Clinical trial NCT06835582: Assessing Concentrations of Methadone and Its Metabolites
Official title: Assessing Concentrations of Methadone and Its Metabolites
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Opioid Use Disorder
Pain
Keywords: Pharmacokinetics
dose curve
electrochemistry
dose taken sensor
personalized dosing
pharmacogenomics
Lead sponsor: Cari Health Inc.
Sponsor class: OTHER
First posted: 2025-02-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with pain or opioid use disorder that are taking methadone daily.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Measurement of whole blood methadone levels with Lateral Flow Assay
timeFrame: 1 day
measure: Measurement of whole blood methadone metabolite Levels with Lateral Flow Assay
timeFrame: 1 day
measure: Measurement of plasma methadone with LC-MS
timeFrame: 1 day
measure: Measurement of plasma methadone metabolite with LC-MS
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Lemon Grove
country: United States
facility: Synergy
state: California
Study officials:
affiliation: Synergy Research
name: Charmaine Semenluk, MD, MD
role: PRINCIPAL_INVESTIGATOR
References: