Remotely Observed Methadone Evaluation

Not Applicable

Completed

• Conditions: Opioid Use Disorder

• Registration Number: NCT06200740
• Lead Sponsor: Sonara Health

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-25
• Primary Completion: 2022-12-02
• Study Completion: 2022-12-02
• Status Verified: 2023-12
• Study First Submitted: 2023-12-08
• Study First Submitted QC: 2023-12-30
• Last Update Submitted: 2023-12-30
• Study First Posted: 2024-01-11
• Last Update Posted: 2024-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Adapt - Roseburg; 🇺🇸 Roseburg, Oregon, United States