<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/NCT03762798</url>
  </required_header>
  <id_info>
    <org_study_id>18-863</org_study_id>
    <nct_id>NCT03762798</nct_id>
  </id_info>
  <brief_title>Can The Bridge Transition Opiate Use Disorder Patients in Stable Recovery From Buprenorphine to Naltrexone</brief_title>
  <official_title>Can The Bridge Facilitate Successful Transition From Medication-Assisted Treatment (MAT) With Low-dose Sublingual Buprenorphine to Oral Naltrexone in Patients With Extended Remission of Opiate Use Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Cleveland Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Cleveland Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an open-label, single center study of The Bridge in patients with sustained remission&#xD;
      of opiate dependence on established, low-dose MAT with buprenorphine. A fixed number of&#xD;
      patients will be admitted to the study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open-label, single center study of The Bridge in patients with sustained remission&#xD;
      of opiate dependence on established, low-dose MAT with buprenorphine. A fixed number of&#xD;
      patients will be admitted to the study.&#xD;
&#xD;
      After determination that the subject meets the inclusion criteria and does not meet any of&#xD;
      the exclusion criteria for the study, the subject will receive the device which will be&#xD;
      applied in the clinical office setting on an outpatient basis. Buprenorphine MAT will be&#xD;
      stopped immediately and the subject will be followed on an outpatient basis to ensure the&#xD;
      process has been successful. The subject will have the option to return to the office for a&#xD;
      follow-up assessment in 1-4 days after device application. Seven to ten days after the last&#xD;
      dose of buprenorphine, a urine sample will be collected for drug testing and a prescription&#xD;
      for naltrexone will be provided. Then three visits on a roughly monthly basis will be&#xD;
      scheduled. At each visit a urine sample for drug testing will be collected. After three&#xD;
      follow-up visits are completed, if the drug testing demonstrates continued sobriety, the&#xD;
      subject will be released from the study and may or may not continue treatment with&#xD;
      naltrexone.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Not able to enroll participants.&#xD;
  </why_stopped>
  <start_date type="Actual">November 19, 2018</start_date>
  <completion_date type="Actual">December 1, 2020</completion_date>
  <primary_completion_date type="Actual">October 25, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Primary Objective</measure>
    <time_frame>Three Months</time_frame>
    <description>Number of patients who complete three follow-up visits while taking naltrexone and produce entirely negative urine opiate screens during that period</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Substance Use Disorders</condition>
  <condition>Substance Abuse</condition>
  <condition>Substance Use</condition>
  <condition>Substance Dependence</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants will receive the Bridge device.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>The Bridge</intervention_name>
    <description>The Bridge (Also known as NSS-2) is a percutaneous, auricular field stimulator developed to alleviate pain through stimulation of peripheral cranial neurovascular bundles in the external ear that could potentially gain access to brain areas involved in fear, pain and nociception. After five days, the subject will return to the clinic for device removal and disposal.</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of opiate use disorder, any severity&#xD;
&#xD;
          -  Age range 18-99 years old&#xD;
&#xD;
          -  Not pregnant or breastfeeding&#xD;
&#xD;
          -  Able to understand and provide informed consent.&#xD;
&#xD;
          -  Able to understand and speak the English language.&#xD;
&#xD;
          -  At least one year of abstinence from drugs of abuse including, but not limited to, all&#xD;
             opiates, cannabis, benzodiazepines, barbiturates, alcohol and cocaine.&#xD;
&#xD;
          -  Use of nicotine is excluded from this criterion.&#xD;
&#xD;
          -  Use of any prescribed, controlled substance, taken according to the prescribing&#xD;
             instructions, for no more than seven consecutive days, at least three months prior to&#xD;
             the subject's study enrollment, is excluded from this criterion.&#xD;
&#xD;
          -  Taking dose of buprenorphine less than or equal to no more than 4 mg daily for at&#xD;
             least three months prior to starting the study.&#xD;
&#xD;
          -  In the case of Zubsolv rapid-dissolve tablets, equivalent daily dose maximum would be&#xD;
             2.9mg.&#xD;
&#xD;
          -  In the case of Bunavail buccal film, equivalent daily dose maximum would be 2.1mg.&#xD;
&#xD;
          -  At least one year of self-reported, established 12-step based recovery work, including&#xD;
&#xD;
          -  Home group membership and regular attendance of two 12- step meetings per week&#xD;
&#xD;
          -  Regular work with 12-step sponsor who can attest that the subject has worked through&#xD;
             step nine of the twelve steps of Alcoholics Anonymous or a similar 12-step based&#xD;
             mutual help organization.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exhibits active psychosis or suicide ideation or is otherwise psychiatrically&#xD;
             unstable.&#xD;
&#xD;
          -  Positive Utox2 Immunoassay, Quantitative Pain Panel Liquid Chromatography/Mass&#xD;
             Spectroscopy, or Ethylglucuronide test for any nonprescribed substance or medication.&#xD;
&#xD;
          -  Meets criteria for any other active substance use disorder except nicotine&#xD;
&#xD;
          -  Allergic to naltrexone or has any condition of such nature and/or severity that would&#xD;
             clinically contraindicate the prescribing of naltrexone.&#xD;
&#xD;
          -  Any condition that contraindicates the use of NSS-2 including hemophilia, cardiac&#xD;
             pacemakers and psoriasis vulgaris.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David W Streem, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Cleveland Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cleveland Clinic Lutheran Hospital</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44113</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>November 28, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>September 17, 2021</last_update_submitted>
  <last_update_submitted_qc>September 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Cleveland Clinic</investigator_affiliation>
    <investigator_full_name>David Streem, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>substance abuse</keyword>
  <keyword>the bridge</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Substance-Related Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03762798
org study id: 18-863
nct id: NCT03762798
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
This is an open-label, single center study of The Bridge in patients with sustained remission
      of opiate dependence on established, low-dose MAT with buprenorphine. A fixed number of
      patients will be admitted to the study.
This is an open-label, single center study of The Bridge in patients with sustained remission
      of opiate dependence on established, low-dose MAT with buprenorphine. A fixed number of
      patients will be admitted to the study.

      After determination that the subject meets the inclusion criteria and does not meet any of
      the exclusion criteria for the study, the subject will receive the device which will be
      applied in the clinical office setting on an outpatient basis. Buprenorphine MAT will be
      stopped immediately and the subject will be followed on an outpatient basis to ensure the
      process has been successful. The subject will have the option to return to the office for a
      follow-up assessment in 1-4 days after device application. Seven to ten days after the last
      dose of buprenorphine, a urine sample will be collected for drug testing and a prescription
      for naltrexone will be provided. Then three visits on a roughly monthly basis will be
      scheduled. At each visit a urine sample for drug testing will be collected. After three
      follow-up visits are completed, if the drug testing demonstrates continued sobriety, the
      subject will be released from the study and may or may not continue treatment with
      naltrexone.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Primary Objective
time frame: Three Months
description: Number of patients who complete three follow-up visits while taking naltrexone and produce entirely negative urine opiate screens during that period
arm group label: Treatment
arm group type: Experimental
description: All participants will receive the Bridge device.
intervention type: Device
intervention name: The Bridge
description: The Bridge (Also known as NSS-2) is a percutaneous, auricular field stimulator developed to alleviate pain through stimulation of peripheral cranial neurovascular bundles in the external ear that could potentially gain access to brain areas involved in fear, pain and nociception. After five days, the subject will return to the clinic for device removal and disposal.
arm group label: Treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: David W Streem, MD
role: Principal Investigator
affiliation: The Cleveland Clinic
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: The Cleveland Clinic
investigator full name: David Streem, MD
investigator title: Principal Investigator
mesh term: Substance-Related Disorders
sharing ipd: No