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

NCT01848054 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 313

Last updated 2017-05-10

Study results available
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Summary

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.

Conditions

  • Opioid-Related Disorders
  • Opiate Dependence

Interventions

DRUG

Buprenorphine/naloxone sublingual tablets

Advanced-formulation buprenorphine/naloxone sublingual tablets

DRUG

Buprenorphine

Buprenorphine sublingual tablets

Sponsors & Collaborators

  • Worldwide Clinical Trials

    collaborator OTHER

  • Orexo AB

    lead INDUSTRY

Principal Investigators

  • Lynn Webster · Life Tree Pain Clinic, 3838 S 700 E Suite 200, Salt Lake City, UT 84106

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2014-01-31
Completion
2014-01-31

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 NCT01848054 on ClinicalTrials.gov