Efficacy of BNX Sublingual Tablets Versus BNX Sublingual Film for Treatment of Opioid-Dependent Adults
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.
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
- Enrollment
- 759 participants
Conditions and interventions
Conditions
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.