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Completed Phase 3 Interventional Results available

Study to Assess Efficacy and Safety of BNX Sublingual Tablets for the Induction of Treatment of Opioid Dependence

ClinicalTrials.gov ID: NCT01848054

Public ClinicalTrials.gov record NCT01848054. 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 23, 2026, 6:56 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 Randomized, Blinded, Active-controlled Non-inferiority Study of the Efficacy and Safety of OX219 for the Induction of Treatment of Opioid Dependence

Brief summary

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

The purpose of the study was to assess the efficacy of induction treatment with buprenorphine/naloxone (BNX) sublingual tablet s compared with induction treatment with buprenorphine only. The hypothesis is that starting directly on OX219 works equally well (e.g. not significantly worse) as starting on buprenorphine only and switching to OX219 on Day 3.

Study identification

NCT ID
NCT01848054
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Orexo AB
Industry
Enrollment
313 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 2013 (Type not available)
Primary completion
Jan 2014 (Actual)
Completion
Jan 2014 (Actual)
Last update posted
May 10, 2017

2013 – 2014

United States locations

U.S. sites
14
U.S. states
10
U.S. cities
14
Facility City State ZIP Site status
Not listed Birmingham Alabama — —
Not listed Haleyville Alabama — —
Not listed National City California — —
Not listed Oceanside California — —
Not listed Jacksonville Florida — —
Not listed Maitland Florida — —
Not listed North Miami Florida — —
Not listed Baltimore Maryland — —
Not listed Fall River Massachusetts — —
Not listed Flowood Mississippi — —
Not listed Philadelphia Pennsylvania — —
Not listed Charleston South Carolina — —
Not listed Houston Texas — —
Not listed Salt Lake City Utah — —

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 NCT01848054, 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 May 10, 2017 · Synced Oct 23, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01848054 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →