Remotely Observed Methadone Evaluation II (ROME II)

Sonara Health

Status and phase

Enrolling

Phase 2

Conditions

Opioid Use Disorder

Treatments

Other: Sonara

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06338280

VDW002

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).