Remotely Observed Methadone Evaluation (ROME)

Sonara Health

Status: Completed

Conditions: Opioid Use Disorder

Treatments: Device: Sonara

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06200740

R43DA056259 (U.S. NIH Grant/Contract)

VDW001

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Receiving methadone for the treatment of opioid use disorder

Exclusion criteria

• Patients with >13 take-homes
• Patients with positive toxicology results in last 30-60 days
• Patients involved with drug court ineligible for take-homes
• Patients without adequate access to technology
• Patients with <30 days in treatment
• Patients with mental health instability
• Patients with recent diversion attempts
• Patients using buprenorphine for agonist therapy
• Patients guest dosing at another clinic during trial period

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)