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

NCT01908842 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 759

Last updated 2017-05-10

Study results available
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Summary

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.

Conditions

  • Opioid Dependence, on Agonist Therapy

Interventions

DRUG

BNX sublingual tablets

Buprenorphine/naloxone sublingual tablets

DRUG

BNX sublingual film

Buprenorphine/naloxone sublingual film

DRUG

Buprenorphine

Buprenorphine sublingual tablets

Sponsors & Collaborators

  • Worldwide Clinical Trials

    collaborator OTHER

  • Orexo AB

    lead INDUSTRY

Principal Investigators

  • Erik Gunderson · University of Virginia, PO Box 800623, Charlottesville, VA 22911

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2014-04-30
Completion
2014-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01908842 on ClinicalTrials.gov