Opioid Use Disorder
Conditions
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.
Interventions
DEVICESonara
web application facilitating asynchronous observation of methadone dosing
Sponsors
Oregon Health and Science University
Stanford University
Adapt Oregon
Sonara Health
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| System Usability Scale (SUS) | 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
| Measure | Time frame | Description |
|---|---|---|
| Acceptability, Appropriateness and Feasibility of Implementation Measures | two weeks | 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. |
Countries
United States
Outcome results
None listed