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Remotely Observed Methadone Evaluation II

RecruitingPhase 2Ages 18 Years - 64 YearsAllSonara Health
NCT06338280 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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).
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What it tests

  • Sonara
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Where

1 site
FGC Wabash
Chicago, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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