<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01713803</url>
  </required_header>
  <id_info>
    <org_study_id>BNX-350</org_study_id>
    <nct_id>NCT01713803</nct_id>
  </id_info>
  <brief_title>Evaluation of BEMA® Buprenorphine NX for Buprenorphine Induction of Opioid Dependent Subjects</brief_title>
  <official_title>Evaluation of BEMA® Buprenorphine NX for Buprenorphine Induction of Opioid Dependent Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>BioDelivery Sciences International</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>BioDelivery Sciences International</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized, double blind, placebo controlled study in opioid dependent subjects.&#xD;
      Subjects meeting entry criteria will be treated with multiple doses of B-BNX or B-Placebo,&#xD;
      with non-responders rescued within 6 hours. Open treatment B-BNX will be administered as&#xD;
      follow-up therapy. Clinical efficacy assessments include the clinical opioid withdrawal scale&#xD;
      (COWS), subject-rated assessments, and a urine drug screen.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    FDA did not require a clinical trial for indication.&#xD;
  </why_stopped>
  <completion_date type="Actual">May 1, 2017</completion_date>
  <primary_completion_date type="Actual">May 1, 2017</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <primary_outcome>
    <measure>The mean change in clinical opioid withdrawal scale (COWS) total score from Baseline to 6 hours following the initial dose</measure>
  </primary_outcome>
  <secondary_outcome>
    <measure>The percentage of subjects with a negative result on the urine drug screen at Day 7</measure>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The percentage of subjects with a clinical opioid withdrawal scale (COWS) total score ≤4 at 6 hours after the initial study drug dose</measure>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Opioid Dependence</condition>
  <arm_group>
    <arm_group_label>Sugar pill</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>buprenorphine and nalaxone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Buprenorphine and naloxone</intervention_name>
    <arm_group_label>Sugar pill</arm_group_label>
    <arm_group_label>buprenorphine and nalaxone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed informed consent obtained prior to any study procedure being performed&#xD;
&#xD;
          -  Subject is a male or non-lactating female with a negative urine pregnancy test&#xD;
&#xD;
          -  Subject is aged 18 to 65 years, inclusive&#xD;
&#xD;
          -  Current diagnosis of opioid dependence or addiction per the Diagnostic and Statistical&#xD;
             Manual of Mental Disorders - 4th edition (text revision) (DSM-IV-TR) criteria&#xD;
             including physical dependence on opioids&#xD;
&#xD;
          -  Daily short-acting opiate use of at least 60 mg morphine equivalent no opioid use for&#xD;
             at least 12 hours prior to Screening with positive opiate result on urine drug screen&#xD;
&#xD;
          -  Clinical opioid withdrawal scale (COWS) score ≥9&#xD;
&#xD;
          -  Subject is in good general health in the judgment of the Investigator as determined&#xD;
             from the physical and oral examination findings.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of a long-acting opioid within the last 72 hours&#xD;
&#xD;
          -  Use of an investigational drug or device within the last 30 days&#xD;
&#xD;
          -  History of hypersensitivity, allergy, or intolerance to buprenorphine, naloxone, or&#xD;
             related drugs&#xD;
&#xD;
          -  Immediate suicidal risk, as determined by meeting any of the following:&#xD;
&#xD;
               1. History of suicidal ideation ≤ 3 months prior to Baseline with a score of 4&#xD;
                  (intent to act) or 5 (specific plan and intent) on the eC-SSRS&#xD;
&#xD;
               2. History of suicidal behavior ≤1 year prior to Baseline (actual attempt,&#xD;
                  interrupted attempt, aborted attempt and/or preparatory acts/behavior) on the&#xD;
                  eC-SSRS&#xD;
&#xD;
          -  A history or current evidence of any clinically significant disorder or any other&#xD;
             condition which in the opinion of the Investigator, would jeopardize the safety of the&#xD;
             subject or impact the validity of the study results&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>October 19, 2012</study_first_submitted>
  <study_first_submitted_qc>October 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 25, 2012</study_first_posted>
  <last_update_submitted>May 2, 2017</last_update_submitted>
  <last_update_submitted_qc>May 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Opioid-Related Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Buprenorphine</mesh_term>
    <mesh_term>Naloxone</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01713803
org study id: BNX-350
nct id: NCT01713803
lead sponsor: 
has dmc: No
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.
measure: The mean change in clinical opioid withdrawal scale (COWS) total score from Baseline to 6 hours following the initial dose
measure: The percentage of subjects with a negative result on the urine drug screen at Day 7
measure: The percentage of subjects with a clinical opioid withdrawal scale (COWS) total score ≤4 at 6 hours after the initial study drug dose
arm group label: Sugar pill
arm group type: Placebo Comparator
arm group label: buprenorphine and nalaxone
arm group type: Experimental
intervention type: Drug
intervention name: Buprenorphine and naloxone
arm group label: Sugar pill
arm group label: buprenorphine and nalaxone
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Opioid-Related Disorders
mesh term: Buprenorphine
mesh term: Naloxone