Conditions: Opioid-Related Disorders Opiate Dependence
Keywords: opioid dependence, buprenorphine/naloxone, sublingual
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 313
Healthy volunteers: no

Brief 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

Arms:
arm 1: Day 1-2 (Blinded Induction): BNX sublingual tablets

Day 3-28 (Open-label Maintenance): BNX sublingual tablets arm 2: Day 1-2 (Blinded Induction): Generic buprenorphine sublingual tablets

Day 3-28 (Open-label Maintenance): BNX sublingual tablets

Interventions: intervention 1: Buprenorphine/naloxone sublingual tablets intervention 2: Buprenorphine
Intervention descriptions: intervention 1: Advanced-formulation buprenorphine/naloxone sublingual tablets intervention 2: Buprenorphine sublingual tablets

Protocol document: