Remotely Observed Methadone Evaluation II
ROME II
Remote Observed Methadone Evaluation Phase II (ROME II): Retention and Costs of Care
1 other identifier
interventional
100
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 22, 2024
CompletedFirst Posted
Study publicly available on registry
March 29, 2024
CompletedStudy Start
First participant enrolled
December 24, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2027
March 27, 2026
March 1, 2026
2.3 years
March 22, 2024
March 23, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Retention
Length of time the patient remains in treatment after study enrollment
24 weeks
Take homes received over time
The number of take home doses of methadone received at 4-, 12-, and 24-weeks following randomization
24 weeks
Secondary Outcomes (5)
Opioid cravings
24 weeks
Urine toxicology
24 weeks
Opioid withdrawal severity
24 weeks
Health-related quality of life
24 weeks
Drug Abuse Treatment Costs Analysis
24 weeks
Study Arms (2)
Sonara-enabled
EXPERIMENTALTreatment as usual
NO INTERVENTIONInterventions
Eligibility Criteria
You may qualify if:
- Willing to participate in a randomized trial
- Able to complete study instruments and interviews
You may not qualify if:
- Less than 18 years of age
- Pregnant or planning to be pregnant
- Currently involved in the criminal justice system
- Serious mental health problems
- Treated with buprenorphine
- Please note: The enrollment target (2.5 randomizations per week over 50 weeks) includes oversampling women and under-represented racial/ethnicity groups (i.e., at least 10 or more individuals per group who identify as Black, Hispanic, and American Indian/Alaskan Native).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sonara Healthlead
- Chestnut Health Systemscollaborator
Study Sites (1)
FGC Wabash
Chicago, Illinois, 75220, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 22, 2024
First Posted
March 29, 2024
Study Start
December 24, 2024
Primary Completion (Estimated)
March 30, 2027
Study Completion (Estimated)
April 30, 2027
Last Updated
March 27, 2026
Record last verified: 2026-03