Remotely Observed Methadone Evaluation II

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Sonara Health
Study ID
NCT06338280
Phase
PHASE2
Status
Recruiting
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Conditions

  • Opioid Use Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Not accepted

Interventions

  • Sonara — OTHER
    Sonara virtual dosing window and engagement platform

Study Details

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.

Key Dates

Start date
Dec 24, 2024
Status verified
Mar 2026
Primary completion
Mar 30, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Sonara-enabled
  • No Intervention: Treatment as usual

Primary Outcome Measure

Retention [ Time Frame: 24 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
FGC WabashChicagoIllinois75220
Michael Dennis, PhD
[email protected]
888-924-3786

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By research site
FGC Wabash· Chicago, IL

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