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Remotely Observed Methadone Evaluation II

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

Who can join

Ages 18 to 64 · All sexes

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).

About the study

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.

What is being tested

• Sonara (other)

Sponsor: Sonara Health · Participants: 100 · Started: Dec 24, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06338280

Locations in the U.S.

Conditions

• Opioid Overdose

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.