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
| Condition(s) | Methadone Toxicity, Methadone Overdose, Pain, Chronic, Drug Metabolism, Poor, CYP2D6-Related, Metabolism Medication Toxicity |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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). 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. |
| Who can participate | Inclusion Criteria: * Age 18-70 * A prescription for methadone for chronic pain 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. Exclusion Criteria: * Age \<18 or \>70 * A condition preventing or complicating ISF collection * dermatological (skin) condition * immunodeficiency * recent blood donation * anemia * 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. |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Lead sponsor | Cari Health Inc. |
| Locations | Lemon Grove, California, United States |
| Start date | 2024-08-26 |
| NCT ID | NCT05981573 |
| Official listing | https://clinicaltrials.gov/study/NCT05981573 |