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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 Sep 2, 2026, 4:46 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
Jun 30, 2013
Primary completion
Aug 31, 2014
Completion
Aug 31, 2014
Last update posted
Oct 27, 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 27, 2015 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01903005 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →