RECRUITING

Remotely Observed Methadone Evaluation II

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

Methadone is an effective treatment for severe opioid use disorder (OUD), but access is limited due to the requirement of daily observed dosing by most opioid treatment programs (OTPs). Sonara Health designed a HIPAA-compliant web-application called Sonara that features integrated video dosing recording, a tamper-evident seal, and an innovative measurement-based care (MBC) framework called the Opioid Craving Visual Analogue Scale (OC-VAS) to facilitate methadone take-homes while providing evidence of appropriate use and monitoring patient outcomes. Phase II of this SBIR aims to compare Sonara against usual take-homes to assess its impact on retention in care, opioid use, patient outcomes, and costs of care.

Official Title

Remote Observed Methadone Evaluation Phase II (ROME II): Retention and Costs of Care

Quick Facts

Study Start:2024-12-24
Study Completion:2027-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06338280

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
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Willing to participate in a randomized trial
  2. * Able to complete study instruments and interviews
  1. * Less than 18 years of age
  2. * Pregnant or planning to be pregnant
  3. * Currently involved in the criminal justice system
  4. * Serious mental health problems
  5. * Treated with buprenorphine

Contacts and Locations

Study Locations (Sites)

FGC Wabash
Chicago, Illinois, 75220
United States

Collaborators and Investigators

Sponsor: Sonara Health

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 Date2024-12-24
Study Completion Date2027-04-30

Study Record Updates

Study Start Date2024-12-24
Study Completion Date2027-04-30

Terms related to this study

Additional Relevant MeSH Terms

  • Opioid Use Disorder