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RecruitingPhase 2

Remotely Observed Methadone Evaluation II

Sonara Health · with Chestnut Health Systems · NCT06338280

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–64 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
100
US sites recruiting
1
Study start
December 24, 2024
Record last updated
March 27, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is 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.

Being studied: Sonara

Conditions: Opioid Use Disorder

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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).

Recruiting US locations

  • FGC Wabash

    Chicago, IL 75220

    Site contact: Michael Dennis, PhD · 888-924-3786 · mdennis@chestnut.org

Remotely Observed Methadone Evaluation II (NCT06338280) | Bored Studies