drugset / Trial / NCT01713803

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

NCT01713803

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.

Timeline

Start
Primary completion
2017-05-01
Completion
2017-05-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Buprenorphine Other / unclassified
Subject Naloxone Small molecule

Indications