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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2012 by BioDelivery Sciences International
Sponsor:
Information provided by:
BioDelivery Sciences International
ClinicalTrials.gov Identifier:
NCT01713803
First received: October 19, 2012
Last updated: October 24, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Opioid Dependency
Drug: Buprenorphine and naloxone
Phase 3

Study Type: Interventional

Resource links provided by NLM:


Further study details as provided by BioDelivery Sciences International:

Primary Outcome Measures:
  • The mean change in clinical opioid withdrawal scale (COWS) total score from Baseline to 6 hours following the initial dose

Secondary Outcome Measures:
  • The percentage of subjects with a negative result on the urine drug screen at Day 7
  • The percentage of subjects with a clinical opioid withdrawal scale (COWS) total score ≤4 at 6 hours after the initial study drug dose

Arms Assigned Interventions
Placebo Comparator: Sugar pill Drug: Buprenorphine and naloxone
Experimental: buprenorphine and nalaxone Drug: Buprenorphine and naloxone

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent obtained prior to any study procedure being performed
  • Subject is a male or non-lactating female with a negative urine pregnancy test
  • Subject is aged 18 to 65 years, inclusive
  • Current diagnosis of opioid dependence or addiction per the Diagnostic and Statistical Manual of Mental Disorders - 4th edition (text revision) (DSM-IV-TR) criteria including physical dependence on opioids
  • Daily short-acting opiate use of at least 60 mg morphine equivalent no opioid use for at least 12 hours prior to Screening with positive opiate result on urine drug screen
  • Clinical opioid withdrawal scale (COWS) score ≥9
  • Subject is in good general health in the judgment of the Investigator as determined from the physical and oral examination findings.

Exclusion Criteria:

  • Use of a long-acting opioid within the last 72 hours
  • Use of an investigational drug or device within the last 30 days
  • History of hypersensitivity, allergy, or intolerance to buprenorphine, naloxone, or related drugs
  • Immediate suicidal risk, as determined by meeting any of the following:

    1. History of suicidal ideation ≤ 3 months prior to Baseline with a score of 4 (intent to act) or 5 (specific plan and intent) on the eC-SSRS
    2. History of suicidal behavior ≤1 year prior to Baseline (actual attempt, interrupted attempt, aborted attempt and/or preparatory acts/behavior) on the eC-SSRS
  • A history or current evidence of any clinically significant disorder or any other condition which in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01713803

Contacts
Contact: Andrew Finn, PharmD 919-582-9050 AFinn@BDSI.com
Contact: Tim Warneke, MS 919-582-9050 TWarneke@BDSI.com

Locations
United States, Alabama
Not yet recruiting
Birmingham, Alabama, United States, 35215
Sponsors and Collaborators
BioDelivery Sciences International
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01713803     History of Changes
Other Study ID Numbers: BNX-350
Study First Received: October 19, 2012
Last Updated: October 24, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Narcotics
Narcotic Antagonists
Buprenorphine
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 22, 2014