Remote Observed Methadone Evaluation Phase II (ROME II): Retention and Costs of Care
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Opioid Use Disorder
- Sponsor
- Sonara Health
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Retention
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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).
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Retention
Time Frame: 24 weeks
Length of time the patient remains in treatment after study enrollment
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
- Urine toxicology(24 weeks)
- Opioid cravings(24 weeks)
- Health-related quality of life(24 weeks)
- Opioid withdrawal severity(24 weeks)
- Drug Abuse Treatment Costs Analysis(24 weeks)