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

Primary Purpose

Opioid Dependence

Status
Withdrawn
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Buprenorphine and naloxone
Sponsored by
BioDelivery Sciences International
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional trial for Opioid Dependence

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Sugar pill

buprenorphine and nalaxone

Arm Description

Outcomes

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

Full Information

First Posted
October 19, 2012
Last Updated
May 2, 2017
Sponsor
BioDelivery Sciences International
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1. Study Identification

Unique Protocol Identification Number
NCT01713803
Brief Title
Evaluation of BEMA® Buprenorphine NX for Buprenorphine Induction of Opioid Dependent Subjects
Official Title
Evaluation of BEMA® Buprenorphine NX for Buprenorphine Induction of Opioid Dependent Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Withdrawn
Why Stopped
FDA did not require a clinical trial for indication.
Study Start Date
undefined (undefined)
Primary Completion Date
May 1, 2017 (Actual)
Study Completion Date
May 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioDelivery Sciences International

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Dependence

7. Study Design

Study Phase
Phase 3
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sugar pill
Arm Type
Placebo Comparator
Arm Title
buprenorphine and nalaxone
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Buprenorphine and naloxone
Primary Outcome Measure Information:
Title
The mean change in clinical opioid withdrawal scale (COWS) total score from Baseline to 6 hours following the initial dose
Secondary Outcome Measure Information:
Title
The percentage of subjects with a negative result on the urine drug screen at Day 7
Title
The percentage of subjects with a clinical opioid withdrawal scale (COWS) total score ≤4 at 6 hours after the initial study drug dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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 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
Facility Information:
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35215
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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