Conditions: Opioid Dependence, on Agonist Therapy
Keywords: Opioid, Dependence, agonist, Buprenorphine, Naloxone
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 668
Healthy volunteers: no

Brief 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.

Detailed description:
This was a multicenter, open-label, uncontrolled, single-arm, 24-week, extension study to assess safety, efficacy, and treatment retention during maintenance treatment.

Eligible patients had completed 1 of 2 primary efficacy and safety studies of the higher-bioavailability BNX sublingual tablet formulation (primary study OX219-006 \[NCT01908842\] or OX219-007 \[NCT01848054\]). The total duration of study treatment was 24 weeks.

Arms:
arm 1: Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.

Interventions: intervention 1: Higher bioavailability BNX sublingual tablets
Intervention descriptions: intervention 1: Once daily, open-label treatment with higher bioavailability BNX sublingual tablets for 24 weeks

Protocol document: