RECRUITING

Assessment of Methadone Dose Taken

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Assessment of Methadone Dose Taken

Quick Facts

Study Start:2024-08-26
Study Completion:2026-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05981573

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18-70
  2. * A prescription for methadone for chronic pain at a dose of 10mg or more for at least one week.
  3. * Taking methadone as prescribed during the last 4 days before consent to participate in the study.
  1. * Age \<18 or \>70
  2. * A condition preventing or complicating ISF collection
  3. * dermatological (skin) condition
  4. * immunodeficiency
  5. * recent blood donation
  6. * anemia
  7. * end stage renal disease
  8. * liver cirrhosis
  9. * cancer
  10. * congestive heart failure
  11. * bleeding diathesis
  12. * tuberculosis (TB)
  13. * Any active severe depression
  14. * suicidal ideation
  15. * mania symptoms
  16. * Pregnancy
  17. * Intending to become pregnant during the course of the study
  18. * Enrolled in a substance use disorder treatment program
  19. * Under a conservatorship.

Contacts and Locations

Study Contact

Foster P Carr, MD
CONTACT
6192343725
drcarr@carihealth.com
Torsten Feibig, PhD
CONTACT
torsten@carihealth.com

Principal Investigator

Charmaine Semenluk, MD
PRINCIPAL_INVESTIGATOR
Synergy Research Inc.

Study Locations (Sites)

Synergy
Lemon Grove, California, 91945
United States

Collaborators and Investigators

Sponsor: Cari Health Inc.

  • Charmaine Semenluk, MD, PRINCIPAL_INVESTIGATOR, Synergy Research Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-26
Study Completion Date2026-04

Study Record Updates

Study Start Date2024-08-26
Study Completion Date2026-04

Terms related to this study

Keywords Provided by Researchers

  • Pharmacokinetics

Additional Relevant MeSH Terms

  • Methadone Toxicity
  • Methadone Overdose
  • Pain, Chronic
  • Drug Metabolism, Poor, CYP2D6-Related
  • Metabolism Medication Toxicity