Remotely Observed Methadone Evaluation (ROME)

Remotely Observed Methadone Evaluation (ROME)

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.

Study Overview

• Status: Completed
• Conditions: Opioid Use Disorder
• Intervention / Treatment: Device: Sonara

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Roseburg, Oregon, United States, 97470
      • Adapt - Roseburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
System Usability Scale (SUS)	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).	two weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability, Appropriateness and Feasibility of Implementation Measures	Acceptability Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM) are single factor 4-item scales scored 1 to 5 and summed with test-retest reliabilities of 0.73 to 0.88 (Weiner et al., 2017). Scores for each of the three dimensions have a potential range of 4 to 20 with higher scores suggesting better implementation potential.	two weeks

Collaborators and Investigators

• Sponsor: Sonara Health
• Collaborators: Oregon Health and Science University; Stanford University; Adapt Oregon

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2022
• Primary Completion (Actual): December 2, 2022
• Study Completion (Actual): December 2, 2022

Study Registration Dates

• First Submitted: December 8, 2023
• First Submitted That Met QC Criteria: December 30, 2023
• First Posted (Actual): January 11, 2024

Study Record Updates

• Last Update Posted (Actual): January 11, 2024
• Last Update Submitted That Met QC Criteria: December 30, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders
• Other Study ID Numbers: VDW001; R43DA056259 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No