Opioid Use DisorderNCT06835582
Assessing Concentrations of Methadone and Its Metabolites
An observational study of Opioid Use Disorder and Pain, run by Cari Health Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Opioid Use Disorder, Pain
- What is being tested?
- Methadone
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Mar 2025to Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with pain or opioid use disorder that are taking methadone daily.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
An observational proof of concept method comparison study. Comparing Liquid Chromatography -Mass Spectroscopy to a new Quantitative Lateral Flow Immunoassay with an Optical Reader.
Read the 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
- Being tested
- Methadone
- Keywords
- Pharmacokinetics, dose curve, electrochemistry, dose taken sensor, personalized dosing, pharmacogenomics
- Medical subject headings
- Opioid-Related Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethadoneDrug
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of whole blood methadone levels with Lateral Flow Assay
whole blood measurement of methadone
Measured: 1 day
Measurement of whole blood methadone metabolite Levels with Lateral Flow Assay
Whole blood measurement of methadone metabolite
Measured: 1 day
Measurement of plasma methadone with LC-MS
plasma methadone with LC-MS
Measured: 1 day
Measurement of plasma methadone metabolite with LC-MS
plasma methadone metabolite with LC-MS
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start17 Mar 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cari Health Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charmaine Semenluk, MD, MD, Principal investigator, Synergy Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06835582
- Sponsor's protocol ID
- IRB004
- Status last verified
- Feb 2025
- First submitted
- 11 Feb 2025
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Concentrations of Methadone and Its Metabolites
- ClinicalTrials.gov ID
- NCT06835582
- Acronym / sponsor ID
- IRB004
- Conditions
- Opioid Use Disorder, Pain
- Keywords
- Pharmacokinetics, dose curve, electrochemistry, dose taken sensor, personalized dosing, pharmacogenomics
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cari Health Inc.University, hospital or other
- Study start
- 17 Mar 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 19 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with pain or opioid use disorder that are taking methadone daily.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethadoneComparing 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. | Drug | – |
Primary outcome
Measurement of whole blood methadone levels with Lateral Flow Assay
Time frame: 1 day
whole blood measurement of methadone
Measurement of whole blood methadone metabolite Levels with Lateral Flow Assay
Time frame: 1 day
Whole blood measurement of methadone metabolite
Measurement of plasma methadone with LC-MS
Time frame: 1 day
plasma methadone with LC-MS
Measurement of plasma methadone metabolite with LC-MS
Time frame: 1 day
plasma methadone metabolite with LC-MS
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Charmaine Semenluk, MD, MD principal investigator
Synergy Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid Use Disorder and Pain, run by Cari Health Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of whole blood methadone levels with Lateral Flow Assay (time frame: 1 day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.