Trials / Withdrawn
WithdrawnNCT01713803
Evaluation of BEMA® Buprenorphine NX for Buprenorphine Induction of Opioid Dependent Subjects
- Status
- Withdrawn
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- BioDelivery Sciences International · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Buprenorphine and naloxone |
Timeline
- Primary completion
- 2017-05-01
- Completion
- 2017-05-01
- First posted
- 2012-10-25
- Last updated
- 2017-05-04
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01713803. Inclusion in this directory is not an endorsement.