Remotely Observed Methadone Evaluation II
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sonara.
- Who it may be relevant to
- Registry conditions: Opioid Use Disorder. Basic parameters: 18 years — 64 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Remote Observed Methadone Evaluation Phase II (ROME II): Retention and Costs of Care
Overview
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.
Interventions
- Other Sonara
Sonara virtual dosing window and engagement platform
Primary outcome measures
- Retention [Time frame: 24 weeks]
- Take homes received over time [Time frame: 24 weeks]
Secondary outcome measures (5)
- Opioid cravings [Time frame: 24 weeks]
- Urine toxicology [Time frame: 24 weeks]
- Opioid withdrawal severity [Time frame: 24 weeks]
- Health-related quality of life [Time frame: 24 weeks]
- Drug Abuse Treatment Costs Analysis [Time frame: 24 weeks]
Eligibility criteria
Inclusion criteria
- Willing to participate in a randomized trial
- Able to complete study instruments and interviews
Exclusion criteria
- 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- FGC Wabash — Chicago
Identifiers
NCT: NCT06338280 · VDW002