NCT06835582

Assessing Concentrations of Methadone and Its Metabolites

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: Cari Health Inc. · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

An observational proof of concept method comparison study. Comparing Liquid Chromatography -Mass Spectroscopy to a new Quantitative Lateral Flow Immunoassay with an Optical Reader.

Detailed description

CARI Health, Inc.'s long-term goal is to address the problem of high dropout rates of patients receiving medication for opioid use disorder (MOUD; e.g., methadone) treatments, which has increased with the prevalence of fentanyl use, with an innovative point-of-care (PoC) device to enable science-based personalized dosing for patients receiving methadone treatment for opioid use disorder (OUD). The proposed solution consists of a customized analysis device that incorporates proprietary methadone detection technology for quickly measuring methadone and metabolite levels in the blood and calculating the methadone/metabolite ratio (MMR). To accomplish this long-term goal, the investigators aim to first quantitatively measure methadone doses taken and ethylidene-dimethyl-diphenyl pyrrolidine (EDDP) detection using lateral flow assays. At this stage, the investigators are not testing a device. They are first assessing whether methadone metabolism can be evaluated using lateral flow assays, which are simple paper-based diagnostic strips. The tests work similarly to a home pregnancy test, where a sample (like blood, urine, or saliva) flows along a test strip and interacts with antibodies or other molecules that capture the target substance. No clinical decisions will be made, no treatment will be applied, and no dosing will be changed based on the results learned in this study.

Conditions

• Opioid Use Disorder
• Pain

Interventions

Type	Name	Description
DRUG	Methadone	Comparing methadone point of care test to LC-MS to evalutate methadone and its metabolite levels pre dosing and after dosing using the patient's current methadone prescription.

Timeline

• Start date: 2025-03-17
• Primary completion: 2025-12-01
• Completion: 2026-02-01
• First posted: 2025-02-19
• Last updated: 2025-02-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study