Status:

RECRUITING

Assessment of Methadone Dose Taken

Lead Sponsor:

Cari Health Inc.

Conditions:

Methadone Toxicity

Methadone Overdose

Eligibility:

All Genders

18-70 years

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, r...

Detailed Description

The investigator will conduct a non-randomized, non-blinded, feasibility study at a single center in the United States. The study will include up to 20 subjects of an equal number of male and female a...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

August 26 2024

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

April 1 2026

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT05981573

Start Date

August 26 2024

End Date

April 1 2026

Last Update

February 13 2025

Active Locations (1)

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1

Synergy

Lemon Grove, California, United States, 91945