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RECRUITING
NCT06338280
PHASE2

Remotely Observed Methadone Evaluation II

Sponsor: Sonara Health

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 64 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2024-12-24

Completion Date

2027-04-30

Last Updated

2026-03-27

Healthy Volunteers

No

Interventions

OTHER

Sonara

Sonara virtual dosing window and engagement platform

Locations (1)

FGC Wabash

Chicago, Illinois, United States