Remotely Observed Methadone Evaluation II

Recruiting now · Phase 2

Conditions studied: Opioid Use Disorder

In brief

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.

Key facts

Study ID

NCT06338280

Run by

Sonara Health

People needed

100

Starts

2024-12-24

Expected to finish

2027-04-30

Last updated by the study team

2026-03-27

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Willing to participate in a randomized trial
• Able to complete study instruments and interviews

You may not qualify if…

• 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 is running

• FGC Wabash — Chicago, Illinois, United States (enrolling)

Full record on ClinicalTrials.gov

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