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Multi-Center, Open-Label, 24-Week Study of OX219 Safety and Efficacy for Maintenance Treatment of Opioid Dependence

NCT01903005 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 668

Last updated 2015-10-28

Study results available
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Summary

The purpose of this study was to assess safety, efficacy, and treatment retention following extended treatment with OX219, a higher-bioavailability buprenorphine/naloxone (BNX) sublingual tablet formulation in opioid-dependent patients who completed 1 of 2 primary efficacy and safety studies of OX219.

Conditions

  • Opioid Dependence, on Agonist Therapy

Interventions

DRUG

Higher bioavailability BNX sublingual tablets

Once daily, open-label treatment with higher bioavailability BNX sublingual tablets for 24 weeks

Sponsors & Collaborators

  • Worldwide Clinical Trials

    collaborator OTHER

  • Orexo AB

    lead INDUSTRY

Principal Investigators

  • Kent Hoffman · TRY Research, 406 Lake Howell Road, Maitland, Florida 32751

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • United States

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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 NCT01903005 on ClinicalTrials.gov