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NCT Number: NCT06338280

Remotely Observed Methadone Evaluation II

Methadone is an effective treatment for severe opioid use disorder (OUD), but access is limited due to the requirement of daily observed dosing by most opioid treatment programs (OTPs). Sonara Health designed a HIPAA-compliant web-application called Sonara that features integrated video dosing recording, a tamper-evident seal, and an innovative measurement-based care (MBC) framework called the Opioid Craving Visual Analogue Scale (OC-VAS) to facilitate methadone take-homes while providing evidence of appropriate use and monitoring patient outcomes. Phase II of this SBIR aims to compare Sonara against usual take-homes to assess its impact on retention in care, opioid use, patient outcomes, and costs of care.

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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–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

FGC Wabash

Chicago, Illinois, 75220, United States

Location status: Recruiting

Location contact

Michael Dennis, PhD

CONTACT

[email protected]

888-924-3786

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Willing to participate in a randomized trial
  • Able to complete study instruments and interviews

Exclusion criteria

  • Less than 18 years of age
  • Pregnant or planning to be pregnant
  • Currently involved in the criminal justice system
  • Serious mental health problems
  • Treated with buprenorphine

Please note: The enrollment target (2.5 randomizations per week over 50 weeks) includes oversampling women and under-represented racial/ethnicity groups (i.e., at least 10 or more individuals per group who identify as Black, Hispanic, and American Indian/Alaskan Native).

Treatment and study plan

Sonara

Other

Sonara virtual dosing window and engagement platform

Primary outcomes

  1. Retention

    Time frame: 24 weeks

    Length of time the patient remains in treatment after study enrollment

  2. Take homes received over time

    Time frame: 24 weeks

    The number of take home doses of methadone received at 4-, 12-, and 24-weeks following randomization

Secondary outcomes

  1. Opioid cravings

    Time frame: 24 weeks

    Opioid craving visual analog scale (OC-VAS), a single-item, patient-reported outcome measure that captures the severity of cravings, reported on a 0-100 scale

  2. Urine toxicology

    Time frame: 24 weeks

    A qualitative test that detects the presence of commonly used illicit substances or their metabolites in a urine sample

  3. Opioid withdrawal severity

    Time frame: 24 weeks

    Subjective Opioid Withdrawal Scale (SOWS) - a self-administered scale for grading opioid withdrawal symptoms. It contains 16 symptoms whose intensity the patient rates on a scale of 0 (not at all) to 4 (extremely)

  4. Health-related quality of life

    Time frame: 24 weeks

    CDC (Health-related quality of life) HRQOL-14 "Healthy Days Measure" - 14-item questionnaire that assesses an individual's perceived physical and mental health status over the past 30 days, including self-rated health, recent days of poor physical or mental health, and activity limitations

  5. Drug Abuse Treatment Costs Analysis

    Time frame: 24 weeks

    A standardized method for estimating the economic costs of substance abuse treatment programs, including both direct costs (such as personnel, supplies, and facilities) and indirect costs (such as overhead and administrative expenses)

Sponsors and collaborators

Lead sponsor

Sonara Health

Industry

Collaborators

  • Chestnut Health Systems

Registry information

Official study title

Remote Observed Methadone Evaluation Phase II (ROME II): Retention and Costs of Care

Acronym: ROME II

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Mar 29, 2024
Registry last updated
Mar 27, 2026

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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