Monitoring methadone levels using a wearable device
Assessment of Methadone Dose Taken
This study is testing a new wearable device that tracks methadone levels in people with chronic pain to see how well it helps monitor their medication use.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Cari Health Inc. Academic / other |
| Locations | 1 site (Lemon Grove, California) |
| Trial ID | NCT05981573 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 who have a prescription for methadone for chronic pain at a dose of 10mg or more.
Not a fit: Patients with conditions that complicate ISF collection or those enrolled in substance use disorder treatment programs may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance medication adherence monitoring for patients on methadone, potentially reducing the risk of toxicity and overdose.
How similar studies have performed: While this approach is innovative, similar studies have not been widely reported, indicating that this may be a novel exploration in medication monitoring.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Lemon Grove, California
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.