Monitoring methadone levels using a wearable device

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational pilot study aims to develop a minimally invasive wearable Remote Medication Monitor (RMM) that continuously tracks methadone levels in interstitial fluid. The study will involve up to 20 adult participants who have been prescribed methadone for chronic pain. It will assess the ability of the RMM to provide real-time data on medication adherence and pharmacokinetic profiles through biosample collections over a 6-hour period. The study will be conducted at a single center in the United States and will include two separate visits for data collection.

Why it matters

Who can join: the full rules

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.

Where it's running

• Synergy
  Lemon Grove, California, United States Recruiting

Study contacts

• Principal investigator: Charmaine Semenluk, MD — Synergy Research Inc.
• Study coordinator: Foster P Carr, MD
• Email: drcarr@carihealth.com
• Phone: 6192343725

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.