Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 to 64

Evaluating a new method for observing methadone treatment remotely

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

Run by Sonara Health · NCT06338280 · Data updated 2026-11-12

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

PhasePhase 2
Study typeInterventional
Ages18 Years to 64 Years
SexAll
Enrollment100 (estimated)
SponsorSonara Health
Industry-sponsored
Locations1 site (Chicago, Illinois)
StatusRecruiting
StartedDecember 24, 2024
Main results expectedMarch 30, 2027
Study endsApril 30, 2027
Registry record updatedMarch 27, 2026
Trial IDNCT06338280 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably not a fit

Patients who are currently involved in the criminal justice system or those treated with buprenorphine may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: Other studies have shown promise in using technology for remote monitoring in addiction treatment, suggesting potential success for this novel approach.

Who can join: the full rules

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 it's running

  • FGC Wabash
    Chicago, Illinois, United States
    Recruiting

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.