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Completed Phase 3 Interventional Results available

Efficacy of BNX Sublingual Tablets Versus BNX Sublingual Film for Treatment of Opioid-Dependent Adults

ClinicalTrials.gov ID: NCT01908842

Public ClinicalTrials.gov record NCT01908842. 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, 2:58 AM EDT

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

Official title

Induction, STabilization, Adherence, and Retention Trial (ISTART) - A Randomized, Non-inferiority, Multicenter Study to Assess Early Treatment Efficacy of OX219 Versus SUBOXONE Film and to Explore Switching Between Treatments

Brief summary

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

The purpose of this study was to assess retention in treatment after induction with buprenorphine/naloxone (BNX) sublingual tablets compared with generic buprenorphine and after stabilization with BNX sublingual tablets compared with BNX film. Secondary objectives included assessment of treatment effects on opioid withdrawal symptoms, opioid cravings, and safety.

Study identification

NCT ID
NCT01908842
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Orexo AB
Industry
Enrollment
759 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 31, 2013
Primary completion
Mar 31, 2014
Completion
Mar 31, 2014
Last update posted
May 9, 2017

2013 – 2014

United States locations

U.S. sites
36
U.S. states
22
U.S. cities
36
Facility City State ZIP Site status
Not listed Baldwin County Alabama
Not listed Houston County Alabama
Not listed Maricopa Arizona
Not listed Beverly Hills California
Not listed Los Angeles County California
Not listed Riverside County California
Not listed San Diego County California
Not listed Broward County Florida
Not listed Colombia County Florida
Not listed Duval County Florida
Not listed Greater Metro Orlando Florida
Not listed Lake County Florida
Not listed Miami-Dade County Florida
Not listed Osceola County Florida
Not listed Palm Beach County Florida
Not listed DeKalb County Georgia
Not listed Chicagoland Illinois
Not listed Johnson County Kansas
Not listed Kenton County Kentucky
Not listed Caddo Parish Louisiana
Not listed Baltimore County Maryland
Not listed Bristol County Massachusetts
Not listed Saint Louis Metro Area Missouri
Not listed Camden County New Jersey
Not listed Warren County New Jersey
Not listed Warren County Ohio
Not listed Oklahoma County Oklahoma
Not listed Portland Metropolitan Area Oregon
Not listed Allegheny County Pennsylvania
Not listed Delaware County Pennsylvania
Not listed Philadelphia County Pennsylvania
Not listed Charleston County South Carolina
Not listed Dallas County Texas
Not listed Salt Lake County Utah
Not listed Charlottesville Metropolitan Area Virginia
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 NCT01908842, 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 9, 2017 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01908842 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →