Remotely Observed Methadone Evaluation

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

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-25

Study Completion Date

2022-12-02

Brief Summary

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Opioid addiction, which affects 16 million individuals worldwide, can be treated using methadone, a proven and effective opioid medication for treating OUD that extends retention in care, reduces mortality, and inhibits illicit drug use. However, methadone treatment is limited to federally certified Opioid Treatment Programs (OTPs), which must meet complex regulatory requirements, and require new patients to take their dose in person six days per week, presenting significant barriers to treatment. To address these barriers, Sonara Heath has developed the Sonara software platform, which will enable OTPs to offer accelerated take-home methadone regimens while maintaining safety and diversion prevention.

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Detailed Description

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Conditions

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Opioid Use Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Interventions

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Sonara

web application facilitating asynchronous observation of methadone dosing

Intervention Type DEVICE

Other Intervention Names

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Elpida Virtual dosing window

Eligibility Criteria

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Inclusion Criteria

* Receiving methadone for the treatment of opioid use disorder

Exclusion Criteria

* Patients with \>13 take-homes
* Patients with positive toxicology results in last 30-60 days
* Patients involved with drug court ineligible for take-homes
* Patients without adequate access to technology
* Patients with \<30 days in treatment
* Patients with mental health instability
* Patients with recent diversion attempts
* Patients using buprenorphine for agonist therapy
* Patients guest dosing at another clinic during trial period

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No