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Remotely Observed Methadone Evaluation II (ROME II)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT06338280
Recruitment Status : Not yet recruiting
First Posted : March 29, 2024
Last Update Posted : April 2, 2024
Information provided by (Responsible Party):
Sonara Health

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Opioid Use Disorder Other: Sonara Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Remote Observed Methadone Evaluation Phase II (ROME II): Retention and Costs of Care
Estimated Study Start Date : May 1, 2024
Estimated Primary Completion Date : May 1, 2027
Estimated Study Completion Date : May 1, 2027

Arm Intervention/treatment
Experimental: Sonara-enabled Other: Sonara
Sonara virtual dosing window and engagement platform

No Intervention: Treatment as usual

Primary Outcome Measures :
  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 Outcome Measures :
  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)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

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Responsible Party: Sonara Health Identifier: NCT06338280    
Other Study ID Numbers: VDW002
First Posted: March 29, 2024    Key Record Dates
Last Update Posted: April 2, 2024
Last Verified: March 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Opioid-Related Disorders
Narcotic-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders