Assessing Concentrations of Methadone and Its Metabolites

NCT06835582 | Enrolling By Invitation FDA Drug

• 1 other identifier: IRB004
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Opioid Use Disorder; Pain

Keywords

Pharmacokinetics; dose curve; electrochemistry; dose taken sensor; personalized dosing; pharmacogenomics

Outcome Measures

Primary Outcomes (4)

• 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

Interventions

Methadone DRUG

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.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cari Health Inc.: lead

Study Sites (1)

Synergy

Lemon Grove, California, 91945, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma

MeSH Terms

Conditions

Opioid-Related Disorders; Pain

Interventions

Methadone

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ketones; Organic Chemicals

Study Officials

• Charmaine Semenluk, MD, MD

  Synergy Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: February 19, 2025
• Study Start: March 17, 2025
• Primary Completion: December 1, 2025
• Study Completion: February 1, 2026
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)