States
facility: Synergy San Diego
state: California
Study officials:
affiliation: Synergy San Diego
name: Mohammad Bari, MD
role: PRINCIPAL_INVESTIGATOR
References: