NCT06200740

Remotely Observed Methadone Evaluation

Remotely Observed Methadone Evaluation (ROME)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Sonara Health · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Opioid addiction, which affects 16 million individuals worldwide, can be treated using methadone, a proven and effective opioid medication for treating OUD that extends retention in care, reduces mortality, and inhibits illicit drug use. However, methadone treatment is limited to federally certified Opioid Treatment Programs (OTPs), which must meet complex regulatory requirements, and require new patients to take their dose in person six days per week, presenting significant barriers to treatment. To address these barriers, Sonara Heath has developed the Sonara software platform, which will enable OTPs to offer accelerated take-home methadone regimens while maintaining safety and diversion prevention.

Conditions

• Opioid Use Disorder

Interventions

Type	Name	Description
DEVICE	Sonara	web application facilitating asynchronous observation of methadone dosing

Timeline

• Start date: 2022-09-25
• Primary completion: 2022-12-02
• Completion: 2022-12-02
• First posted: 2024-01-11
• Last updated: 2024-01-11

Locations

1 site across 1 country: United States