Opioid Use Disorder
Conditions
Keywords
methadone, buprenorphine, interstitial fluid
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.
Interventions
PROCEDUREMicroneedle based interstitial fluid collection
Interstitial fluid will be collected from the skin using microneedles and suction.
Sponsors
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Cari Health Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Methadone Concentration in Plasma and Interstitial Fluid (ISF) Before and After Taking a Dose | 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. |
| Methadone Metabolite/ 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine ( EDDP ) Concentration in ISF and Plasma Before and After Taking a Dose of Methadone | 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 | 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 . |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pearson Correlation for Methadone Levels in ISF and Blood | 1 day | The Pearson correlation coefficient of blood and ISF methadone levels was calculated using the Least Squared Method from Microsoft Excel software. |
| Pearson Correlation Coefficient for Methadone Metabolite / EDDP Levels in ISF and Blood | 1 day | The Pearson correlation coefficient between the ISF and blood levels of EDDP were calculated using the Least Squared Method by Microsoft Excel software. |
| Buprenorphine Concentration in Plasma and ISF Before and After a Dose Taken | 1 day | Plasma collected by venipuncture and ISF collected from the surface of the skin will be tested for buprenorphine using LC-MS analysis before and after a dose of buprenorphine has been taken |
Countries
United States
Participant flow
Recruitment details
15 patients recruited. 4 patients not eligible do to screening results that resulted in exclusion based on documented exclusion criteria. 1 extra control recruited instead of expected 2 due to initial 2 controls both of the same sex and the desire to have at least one female and one male control
Participants by arm
| Arm | Count |
|---|---|
| Controls Subjects not taking medications for opioid use disorder
Microneedle based interstitial fluid collection: Interstitial fluid will be collected from the skin using microneedles and suction. | 3 |
| Methadone Subjects taking methadone for opioid use disorder
Microneedle based interstitial fluid collection: Interstitial fluid will be collected from the skin using microneedles and suction. | 6 |
| Buprenorphine Subjects taking buprenorphine for opioid use disorder
Microneedle based interstitial fluid collection: Interstitial fluid will be collected from the skin using microneedles and suction. | 2 |
| Total | 11 |
Baseline characteristics
| Characteristic | Methadone | Total | Controls | Buprenorphine |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 10 Participants | 3 Participants | 2 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — | — |
| Region of Enrollment United States | 6 participants | 11 participants | 3 participants | 2 participants |
| Sex: Female, Male Female | 2 Participants | 5 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 4 Participants | 6 Participants | 2 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 6 | 0 / 2 |
| other Total, other adverse events | 0 / 3 | 0 / 6 | 0 / 2 |
| serious Total, serious adverse events | 0 / 3 | 0 / 6 | 0 / 2 |
Outcome results
Primary
Methadone and Its Metabolite/ EDDP Concentrations Using Liquid Chromatography Mass Spectroscopy (LC-MS) in Subjects Not Taking Methadone
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 .
Time frame: 1 day
Population: Patients not taking methadone that met the inclusion and exclusion criteria of the study. Includes only control and buprenorphine (BUP) cohorts.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Plasma Level of Methadone Prior to Daily Dose of Methadone | Methadone and Its Metabolite/ EDDP Concentrations Using Liquid Chromatography Mass Spectroscopy (LC-MS) in Subjects Not Taking Methadone | Patient Bup 1 | 0 ng/ml |
| Plasma Level of Methadone Prior to Daily Dose of Methadone | Methadone and Its Metabolite/ EDDP Concentrations Using Liquid Chromatography Mass Spectroscopy (LC-MS) in Subjects Not Taking Methadone | Patient Control 2 | 0 ng/ml |
| Plasma Level of Methadone Prior to Daily Dose of Methadone | Methadone and Its Metabolite/ EDDP Concentrations Using Liquid Chromatography Mass Spectroscopy (LC-MS) in Subjects Not Taking Methadone | Patient Bup 2 | 0 ng/ml |
| Plasma Level of Methadone Prior to Daily Dose of Methadone | Methadone and Its Metabolite/ EDDP Concentrations Using Liquid Chromatography Mass Spectroscopy (LC-MS) in Subjects Not Taking Methadone | Patient Control 3 | 0 ng/ml |
| Plasma Level of Methadone Prior to Daily Dose of Methadone | Methadone and Its Metabolite/ EDDP Concentrations Using Liquid Chromatography Mass Spectroscopy (LC-MS) in Subjects Not Taking Methadone | Patient Control 1 | 0 ng/ml |
| Plasma Level of Methadone 3 Hours After Taking Daily Dose | Methadone and Its Metabolite/ EDDP Concentrations Using Liquid Chromatography Mass Spectroscopy (LC-MS) in Subjects Not Taking Methadone | Patient Control 3 | 0 ng/ml |
| Plasma Level of Methadone 3 Hours After Taking Daily Dose | Methadone and Its Metabolite/ EDDP Concentrations Using Liquid Chromatography Mass Spectroscopy (LC-MS) in Subjects Not Taking Methadone | Patient Bup 1 | 0 ng/ml |
| Plasma Level of Methadone 3 Hours After Taking Daily Dose | Methadone and Its Metabolite/ EDDP Concentrations Using Liquid Chromatography Mass Spectroscopy (LC-MS) in Subjects Not Taking Methadone | Patient Bup 2 | 0 ng/ml |
| Plasma Level of Methadone 3 Hours After Taking Daily Dose | Methadone and Its Metabolite/ EDDP Concentrations Using Liquid Chromatography Mass Spectroscopy (LC-MS) in Subjects Not Taking Methadone | Patient Control 2 | 0 ng/ml |
| Plasma Level of Methadone 3 Hours After Taking Daily Dose | Methadone and Its Metabolite/ EDDP Concentrations Using Liquid Chromatography Mass Spectroscopy (LC-MS) in Subjects Not Taking Methadone | Patient Control 1 | 0 ng/ml |
| Interstitial Fluid Level of Methadone Pre Dose | Methadone and Its Metabolite/ EDDP Concentrations Using Liquid Chromatography Mass Spectroscopy (LC-MS) in Subjects Not Taking Methadone | Patient Control 3 | 0 ng/ml |
| Interstitial Fluid Level of Methadone Pre Dose | Methadone and Its Metabolite/ EDDP Concentrations Using Liquid Chromatography Mass Spectroscopy (LC-MS) in Subjects Not Taking Methadone | Patient Control 1 | 0 ng/ml |
| Interstitial Fluid Level of Methadone Pre Dose | Methadone and Its Metabolite/ EDDP Concentrations Using Liquid Chromatography Mass Spectroscopy (LC-MS) in Subjects Not Taking Methadone | Patient Control 2 | 0 ng/ml |
| Interstitial Fluid Level of Methadone Pre Dose | Methadone and Its Metabolite/ EDDP Concentrations Using Liquid Chromatography Mass Spectroscopy (LC-MS) in Subjects Not Taking Methadone | Patient Bup 1 | 0 ng/ml |
| Interstitial Fluid Level of Methadone Pre Dose | Methadone and Its Metabolite/ EDDP Concentrations Using Liquid Chromatography Mass Spectroscopy (LC-MS) in Subjects Not Taking Methadone | Patient Bup 2 | 0 ng/ml |
| Interstitial Fluid Level of Methadone 3 Hours After Daily Methadone Dose | Methadone and Its Metabolite/ EDDP Concentrations Using Liquid Chromatography Mass Spectroscopy (LC-MS) in Subjects Not Taking Methadone | Patient Bup 1 | 0 ng/ml |
| Interstitial Fluid Level of Methadone 3 Hours After Daily Methadone Dose | Methadone and Its Metabolite/ EDDP Concentrations Using Liquid Chromatography Mass Spectroscopy (LC-MS) in Subjects Not Taking Methadone | Patient Control 2 | 0 ng/ml |
| Interstitial Fluid Level of Methadone 3 Hours After Daily Methadone Dose | Methadone and Its Metabolite/ EDDP Concentrations Using Liquid Chromatography Mass Spectroscopy (LC-MS) in Subjects Not Taking Methadone | Patient Control 1 | 0 ng/ml |
| Interstitial Fluid Level of Methadone 3 Hours After Daily Methadone Dose | Methadone and Its Metabolite/ EDDP Concentrations Using Liquid Chromatography Mass Spectroscopy (LC-MS) in Subjects Not Taking Methadone | Patient Control 3 | 0 ng/ml |
| Interstitial Fluid Level of Methadone 3 Hours After Daily Methadone Dose | Methadone and Its Metabolite/ EDDP Concentrations Using Liquid Chromatography Mass Spectroscopy (LC-MS) in Subjects Not Taking Methadone | Patient Bup 2 | 0 ng/ml |
Primary
Methadone Concentration in Plasma and Interstitial Fluid (ISF) Before and After Taking a Dose
ISF collected from the surface of the skin along with blood plasma by venipuncture will be tested for methadone using LC-MS analysis.
Time frame: 1 day
Population: Patients that met the inclusion and exclusion criteria of the study. Only the methadone taking cohort included in this measure. Data collected prior to daily dose of methadone and 3 Hours after taking daily dose of methadone.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Plasma Level of Methadone Prior to Daily Dose of Methadone | Methadone Concentration in Plasma and Interstitial Fluid (ISF) Before and After Taking a Dose | Participant A | 565 ng/ml |
| Plasma Level of Methadone Prior to Daily Dose of Methadone | Methadone Concentration in Plasma and Interstitial Fluid (ISF) Before and After Taking a Dose | Participant B | 240 ng/ml |
| Plasma Level of Methadone Prior to Daily Dose of Methadone | Methadone Concentration in Plasma and Interstitial Fluid (ISF) Before and After Taking a Dose | Participant C | 96 ng/ml |
| Plasma Level of Methadone Prior to Daily Dose of Methadone | Methadone Concentration in Plasma and Interstitial Fluid (ISF) Before and After Taking a Dose | Participant D | 330 ng/ml |
| Plasma Level of Methadone Prior to Daily Dose of Methadone | Methadone Concentration in Plasma and Interstitial Fluid (ISF) Before and After Taking a Dose | Participant E | 796 ng/ml |
| Plasma Level of Methadone Prior to Daily Dose of Methadone | Methadone Concentration in Plasma and Interstitial Fluid (ISF) Before and After Taking a Dose | Participant F | 207 ng/ml |
| Plasma Level of Methadone 3 Hours After Taking Daily Dose | Methadone Concentration in Plasma and Interstitial Fluid (ISF) Before and After Taking a Dose | Participant F | 382 ng/ml |
| Plasma Level of Methadone 3 Hours After Taking Daily Dose | Methadone Concentration in Plasma and Interstitial Fluid (ISF) Before and After Taking a Dose | Participant D | 526 ng/ml |
| Plasma Level of Methadone 3 Hours After Taking Daily Dose | Methadone Concentration in Plasma and Interstitial Fluid (ISF) Before and After Taking a Dose | Participant A | 640 ng/ml |
| Plasma Level of Methadone 3 Hours After Taking Daily Dose | Methadone Concentration in Plasma and Interstitial Fluid (ISF) Before and After Taking a Dose | Participant C | 353 ng/ml |
| Plasma Level of Methadone 3 Hours After Taking Daily Dose | Methadone Concentration in Plasma and Interstitial Fluid (ISF) Before and After Taking a Dose | Participant B | 441 ng/ml |
| Plasma Level of Methadone 3 Hours After Taking Daily Dose | Methadone Concentration in Plasma and Interstitial Fluid (ISF) Before and After Taking a Dose | Participant E | 831 ng/ml |
| Interstitial Fluid Level of Methadone Pre Dose | Methadone Concentration in Plasma and Interstitial Fluid (ISF) Before and After Taking a Dose | Participant B | 14319 ng/ml |
| Interstitial Fluid Level of Methadone Pre Dose | Methadone Concentration in Plasma and Interstitial Fluid (ISF) Before and After Taking a Dose | Participant C | 990 ng/ml |
| Interstitial Fluid Level of Methadone Pre Dose | Methadone Concentration in Plasma and Interstitial Fluid (ISF) Before and After Taking a Dose | Participant D | 1700 ng/ml |
| Interstitial Fluid Level of Methadone Pre Dose | Methadone Concentration in Plasma and Interstitial Fluid (ISF) Before and After Taking a Dose | Participant F | 420 ng/ml |
| Interstitial Fluid Level of Methadone Pre Dose | Methadone Concentration in Plasma and Interstitial Fluid (ISF) Before and After Taking a Dose | Participant E | 4300 ng/ml |
| Interstitial Fluid Level of Methadone Pre Dose | Methadone Concentration in Plasma and Interstitial Fluid (ISF) Before and After Taking a Dose | Participant A | 760 ng/ml |
| Interstitial Fluid Level of Methadone 3 Hours After Daily Methadone Dose | Methadone Concentration in Plasma and Interstitial Fluid (ISF) Before and After Taking a Dose | Participant E | 5800 ng/ml |
| Interstitial Fluid Level of Methadone 3 Hours After Daily Methadone Dose | Methadone Concentration in Plasma and Interstitial Fluid (ISF) Before and After Taking a Dose | Participant F | 1300 ng/ml |
| Interstitial Fluid Level of Methadone 3 Hours After Daily Methadone Dose | Methadone Concentration in Plasma and Interstitial Fluid (ISF) Before and After Taking a Dose | Participant B | 17418 ng/ml |
| Interstitial Fluid Level of Methadone 3 Hours After Daily Methadone Dose | Methadone Concentration in Plasma and Interstitial Fluid (ISF) Before and After Taking a Dose | Participant D | 3300 ng/ml |
| Interstitial Fluid Level of Methadone 3 Hours After Daily Methadone Dose | Methadone Concentration in Plasma and Interstitial Fluid (ISF) Before and After Taking a Dose | Participant A | 2000 ng/ml |
| Interstitial Fluid Level of Methadone 3 Hours After Daily Methadone Dose | Methadone Concentration in Plasma and Interstitial Fluid (ISF) Before and After Taking a Dose | Participant C | 1200 ng/ml |
Primary
Methadone Metabolite/ 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine ( EDDP ) Concentration in ISF and Plasma Before and After Taking a Dose of Methadone
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.
Time frame: 1 day
Population: Patients that met the inclusion and exclusion criteria of the study. Only methadone taking cohort included in this measure, including patient taking gabapentin. Data collected prior to daily dose of Methadone and 3 hours after taking daily dose of methadone.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Plasma Level of Methadone Prior to Daily Dose of Methadone | Methadone Metabolite/ 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine ( EDDP ) Concentration in ISF and Plasma Before and After Taking a Dose of Methadone | Patient A | 135 ng/ml |
| Plasma Level of Methadone Prior to Daily Dose of Methadone | Methadone Metabolite/ 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine ( EDDP ) Concentration in ISF and Plasma Before and After Taking a Dose of Methadone | Patient B | 10 ng/ml |
| Plasma Level of Methadone Prior to Daily Dose of Methadone | Methadone Metabolite/ 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine ( EDDP ) Concentration in ISF and Plasma Before and After Taking a Dose of Methadone | Patient C | 21 ng/ml |
| Plasma Level of Methadone Prior to Daily Dose of Methadone | Methadone Metabolite/ 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine ( EDDP ) Concentration in ISF and Plasma Before and After Taking a Dose of Methadone | Patient D | 45 ng/ml |
| Plasma Level of Methadone Prior to Daily Dose of Methadone | Methadone Metabolite/ 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine ( EDDP ) Concentration in ISF and Plasma Before and After Taking a Dose of Methadone | Patient E | 54 ng/ml |
| Plasma Level of Methadone Prior to Daily Dose of Methadone | Methadone Metabolite/ 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine ( EDDP ) Concentration in ISF and Plasma Before and After Taking a Dose of Methadone | Patient F | 46 ng/ml |
| Plasma Level of Methadone 3 Hours After Taking Daily Dose | Methadone Metabolite/ 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine ( EDDP ) Concentration in ISF and Plasma Before and After Taking a Dose of Methadone | Patient F | 74 ng/ml |
| Plasma Level of Methadone 3 Hours After Taking Daily Dose | Methadone Metabolite/ 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine ( EDDP ) Concentration in ISF and Plasma Before and After Taking a Dose of Methadone | Patient D | 40.5 ng/ml |
| Plasma Level of Methadone 3 Hours After Taking Daily Dose | Methadone Metabolite/ 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine ( EDDP ) Concentration in ISF and Plasma Before and After Taking a Dose of Methadone | Patient A | 137 ng/ml |
| Plasma Level of Methadone 3 Hours After Taking Daily Dose | Methadone Metabolite/ 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine ( EDDP ) Concentration in ISF and Plasma Before and After Taking a Dose of Methadone | Patient C | 41 ng/ml |
| Plasma Level of Methadone 3 Hours After Taking Daily Dose | Methadone Metabolite/ 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine ( EDDP ) Concentration in ISF and Plasma Before and After Taking a Dose of Methadone | Patient B | 38 ng/ml |
| Plasma Level of Methadone 3 Hours After Taking Daily Dose | Methadone Metabolite/ 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine ( EDDP ) Concentration in ISF and Plasma Before and After Taking a Dose of Methadone | Patient E | 57 ng/ml |
| Interstitial Fluid Level of Methadone Pre Dose | Methadone Metabolite/ 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine ( EDDP ) Concentration in ISF and Plasma Before and After Taking a Dose of Methadone | Patient B | 290 ng/ml |
| Interstitial Fluid Level of Methadone Pre Dose | Methadone Metabolite/ 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine ( EDDP ) Concentration in ISF and Plasma Before and After Taking a Dose of Methadone | Patient C | 14 ng/ml |
| Interstitial Fluid Level of Methadone Pre Dose | Methadone Metabolite/ 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine ( EDDP ) Concentration in ISF and Plasma Before and After Taking a Dose of Methadone | Patient D | 0 ng/ml |
| Interstitial Fluid Level of Methadone Pre Dose | Methadone Metabolite/ 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine ( EDDP ) Concentration in ISF and Plasma Before and After Taking a Dose of Methadone | Patient F | 98 ng/ml |
| Interstitial Fluid Level of Methadone Pre Dose | Methadone Metabolite/ 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine ( EDDP ) Concentration in ISF and Plasma Before and After Taking a Dose of Methadone | Patient E | 0 ng/ml |
| Interstitial Fluid Level of Methadone Pre Dose | Methadone Metabolite/ 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine ( EDDP ) Concentration in ISF and Plasma Before and After Taking a Dose of Methadone | Patient A | 260 ng/ml |
| Interstitial Fluid Level of Methadone 3 Hours After Daily Methadone Dose | Methadone Metabolite/ 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine ( EDDP ) Concentration in ISF and Plasma Before and After Taking a Dose of Methadone | Patient E | 280 ng/ml |
| Interstitial Fluid Level of Methadone 3 Hours After Daily Methadone Dose | Methadone Metabolite/ 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine ( EDDP ) Concentration in ISF and Plasma Before and After Taking a Dose of Methadone | Patient F | 120 ng/ml |
| Interstitial Fluid Level of Methadone 3 Hours After Daily Methadone Dose | Methadone Metabolite/ 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine ( EDDP ) Concentration in ISF and Plasma Before and After Taking a Dose of Methadone | Patient B | 370 ng/ml |
| Interstitial Fluid Level of Methadone 3 Hours After Daily Methadone Dose | Methadone Metabolite/ 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine ( EDDP ) Concentration in ISF and Plasma Before and After Taking a Dose of Methadone | Patient D | 76 ng/ml |
| Interstitial Fluid Level of Methadone 3 Hours After Daily Methadone Dose | Methadone Metabolite/ 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine ( EDDP ) Concentration in ISF and Plasma Before and After Taking a Dose of Methadone | Patient A | 400 ng/ml |
| Interstitial Fluid Level of Methadone 3 Hours After Daily Methadone Dose | Methadone Metabolite/ 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine ( EDDP ) Concentration in ISF and Plasma Before and After Taking a Dose of Methadone | Patient C | 62 ng/ml |
Secondary
Buprenorphine Concentration in Plasma and ISF Before and After a Dose Taken
Plasma collected by venipuncture and ISF collected from the surface of the skin will be tested for buprenorphine using LC-MS analysis before and after a dose of buprenorphine has been taken
Time frame: 1 day
Population: Patients on 16mg or more of buprenorphine for Opioid Use Disorder. Only the buprenorphine taking cohort included in this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Plasma Level of Methadone Prior to Daily Dose of Methadone | Buprenorphine Concentration in Plasma and ISF Before and After a Dose Taken | Participant G | 2339 ng/ml |
| Plasma Level of Methadone Prior to Daily Dose of Methadone | Buprenorphine Concentration in Plasma and ISF Before and After a Dose Taken | Participant H | 0 ng/ml |
| Plasma Level of Methadone 3 Hours After Taking Daily Dose | Buprenorphine Concentration in Plasma and ISF Before and After a Dose Taken | Participant H | 15663 ng/ml |
| Plasma Level of Methadone 3 Hours After Taking Daily Dose | Buprenorphine Concentration in Plasma and ISF Before and After a Dose Taken | Participant G | 22459 ng/ml |
| Interstitial Fluid Level of Methadone Pre Dose | Buprenorphine Concentration in Plasma and ISF Before and After a Dose Taken | Participant G | 6509 ng/ml |
| Interstitial Fluid Level of Methadone Pre Dose | Buprenorphine Concentration in Plasma and ISF Before and After a Dose Taken | Participant H | 0 ng/ml |
| Interstitial Fluid Level of Methadone 3 Hours After Daily Methadone Dose | Buprenorphine Concentration in Plasma and ISF Before and After a Dose Taken | Participant G | 0 ng/ml |
| Interstitial Fluid Level of Methadone 3 Hours After Daily Methadone Dose | Buprenorphine Concentration in Plasma and ISF Before and After a Dose Taken | Participant H | 0 ng/ml |
Secondary
Pearson Correlation Coefficient for Methadone Metabolite / EDDP Levels in ISF and Blood
The Pearson correlation coefficient between the ISF and blood levels of EDDP were calculated using the Least Squared Method by Microsoft Excel software.
Time frame: 1 day
Population: Patients that met the criteria for inclusion and lacked exclusions as per protocol. We also excluded one patient that was taking 800mg of gabapentin qid due to the known effect of gabapentin on methadone clearance and drug-drug interactions. Only methadone taking cohort included in this data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Plasma Level of Methadone Prior to Daily Dose of Methadone | Pearson Correlation Coefficient for Methadone Metabolite / EDDP Levels in ISF and Blood | .84 Pearson Correlation Coefficient |
p-value: 0.0025t-test, 2 sided
Secondary
Pearson Correlation for Methadone Levels in ISF and Blood
The Pearson correlation coefficient of blood and ISF methadone levels was calculated using the Least Squared Method from Microsoft Excel software.
Time frame: 1 day
Population: Patients that met the criteria for inclusion and lacked exclusions as per protocol. We also excluded one patient that was taking 800mg of gabapentin qid due to the known effect of gabapentin on methadone clearance and drug-drug interactions. Only methadone taking cohort included in this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Plasma Level of Methadone Prior to Daily Dose of Methadone | Pearson Correlation for Methadone Levels in ISF and Blood | .805 Pearson Correlation Coefficient |
Comparison: patient plasma versus isf value for methadonep-value: 0.0049t-test, 2 sided