Remotely Observed Methadone Evaluation (ROME)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Opioid Use Disorder
- Sponsor
- Sonara Health
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- System Usability Scale (SUS)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief 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.
Investigators
Michael Giles
Chief Executive Officer
Sonara Health
Eligibility Criteria
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
Outcomes
Primary Outcomes
System Usability Scale (SUS)
Time Frame: two weeks
The SUS, a 10-item scale with each item rated on a 5-point scale (scored 0 to 4) with five negative statements (e.g., system is unnecessarily complex) (reverse scored) and five positive statements (e.g., system functions are well integrated), evaluated user perceptions of the system's usability. We summed scores and multiplied them by 2.5 for the total score with a range from 0 to 100 (Lewis, 2018).
Secondary Outcomes
- Acceptability, Appropriateness and Feasibility of Implementation Measures(two weeks)