Methadone ToxicityNCT06837571
Methadone Dose Monitoring With a Remote Medication Monitor
An observational study of Methadone Toxicity and Methadone Overdose, run by Cari Health Inc. at 1 site in United States.
Trial summary
Proof of concept: Pilot Study A Pilot, proof of concept, observational study with a long-term goal to develop a minimally invasive wearable Remote Medication Monitor (RMM) that provides continuous, real-time data on methadone levels in interstitial fluid (ISF). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Methadone Toxicity, Methadone Overdose, Pain, Chronic
- What is being tested?
- Measurement of Methadone in the Interstitial Fluid (ISF) before and after prescribed dose taken ex vivo, Measurement of Methadone in the Interstitial Fluid before and after prescribed dose taken in vivo and ISF Extraction Device 2
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Apr 2025to Jun 2025
- 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 taking at least 10mg of methadone per day for chronic pain or opioid use disorder,
Who may be able to join
- Age 18-70
- A prescription for methadone at a dose of 10mg or more for at least one week.
- Taking methadone as prescribed during the last 4 days before consent to participate in the study.
Who cannot join
- Age <18 or >70
- A condition preventing or complicating ISF collection
- dermatological (skin) condition
- immunodeficiency
- recent blood donation
- anemia
Show all 19Show fewer
- end stage renal disease
- liver cirrhosis
- cancer
- congestive heart failure
- bleeding diathesis
- tuberculosis (TB)
- Any active severe depression
- suicidal ideation
- mania symptoms
- Pregnancy
- Intending to become pregnant during the course of the study
- Enrolled in a substance use disorder treatment program
- 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.
United States1 site
Synergy
Lemon Grove, California, 91945
Woody Woodman
Ryan Woodman
About this study
Official title: Assessment of Methadone Dose Taken
Proof of concept: Pilot Study
A Pilot, proof of concept, observational study with a long-term goal to develop a minimally invasive wearable Remote Medication Monitor (RMM) that provides continuous, real-time data on methadone levels in interstitial fluid (ISF). An RMM could be used as a medication adherence monitor and would allow for the physician, counselor, patient, or family member to remotely verify that a physician-prescribed dose has been taken.
Read the detailed description
The investigator will conduct a non-randomized, non-blinded, feasibility study at a single center in the United States. The study will include up to 20 subjects of an equal number of male and female adults (ages 18-70) who have a prescription for methadone.
In Aim 1, the investigators will determine if an RMM can continuously assess the status of taking a prescribed dose of methadone over time, by inserting the dermal ISF sensing elements into the subjects' abdominal skin. Biosample collections (i.e., ISF, blood) and pharmacokinetic monitoring will occur over a 6-hour period. By completing this aim, the investigator will determine if a physician is able to recognize the pharmacokinetic profile of a taken dose of methadone. The physician will see a dosing curve display generated from dermal ISF dialysis fluid sampling using an external fiberoptic sensor system that is worn continuously on the abdomen similar to continuous glucose monitors.
- Conditions
- Methadone Toxicity, Methadone Overdose, Pain, Chronic, Drug Metabolism, Poor, CYP2D6-Related, Metabolism Medication Toxicity
- Being tested
- Measurement of Methadone in the Interstitial Fluid (ISF) before and after prescribed dose taken ex vivo, Measurement of Methadone in the Interstitial Fluid before and after prescribed dose taken in vivo, ISF Extraction Device 2
- Keywords
- Pharmacokinetics
- Medical subject headings
- Chronic Pain, Drug Metabolism, Poor, CYP2D6-Related
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of Methadone in the Interstitial Fluid (ISF) before and after prescribed dose taken ex vivoDiagnostic test
Also called dose taken peak-trough test
Measurement of Methadone and its metabolites in interstitial fluid with Liquid Chromatography - Mass Spectroscopy (LC-MS) and Aptamer based Assay
Measurement of Methadone in the Interstitial Fluid before and after prescribed dose taken in vivoDrug
Also called In vivo Continuous molecular monitoring
Measurement of Methadone and its metabolites in ISF with LC-MS and RMM
ISF Extraction Device 2Device
Also called Ascilion
Up to 15 minute periods of continuous ISF collection for analysis
| Study group | Role | What they receive |
|---|---|---|
| Visit 1 | AIM 2 : Determine if an RMM can assess the status of taking a prescribed dose of methadone. To complete this aim, the peak and trough concentrations of a witnessed methadone dose will be assessed in dermal ISF collected through the surface of the skin using existing ISF extraction methods and assessed outside the body via with and dermal ISF dialysis tube and external aptamer switch based fiberoptic sensor continuously for 6 hours. Methadone and protein binding factors are independently assessed in the collected ISF samples using (LC-MS and Lateral Flow Assays). We hypothesize that the methadone peak and trough levels in the blood samples will correlate with the levels of methadone in ISF.
The Investigators hypothesize that the methadone peak and trough levels in the blood samples will correlate with the levels of methadone in ISF. Receives: Device: ISF Extraction Device 2 | |
| Visit 2 | AIM 3: Determine if an RMM can continuously assess the status of taking a prescribed dose of methadone over time. To complete this aim, the pharmacokinetic profile of a witnessed methadone dose will be assessed in ISF dialysate continuously from the surface of the skin using the RMM for up to 12 hours (Aim 3a) and over 3 days (Aim 3b). Methadone will also be assessed over these three time points in the continuously collected ISF samples using LC-MS and Lateral Flow Assays. The Investigators hypothesize that a clinician can recognize a dose taken from the RMM generated measurements of dialyzed ISF. Receives: Diagnostic Test: Measurement of Methadone in the Interstitial Fluid (ISF) before and after prescribed dose taken ex vivo; Drug: Measurement of Methadone in the Interstitial Fluid before and after prescribed dose taken in vivo; Device: ISF Extraction Device 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Methadone Concentration in ISF before and after a dose
measure dermal interstitial fluid with LC-MS for methadone before and after a daily dose
Measured: 1 day
Methadone Concentration in blood before and after a dose
measure blood for methadone with LC-MS before and after a daily dose
Measured: 1 day
Concentration of Methadone in ISF with LC-MS versus Fluorescent Aptamer Switch
measure ISF with two procedures (Liquid Chromatography - Mass Spectroscopy and Fluoroscopy
Measured: 2 days
Concentration of Methadone in blood with LC-MS versus Fluorescent Aptamer Switch
measure blood with two procedures (Liquid Chromatography - Mass Spectroscopy and Fluoroscopy
Measured: 2 days
Pearson Correlation of Methadone between ISF and Blood
measure blood and ISF methadone with LC-MS and determine pearson correlation
Measured: 2 days
Pearson Correlation between Fluoroscopy and LC-MS ISF Methadone
measure ISF for methadone by LC-MS and Fluoroscopy and determine Pearson correlation
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start26 Apr 2025 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Methadone ToxicityStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cari Health Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charmaine Semenluk, MD, Principal investigator, Synergy Research Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06837571
- Sponsor's protocol ID
- IRB3RMM
- Status last verified
- Feb 2025
- First submitted
- 15 Feb 2025
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Friedel M, Werbovetz B, Drexelius A, Watkins Z, Bali A, Plaxco KW, Heikenfeld J. Continuous molecular monitoring of human dermal interstitial fluid with microneedle-enabled electrochemical aptamer sensors. Lab Chip. 2023 Jul 12;23(14):3289-3299. doi: 10.1039/d3lc00210a.
PubMed 37395135Gomes NO, Raymundo-Pereira PA. On-Site Therapeutic Drug Monitoring of Paracetamol Analgesic in Non-Invasively Collected Saliva for Personalized Medicine. Small. 2023 Mar;19(12):e2206753. doi: 10.1002/smll.202206753. Epub 2023 Jan 15.
PubMed 36642790Ribet F, Bendes A, Fredolini C, Dobielewski M, Bottcher M, Beck O, Schwenk JM, Stemme G, Roxhed N. Microneedle Patch for Painless Intradermal Collection of Interstitial Fluid Enabling Multianalyte Measurement of Small Molecules, SARS-CoV-2 Antibodies, and Protein Profiling. Adv Healthc Mater. 2023 May;12(13):e2202564. doi: 10.1002/adhm.202202564. Epub 2023 Feb 21.
PubMed 36748807
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Methadone Dose Taken
- ClinicalTrials.gov ID
- NCT06837571
- Acronym / sponsor ID
- IRB3RMM
- Conditions
- Methadone Toxicity, Methadone Overdose, Pain, Chronic, Drug Metabolism, Poor, CYP2D6-Related, Metabolism Medication Toxicity
- Keywords
- Pharmacokinetics
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cari Health Inc.University, hospital or other
- Study start
- 26 Apr 2025 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 20 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.
Proof of concept: Pilot Study
A Pilot, proof of concept, observational study with a long-term goal to develop a minimally invasive wearable Remote Medication Monitor (RMM) that provides continuous, real-time data on methadone levels in interstitial fluid (ISF). An RMM could be used as a medication adherence monitor and would allow for the physician, counselor, patient, or family member to remotely verify that a physician-prescribed dose has been taken.
Detailed description
The investigator will conduct a non-randomized, non-blinded, feasibility study at a single center in the United States. The study will include up to 20 subjects of an equal number of male and female adults (ages 18-70) who have a prescription for methadone.
In Aim 1, the investigators will determine if an RMM can continuously assess the status of taking a prescribed dose of methadone over time, by inserting the dermal ISF sensing elements into the subjects' abdominal skin. Biosample collections (i.e., ISF, blood) and pharmacokinetic monitoring will occur over a 6-hour period. By completing this aim, the investigator will determine if a physician is able to recognize the pharmacokinetic profile of a taken dose of methadone. The physician will see a dosing curve display generated from dermal ISF dialysis fluid sampling using an external fiberoptic sensor system that is worn continuously on the abdomen similar to continuous glucose monitors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Visit 1 | – | Device: ISF Extraction Device 2AIM 2 : Determine if an RMM can assess the status of taking a prescribed dose of methadone. To complete this aim, the peak and trough concentrations of a witnessed methadone dose will be assessed in dermal ISF collected through the surface of the skin using existing ISF extraction methods and assessed outside the body via with and dermal ISF dialysis tube and external aptamer switch based fiberoptic sensor continuously for 6 hours. Methadone and protein binding factors are independently assessed in the collected ISF samples using (LC-MS and Lateral Flow Assays). We hypothesize that the methadone peak and trough levels in the blood samples will correlate with the levels of methadone in ISF. The Investigators hypothesize that the methadone peak and trough levels in the blood samples will correlate with the levels of methadone in ISF. |
| Visit 2 | – | Diagnostic Test: Measurement of Methadone in the Interstitial Fluid (ISF) before and after prescribed dose taken ex vivo, Drug: Measurement of Methadone in the Interstitial Fluid before and after prescribed dose taken in vivo, Device: ISF Extraction Device 2AIM 3: Determine if an RMM can continuously assess the status of taking a prescribed dose of methadone over time. To complete this aim, the pharmacokinetic profile of a witnessed methadone dose will be assessed in ISF dialysate continuously from the surface of the skin using the RMM for up to 12 hours (Aim 3a) and over 3 days (Aim 3b). Methadone will also be assessed over these three time points in the continuously collected ISF samples using LC-MS and Lateral Flow Assays. The Investigators hypothesize that a clinician can recognize a dose taken from the RMM generated measurements of dialyzed ISF. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients taking at least 10mg of methadone per day for chronic pain or opioid use disorder,
Key inclusion criteria (3 listed)
- Age 18-70
- A prescription for methadone at a dose of 10mg or more for at least one week.
- Taking methadone as prescribed during the last 4 days before consent to participate in the study.
Key exclusion criteria (19 listed)
- Age <18 or >70
- A condition preventing or complicating ISF collection
- dermatological (skin) condition
- immunodeficiency
- recent blood donation
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 |
|---|---|---|
| Measurement of Methadone in the Interstitial Fluid (ISF) before and after prescribed dose taken ex vivoAlso: dose taken peak-trough testMeasurement of Methadone and its metabolites in interstitial fluid with Liquid Chromatography - Mass Spectroscopy (LC-MS) and Aptamer based Assay | Diagnostic test | Visit 2 |
| Measurement of Methadone in the Interstitial Fluid before and after prescribed dose taken in vivoAlso: In vivo Continuous molecular monitoringMeasurement of Methadone and its metabolites in ISF with LC-MS and RMM | Drug | Visit 2 |
| ISF Extraction Device 2Also: AscilionUp to 15 minute periods of continuous ISF collection for analysis | Device | Visit 1, Visit 2 |
Primary outcome
Methadone Concentration in ISF before and after a dose
Time frame: 1 day
measure dermal interstitial fluid with LC-MS for methadone before and after a daily dose
Methadone Concentration in blood before and after a dose
Time frame: 1 day
measure blood for methadone with LC-MS before and after a daily dose
Concentration of Methadone in ISF with LC-MS versus Fluorescent Aptamer Switch
Time frame: 2 days
measure ISF with two procedures (Liquid Chromatography - Mass Spectroscopy and Fluoroscopy
Concentration of Methadone in blood with LC-MS versus Fluorescent Aptamer Switch
Time frame: 2 days
measure blood with two procedures (Liquid Chromatography - Mass Spectroscopy and Fluoroscopy
Pearson Correlation of Methadone between ISF and Blood
Time frame: 2 days
measure blood and ISF methadone with LC-MS and determine pearson correlation
Pearson Correlation between Fluoroscopy and LC-MS ISF Methadone
Time frame: 2 days
measure ISF for methadone by LC-MS and Fluoroscopy and determine Pearson correlation
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 20 Feb 2025.
- Background: PubMed 37395135Friedel M, Werbovetz B, Drexelius A, Watkins Z, Bali A, Plaxco KW, Heikenfeld J. Continuous molecular monitoring of human dermal interstitial fluid with microneedle-enabled electrochemical aptamer sensors. Lab Chip. 2023 Jul 12;23(14):3289-3299. doi: 10.1039/d3lc00210a.
- Background: PubMed 36642790Gomes NO, Raymundo-Pereira PA. On-Site Therapeutic Drug Monitoring of Paracetamol Analgesic in Non-Invasively Collected Saliva for Personalized Medicine. Small. 2023 Mar;19(12):e2206753. doi: 10.1002/smll.202206753. Epub 2023 Jan 15.
- Background: PubMed 36748807Ribet F, Bendes A, Fredolini C, Dobielewski M, Bottcher M, Beck O, Schwenk JM, Stemme G, Roxhed N. Microneedle Patch for Painless Intradermal Collection of Interstitial Fluid Enabling Multianalyte Measurement of Small Molecules, SARS-CoV-2 Antibodies, and Protein Profiling. Adv Healthc Mater. 2023 May;12(13):e2202564. doi: 10.1002/adhm.202202564. Epub 2023 Feb 21.
- Cari Health WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Methadone Toxicity
RecruitingObservational study
Assessment of Methadone Dose Taken
Methadone Toxicity, Methadone Overdose
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 principal investigator
Synergy Research Inc.
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 Methadone Toxicity and Methadone Overdose, 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 3 inclusion and 19 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: opening soon, as of the sponsor's last update on 20 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?
Contact Foster P Carr, MD (6192343725, drcarr@carihealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Methadone Concentration in ISF before and after a dose (time frame: 1 day). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06837571, which also lists 3 linked publications.
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 20 Feb 2025.