Remotely Observed Methadone Evaluation
ROME
2 other identifiers
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 25, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 2, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 2, 2022
CompletedFirst Submitted
Initial submission to the registry
December 8, 2023
CompletedFirst Posted
Study publicly available on registry
January 11, 2024
CompletedJanuary 11, 2024
December 1, 2023
2 months
December 8, 2023
December 30, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Acceptability, Appropriateness and Feasibility of Implementation Measures
two weeks
Interventions
web application facilitating asynchronous observation of methadone dosing
Eligibility Criteria
You may qualify if:
- Receiving methadone for the treatment of opioid use disorder
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sonara Healthlead
- Oregon Health and Science Universitycollaborator
- Stanford Universitycollaborator
- Adapt Oregoncollaborator
Study Sites (1)
Adapt - Roseburg
Roseburg, Oregon, 97470, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief Executive Officer
Study Record Dates
First Submitted
December 8, 2023
First Posted
January 11, 2024
Study Start
September 25, 2022
Primary Completion
December 2, 2022
Study Completion
December 2, 2022
Last Updated
January 11, 2024
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share