Assessment of Methadone Dose Taken

Recruiting now

Conditions studied: Methadone Toxicity, Methadone Overdose, Pain, Chronic, Drug Metabolism, Poor, CYP2D6-Related, Metabolism Medication Toxicity

In brief

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.

Key facts

Study ID

NCT05981573

Run by

Cari Health Inc.

People needed

30

Starts

2024-08-26

Expected to finish

2026-04-01

Last updated by the study team

2025-02-13

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Synergy — Lemon Grove, California, United States (enrolling)

Full record on ClinicalTrials.gov

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