[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100514674":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":46,"centralContacts":51,"locations":60,"responsibleParty":81,"collaborators":10,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":87,"acronym":10,"eligibilityCriteria":88,"healthyVolunteers":85,"sex":89,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":10,"studyType":95,"phases":10,"briefSummary":96,"conditions":97,"keywords":103,"overallStatus":63,"whyStopped":10,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Cari Health Inc.","OTHER",[8,16,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Visit 2",null,"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 ISF collected through the surface of the skin using existing ISF extraction methods and assessed outside the body via Lateral Flow Immunoassay for up to 6 hours. Methadone metabolites and protein binding factors may be assessed in the collected ISF samples using (LC-MS). We hypothesize that the methadone peak and trough levels as well as the metabolites in the blood samples will correlate with the levels of methadone in ISF.\n\nThe Investigators hypothesize that the methadone peak and trough levels as well as the metabolites in the blood samples will correlate with the levels of methadone in ISF.",[13,14,15],"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",{"label":17,"type":10,"description":18,"interventionNames":19},"Visit 3","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 continuously from the surface of the skin using the RMM for up to 12 hours (Aim 3a) and over 3 days (Aim 3b). Methadone metabolites will also be assessed over these three time points in the continuously collected ISF samples using LC-MS. The Investigators hypothesize that a clinician can recognize a dose taken and the methadone metabolites from the RMM generated measurements in the ISF.",[13,14,15],{"label":21,"type":10,"description":22,"interventionNames":23},"Visit 1","Aim 1: Characterize dermal interstitial fluid (ISF) in healthy adults with Liquid Chromatography-Mass Spectroscopy (LC-MS) based proteomics. To complete this aim, the dermal interstitial fluid will be extracted from the surface of the skin of healthy adults over a period up to 3 hours. The participants may also have continuous monitoring of their interstitial fluid using the RMM. We hypothesize that the protein content of ISF will be 50% the level of normal human serum levels and contain potential protein biomarkers of disease status.",[15],[25,32,39],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DIAGNOSTIC_TEST","Measurement of Methadone in the Interstitial Fluid (ISF) before and after prescribed dose taken ex vivo","Measurement of Methadone and its metabolites in interstitial fluid with Liquid Chromatography - Mass Spectroscopy (LC-MS) and Aptamer based Assay",[9,17],[31],"dose taken peak-trough test",{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"DRUG","Measurement of Methadone in the Interstitial Fluid before and after prescribed dose taken in vivo","Measurement of Methadone and its metabolites in ISF with LC-MS and RMM",[9,17],[38],"In vivo Continuous molecular monitoring",{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"DEVICE","ISF Extraction Device 2","Up to 15 minute periods of continuous ISF collection for analysis",[21,9,17],[45],"Ascilion",[47],{"name":48,"affiliation":49,"role":50},"Charmaine Semenluk, MD","Synergy Research Inc.","PRINCIPAL_INVESTIGATOR",[52,57],{"name":53,"role":54,"phone":55,"phoneExt":10,"email":56},"Foster P Carr, MD","CONTACT","6192343725","drcarr@carihealth.com",{"name":58,"role":54,"phone":10,"phoneExt":10,"email":59},"Torsten Feibig, PhD","torsten@carihealth.com",[61],{"facility":62,"status":63,"city":64,"state":65,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"Synergy","RECRUITING","Lemon Grove","California","91945","United States","US",{"type":70,"coordinates":71},"Point",[72,73],-117.03142,32.74255,{"lat":73,"lon":72},[76,78,80],{"name":77,"role":54,"phone":10,"phoneExt":10,"email":10},"Woody Woodman",{"name":79,"role":54,"phone":10,"phoneExt":10,"email":10},"Ryan Woodman",{"name":48,"role":50,"phone":10,"phoneExt":10,"email":10},{"type":82,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100514674","assessment-of-methadone-dose-taken-100514674",false,"NCT05981573","Assessment of Methadone Dose Taken","Inclusion Criteria:\n\n* Age 18-70\n* A prescription for methadone for chronic pain at a dose of 10mg or more for at least one week.\n* Taking methadone as prescribed during the last 4 days before consent to participate in the study.\n\nExclusion Criteria:\n\n* Age \\\u003C18 or \\>70\n* A condition preventing or complicating ISF collection\n* dermatological (skin) condition\n* immunodeficiency\n* recent blood donation\n* anemia\n* end stage renal disease\n* liver cirrhosis\n* cancer\n* congestive heart failure\n* bleeding diathesis\n* tuberculosis (TB)\n* Any active severe depression\n* suicidal ideation\n* mania symptoms\n* Pregnancy\n* Intending to become pregnant during the course of the study\n* Enrolled in a substance use disorder treatment program\n* Under a conservatorship.","ALL","18 Years","70 Years",{"count":93,"type":94},30,"ESTIMATED","OBSERVATIONAL","Proof of concept: Pilot Study\n\nA 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.",[98,99,100,101,102],"Methadone Toxicity","Methadone Overdose","Pain, Chronic","Drug Metabolism, Poor, CYP2D6-Related","Metabolism Medication Toxicity",[104],"Pharmacokinetics","2025-02-11",{"date":107,"type":108},"2025-02-13","ACTUAL",{"date":110,"type":108},"2024-08-26",{"date":112,"type":94},"2026-04",{"name":5,"class":6},1]