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Search / Trial NCT05998876

Assessing Dose Taken in Opioid Use Disordered Patients With an Electrochemical Sensor

Launched by CARI HEALTH INC. · Aug 11, 2023

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Pharmacokinetics Differential Pulse Voltammetry Remote Medication Monitor Interstitial Fluid

ClinConnect Summary

This clinical trial, called CARI Health, is studying a new device designed to help people with opioid use disorder, specifically those taking methadone. The device is an electrochemical sensor that checks the levels of methadone in the body and provides real-time information to doctors, counselors, patients, and their families. This means everyone can see if the prescribed dose has been taken, which can help methadone clinics offer more flexibility with take-home doses and potentially keep more patients in treatment.

To participate in the trial, you need to be between 18 and 70 years old and have a prescription for liquid methadone of at least 10 mg. You should also have taken your methadone as prescribed for the last two days and have been given at least three take-home doses before. However, some people may not be eligible, such as those with certain medical conditions, severe mental health issues, or those who are pregnant. If you join, you can expect to wear the sensor and provide information about your methadone usage, helping improve treatment options for others in the future. The trial is not yet recruiting participants, so you will need to wait for more information if you are interested.

Gender

ALL

Eligibility criteria

  • Inclusion criteria for methadone group includes:
  • Age 18-70. A prescription for liquid methadone at a dose of 10mg or more. Taken methadone as prescribed in the last 2 days. Has been prescribed at least 3 take homes
  • Exclusion criteria for methadone group includes:
  • Age \<18 or \>70. A condition preventing or complicating ISF collection. Conditions may include dermatological (skin) condition, immunodeficiency, bleeding diathesis, recent blood donation, anemia, cancer, congestive heart failure, or tuberculosis. Any active severe depression (e.g., suicidal ideation) or mania symptoms.
  • 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.

About Cari Health Inc.

Cari Health Inc. is a pioneering clinical trial sponsor dedicated to advancing innovative healthcare solutions through rigorous research and development. With a focus on enhancing patient outcomes, Cari Health Inc. leverages cutting-edge technology and comprehensive methodologies to conduct clinical trials across various therapeutic areas. Committed to ethical practices and regulatory compliance, the organization collaborates with healthcare professionals, researchers, and institutions to ensure the highest standards of quality and safety in its studies. Through its efforts, Cari Health Inc. aims to contribute significantly to the medical community and improve the lives of patients worldwide.

Locations

Patients applied

0 patients applied

Trial Officials

Mohammad Bari, MD

Principal Investigator

Synergy Research Inc.

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported