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OpenTrials
Completed

NCT Number: NCT06200740

Remotely Observed Methadone Evaluation

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.

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Key information

Conditions

Opioid Use Disorder Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Adapt - Roseburg

Roseburg, Oregon, 97470, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sonara

Device

web application facilitating asynchronous observation of methadone dosing

Other names: Elpida, Virtual dosing window

Primary outcomes

  1. System Usability Scale (SUS)

    Time frame: 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 outcomes

  1. Acceptability, Appropriateness and Feasibility of Implementation Measures

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Sonara Health

Industry

Collaborators

  • Adapt Oregon
  • Oregon Health and Science University
  • Stanford University

Registry information

Official study title

Remotely Observed Methadone Evaluation (ROME)

Acronym: ROME

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 11, 2024
Registry last updated
Jan 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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