Remotely Observed Methadone Evaluation

Opioid Use Disorder Clinical Trial

— ROME  

Official title:

Remotely Observed Methadone Evaluation (ROME)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06200740
• Other study ID #: VDW001
• Secondary ID: R43DA056259
• Status: Completed
• Phase: N/A
• Start date: September 25, 2022
• Est. completion date: December 2, 2022

Study information

• Verified date: December 2023
• Source: Sonara Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2, 2022
• Est. primary completion date: December 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Opioid Use Disorder
• Opioid-Related Disorders

Intervention

Device:
• Sonara
web application facilitating asynchronous observation of methadone dosing

Locations

Country	Name	City	State
United States	Adapt - Roseburg	Roseburg	Oregon

Sponsors (4)

Lead Sponsor	Collaborator
Sonara Health	Adapt Oregon, Oregon Health and Science University, Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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