Assessing Concentrations of Methadone and Its Metabolites

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Pain; Opioid Use Disorder
• Intervention / Treatment: Drug: Methadone

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.

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

Study Locations

• United States
  • California
    • Lemon Grove, California, United States, 91945
      • Synergy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with pain or opioid use disorder that are taking methadone daily.

Description

Inclusion Criteria:

Age 18-70. A prescription for methadone at a dose of 10mg or more for at least 7 days. Participants may be taking the methadone to treat an OUD or for pain. Taking methadone as prescribed during the last 4 days before consent to participate in the study.

Has been prescribed at least 1 day of take-home doses.

Exclusion criteria for methadone group includes:

Age <18 or >70. A condition preventing or complicating blood collection. Conditions may include dermatological (skin) condition, bleeding diathesis, immunodeficiency, recent blood donation, anemia, end stage renal disease, liver cirrhosis, cancer, congestive heart failure, bleeding diathesis, tuberculosis (TB), active severe depression (e.g., suicidal ideation), or mania symptoms.

Tattoo or piercing close to sampling area. Under a conservatorship.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of whole blood methadone levels with Lateral Flow Assay	whole blood measurement of methadone	1 day
Measurement of whole blood methadone metabolite Levels with Lateral Flow Assay	Whole blood measurement of methadone metabolite	1 day
Measurement of plasma methadone with LC-MS	plasma methadone with LC-MS	1 day
Measurement of plasma methadone metabolite with LC-MS	plasma methadone metabolite with LC-MS	1 day

Collaborators and Investigators

• Sponsor: Cari Health Inc.
• Investigators: Principal Investigator: Charmaine Semenluk, MD, MD, Synergy Research

Study record dates

Study Major Dates

• Study Start (Estimated): March 17, 2025
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: February 11, 2025
• First Submitted That Met QC Criteria: February 14, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 14, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Pharmacokinetics; pharmacogenomics; dose curve; electrochemistry; dose taken sensor; personalized dosing
• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Opioid-Related Disorders; Physiological Effects of Drugs; Peripheral Nervous System Agents; Central Nervous System Depressants; Sensory System Agents; Analgesics; Analgesics, Opioid; Narcotics; Respiratory System Agents; Antitussive Agents; Methadone
• Other Study ID Numbers: IRB004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No