NCT06338280 Remotely Observed Methadone Evaluation II
| NCT ID | NCT06338280 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Sonara Health |
| Condition | Opioid Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-12-24 |
| Primary Completion | 2027-03-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 100 participants in total. It began in 2024-12-24 with a primary completion date of 2027-03-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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).
Frequently Asked Questions
Who can join the NCT06338280 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 64 Years, studying Opioid Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06338280 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06338280 currently recruiting?
Yes, NCT06338280 is actively recruiting participants. Visit ClinicalTrials.gov or contact Sonara Health to inquire about joining.
Where is the NCT06338280 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT06338280 clinical trial?
NCT06338280 is sponsored by Sonara Health. The trial plans to enroll 100 participants.