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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 Oct 20, 2026, 4:47 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

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
Aug 2013 (Type not available)
Primary completion
Apr 2014 (Actual)
Completion
Apr 2014 (Actual)
Last update posted
May 10, 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 10, 2017 · Synced Oct 20, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01908842 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →