NCT01848054

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

A Randomized, Blinded, Active-controlled Non-inferiority Study of the Efficacy and Safety of OX219 for the Induction of Treatment of Opioid Dependence

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 313 (actual)
• Sponsor: Orexo AB · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This was a prospective, randomized, multicenter, blinded, parallel-group, active-controlled, non-inferiority study conducted at 13 sites within the US. Eligible patients participated in 8 treatment visits on Days 1, 2, 3, 4, 8, 15, 22, and 29. Effectiveness of treatment was assessed as follows: * Retention in treatment at Day 3 * Clinician and patient assessments of opioid withdrawal symptoms * Assessment opioid cravings

Conditions

• Opioid-Related Disorders
• Opiate Dependence

Interventions

Type	Name	Description
DRUG	Buprenorphine/naloxone sublingual tablets	Advanced-formulation buprenorphine/naloxone sublingual tablets
DRUG	Buprenorphine	Buprenorphine sublingual tablets

Timeline

• Start date: 2013-06-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2013-05-07
• Last updated: 2017-05-10
• Results posted: 2015-06-24

Locations

14 sites across 1 country: United States