Remotely Observed Methadone Evaluation II

NCT ID: NCT06338280

Last Updated: 2025-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-24

Study Completion Date

2027-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Opioid Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Sonara-enabled

Group Type EXPERIMENTAL

Sonara

Intervention Type OTHER

Sonara virtual dosing window and engagement platform

Treatment as usual

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Sonara

Sonara virtual dosing window and engagement platform

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chestnut Health Systems

OTHER

Sponsor Role collaborator

Sonara Health

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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FGC Wabash

Chicago, Illinois, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Michael Dennis, PhD

Role: primary

888-924-3786

Other Identifiers

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VDW002

Identifier Type: -

Identifier Source: org_study_id

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