Overview

Evaluation of BEMA® Buprenorphine NX for Buprenorphine Induction of Opioid Dependent Subjects

Status:
Withdrawn
Trial end date:
2017-05-01
Target enrollment:
Participant gender:
Summary
This is a randomized, double blind, placebo controlled study in opioid dependent subjects. Subjects meeting entry criteria will be treated with multiple doses of B-BNX or B-Placebo, with non-responders rescued within 6 hours. Open treatment B-BNX will be administered as follow-up therapy. Clinical efficacy assessments include the clinical opioid withdrawal scale (COWS), subject-rated assessments, and a urine drug screen.
Phase:
Phase 3
Details
Lead Sponsor:
BioDelivery Sciences International
Treatments:
Buprenorphine
Naloxone