Assessing Dose Taken in Opioid Use Disordered Patients With an Electrochemical Sensor
NCT ID: NCT05998876
Last Updated: 2023-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
45 participants
OBSERVATIONAL
2024-02-29
2024-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Assessment of Methadone Dose Taken
NCT05981573
Methadone Dose Monitoring With a Remote Medication Monitor
NCT06837571
Assessing Concentrations of Methadone and Its Metabolites
NCT06835582
Methadone Monitoring for Insights Into Adverse Events
NCT01191242
Evaluating a Novel Medication Device for Methadone Dosing
NCT03254043
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Phase 1 detection over 3-6 hours (N=10)
Aim 1: Detect methadone and one or more of its metabolites in interstitial fluid (ISF) with differential pulse voltammetry (DPV) Aim 2: Correlate in vitro blood-based LC-MS and DPV Scans with Intradermal Microneedle based DPV Scans Aim 3: Accurately identify that a dose of methadone has been taken Aim 4: Determine the frequency and severity of any adverse events up to 6 hours.
Phase 2 detection over 12 hours (N=15)
Aim 5. Quantitate methadone and one or more of its metabolites in ISF with DPV over 12 hrs.
Aim 6: Determine the frequency and severity of any adverse events up to 12 hours
Phase 3 detection over 3 days N=20 ( 15 single dosed subjects, 5 split dosed subjects )
Aim 7. Quantitate methadone and one or more of its metabolites in ISF with DPV over 3 days.
Aim 8. Accurately identify a dose or half a dose has been taken Aim 9: Determine the frequency and severity of any adverse events up to 3 days
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
3-6 HRS
Microneedle electrode array placed into dermis for up to 6 hours. DPV Scans performed at a frequency of 1-20 per hour.
Remote Medication Monitor (RMM) - Prototype
Inserted Microneedle Electrode Array for assaying dermal interstitial fluid.
Daily Methadone Dose
patient takes their prescribed daily dose of methadone
12 HRS
Microneedle electrode array placed into dermis for up to 12 hrs. DPV Scans performed at a frequency of 1-20 per hour.
Remote Medication Monitor (RMM) - Prototype
Inserted Microneedle Electrode Array for assaying dermal interstitial fluid.
Daily Methadone Dose
patient takes their prescribed daily dose of methadone
3 Days
Microneedle electrode array placed into dermis for up to 3 days. DPV Scans performed at a frequency of 1-20 per hour.
Remote Medication Monitor (RMM) - Prototype
Inserted Microneedle Electrode Array for assaying dermal interstitial fluid.
Daily Methadone Dose
patient takes their prescribed daily dose of methadone
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Remote Medication Monitor (RMM) - Prototype
Inserted Microneedle Electrode Array for assaying dermal interstitial fluid.
Daily Methadone Dose
patient takes their prescribed daily dose of methadone
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
Pregnancy, or intending to become pregnant during the course of the study. Patients determined to be unstable for enrollment or take homes by the Outpatient Treatment Program (OTP).
Under a conservatorship.
18 Years
70 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cari Health Inc.
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Mohammad Bari, MD
Role: PRINCIPAL_INVESTIGATOR
Synergy Research Inc.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Related Links
Access external resources that provide additional context or updates about the study.
Cari Health Website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IRB005
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.