Home › Chronic Pain › NCT05981573
Assessment of Methadone Dose Taken
Who can join
Ages 18 to 70 · All sexes
Full eligibility criteria
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.
About the study
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.
What is being tested
- Measurement of Methadone in the Interstitial Fluid (ISF) before and after prescribed dose taken ex vivo (diagnostic test)
- Measurement of Methadone in the Interstitial Fluid before and after prescribed dose taken in vivo (drug)
- ISF Extraction Device 2 (device)
Sponsor: Cari Health Inc. · Participants: 30 · Started: Aug 26, 2024
Contact the study team
- Foster P Carr, MD · Phone: 6192343725
Official record on ClinicalTrials.gov — NCT05981573
Locations in the U.S.
| California | Synergy, Lemon Grove |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.