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Completed Phase 4 Interventional Results available

Multi-Center, Open-Label, 24-Week Study of OX219 Safety and Efficacy for Maintenance Treatment of Opioid Dependence

ClinicalTrials.gov ID: NCT01903005

Public ClinicalTrials.gov record NCT01903005. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 17, 2026, 7:38 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Multi-center, Open-Label, 24-Week, Follow-Up Study to Assess Safety, Efficacy, and Treatment Adherence For Maintenance Treatment of Opioid Dependence With OX219

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this study was to assess safety, efficacy, and treatment retention following extended treatment with OX219, a higher-bioavailability buprenorphine/naloxone (BNX) sublingual tablet formulation in opioid-dependent patients who completed 1 of 2 primary efficacy and safety studies of OX219.

Study identification

NCT ID
NCT01903005
Recruitment status
Completed
Study type
Interventional
Phase
Phase 4
Lead sponsor
Orexo AB
Industry
Enrollment
668 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 65 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 2013 (Type not available)
Primary completion
Sep 2014 (Actual)
Completion
Sep 2014 (Actual)
Last update posted
Oct 28, 2015

2013 – 2014

United States locations

U.S. sites
28
U.S. states
17
U.S. cities
28
Facility City State ZIP Site status
Not listed Jefferson County Alabama — —
Not listed Marion County Alabama — —
Not listed Winston County Alabama — —
Not listed Maricopa County Arizona — —
Not listed Los Angeles County California — —
Not listed San Diego County California — —
Not listed Broward County Florida — —
Not listed Columbia County Florida — —
Not listed Duval County Florida — —
Not listed Jacksonville Metropolitan Area Florida — —
Not listed Miami-Dade County Florida — —
Not listed Orlando Metropolitan Area Florida — —
Not listed Osceola County Florida — —
Not listed Palm Beach County Florida — —
Not listed DeKalb County Georgia — —
Not listed Chicago Metropolitan Area Illinois — —
Not listed Baltimore County Maryland — —
Not listed Bristol County Massachusetts — —
Not listed Rankin County Mississippi — —
Not listed Saint Louis Metropolitan Area Missouri — —
Not listed Warren County New Jersey — —
Not listed Oklahoma County Oklahoma — —
Not listed Portland Metropolitan Area Oregon — —
Not listed Delaware County Pennsylvania — —
Not listed Philadelphia County Pennsylvania — —
Not listed Charleston County South Carolina — —
Not listed Salt Lake County Utah — —
Not listed Benton County Washington — —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01903005, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 28, 2015 · Synced Oct 17, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01903005 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →