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NCT06338280 · ClinicalTrials.gov registry record · Phase 2

Remotely Observed Methadone Evaluation II

A Phase 2 study of Opioid Use Disorder, sponsored by Sonara Health.

Recruiting
Registry status
Phase 2
Development phase
100
Enrollment target
1
Study location

NCT06338280 is a Phase 2 study of Opioid Use Disorder that is actively recruiting participants, run by Sonara Health. The registered enrollment target is 100 participants, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT06338280, a Phase 2 study of Opioid Use Disorder, is actively recruiting participants, sponsored by Sonara Health.

RECRUITING
Registry status
Phase 2
Development phase
100 participants
Enrollment target
1
Study location

Study 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.

Conditions Studied

Opioid Use Disorder

Interventions

  • OTHER Sonara

Study Locations (1)

Illinois

  • FGC Wabash - Chicago

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2024-12-24
Est. Completion 2027-04-30
Phase Phase 2

Sponsor

Sonara Health

2 total trials

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What the Registry Record Tells You About NCT06338280

The ClinicalTrials.gov registry entry for NCT06338280 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (98% lower). The listed sponsor is Sonara Health, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Opioid Use Disorder appearing as the primary indexed condition, and to 1 intervention - of which Sonara is the first listed.

NCT06338280 reports 1 study location spanning 1 distinct geographic area - top geographies include Illinois.

Frequently Asked Questions

What is clinical trial NCT06338280 about?

NCT06338280 is a clinical study titled "Remotely Observed Methadone Evaluation II". 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 recor...

What is the current status of trial NCT06338280?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2024-12-24. Estimated completion is 2027-04-30.

What conditions does trial NCT06338280 study?

This clinical trial studies the following conditions: Opioid Use Disorder.

What interventions are being tested in trial NCT06338280?

The interventions under investigation include: Sonara (OTHER).

Who is sponsoring clinical trial NCT06338280?

This trial is sponsored by Sonara Health, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06338280 being conducted?

This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.