| NCT ID | NCT05981573 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Cari Health Inc. |
| Condition | Methadone Toxicity |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-08-26 |
| Primary Completion | 2026-03 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2024-08-26 with a primary completion date of 2026-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Charmaine Semenluk, MD
PRINCIPAL INVESTIGATOR
Synergy Research Inc.
Frequently Asked Questions
Who can join the NCT05981573 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Methadone Toxicity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05981573 currently recruiting?
Yes, NCT05981573 is actively recruiting participants. Contact the research team at drcarr@carihealth.com for enrollment information.
Where is the NCT05981573 trial being conducted?
This trial is being conducted at Lemon Grove, United States.
Who is sponsoring the NCT05981573 clinical trial?
NCT05981573 is sponsored by Cari Health Inc.. The principal investigator is Charmaine Semenluk, MD at Synergy Research Inc.. The trial plans to enroll 30 participants.