drugset / Trial / NCT01713803
Evaluation of BEMA® Buprenorphine NX for Buprenorphine Induction of Opioid Dependent Subjects
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Buprenorphine | Other / unclassified | — | — |
| Subject | Naloxone | Small molecule | — | — |