N/A
Completed N=11
Assessment of Methadone and Buprenorphine in Interstitial Fluid
Source: ClinicalTrials.gov NCT05546229 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcomePrimary: Methadone Concentration in Plasma and Interstitial Fluid (ISF) Before and After Taking a Dose — 565; 640; 760; 2000 ng/ml
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Methadone Concentration in Plasma and Interstitial Fluid (ISF) Before and After Taking a Dose |
565; 640; 760; 2000; 240; 441 | — |
| 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 |
135; 137; 260; 400; 10; 38 | — |
| PRIMARY Methadone and Its Metabolite/ EDDP Concentrations Using Liquid Chromatography Mass Spectroscopy (LC-MS) in Subjects Not Taking Methadone |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Pearson Correlation for Methadone Levels in ISF and Blood |
.805 | .0049 sig |
| SECONDARY Pearson Correlation Coefficient for Methadone Metabolite / EDDP Levels in ISF and Blood |
.84 | .0025 sig |
| SECONDARY Buprenorphine Concentration in Plasma and ISF Before and After a Dose Taken |
2339; 22459; 6509; 0; 0; 15663 | — |
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.
Data sourced from ClinicalTrials.gov (NCT05546229). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.