NCT06338280PHASE2Recruiting

Remotely Observed Methadone Evaluation II

Sonara Health

Start Date

12/24/2024

Completion Date

4/30/2027

Summary

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.

Eligibility Criteria

Age Range: 18 years to 64 years

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).

Interventions

OTHER

Sonara

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Conditions

Opioid Use Disorder

Locations

FGC Wabash

Chicago, Illinois 75220

United States