NCT06338280

Remotely Observed Methadone Evaluation II

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Sonara Health · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Opioid Use Disorder

Interventions

Type	Name	Description
OTHER	Sonara	Sonara virtual dosing window and engagement platform

Timeline

• Start date: 2024-12-24
• Primary completion: 2027-03-30
• Completion: 2027-04-30
• First posted: 2024-03-29
• Last updated: 2026-03-27

Locations

1 site across 1 country: United States