Evaluating a new method for observing methadone treatment remotely
Remote Observed Methadone Evaluation Phase II (ROME II): Retention and Costs of Care
PHASE2 · Sonara Health · NCT06338280
This study tests a new online tool called Sonara to see if it can help people with opioid use disorder stick to their methadone treatment better than the usual methods.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Sponsor | Sonara Health (industry) |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT06338280 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a web-based application called Sonara, designed to facilitate remote observation of methadone dosing for patients with opioid use disorder. The study compares the Sonara system to traditional observed dosing methods to assess its impact on patient retention, opioid use, and overall healthcare costs. Participants will be randomly assigned to either the Sonara group or the usual care group, with a focus on measuring patient outcomes through innovative monitoring techniques. The trial aims to improve access to methadone treatment while ensuring compliance and safety.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are willing to participate in a randomized trial for opioid use disorder treatment.
Not a fit: Patients who are currently involved in the criminal justice system or those treated with buprenorphine may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance access to methadone treatment for patients with opioid use disorder, leading to better retention and outcomes.
How similar studies have performed: Other studies have shown promise in using technology for remote monitoring in addiction treatment, suggesting potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Chicago, Illinois
- FGC Wabash — Chicago, Illinois, United States (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Opioid Use Disorder