<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/NCT04505540</url>
  </required_header>
  <id_info>
    <org_study_id>CHRMS: 18-0695</org_study_id>
    <secondary_id>1R21DA049859-01</secondary_id>
    <nct_id>NCT04505540</nct_id>
  </id_info>
  <brief_title>Start Treatment and Recovery for Opioid Use Disorder</brief_title>
  <acronym>STAR</acronym>
  <official_title>Effectiveness of Bridge Clinic Following Emergency Department-Initiated Intervention for Opioid Use Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Vermont</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Substance Abuse and Mental Health Services Administration (SAMHSA)</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute on Drug Abuse (NIDA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Vermont</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is 1) to evaluate whether emergency department-initiated medically&#xD;
      assisted treatment with Buprenorphine/Naloxone in patients presenting with opioid use&#xD;
      disorder will produce positive outcomes at 1 week, 3 months and 6 months after treatment&#xD;
      initiation, and 2) to determine whether emergency department referrals to a bridge clinic&#xD;
      improve outcomes relative to direct referrals to a local waivered physician.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The emergency department is a critical missed opportunity to engage patients with opioid use&#xD;
      disorder in medication-assisted treatment, the most effective current treatment for the&#xD;
      disorder. Patients presenting at the emergency department with opioid use disorder will be&#xD;
      given the opportunity to immediately start medication assisted treatment with&#xD;
      Naloxone/Buprenorphine then referred either to a specialized addiction bridge clinic or a&#xD;
      local waivered provider for further treatment. Differences in outcomes related to whether the&#xD;
      patient is referred to a bridge clinic or local provider will be assessed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 30, 2019</start_date>
  <completion_date type="Actual">October 31, 2022</completion_date>
  <primary_completion_date type="Actual">October 31, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Self-report treatment retention</measure>
    <time_frame>1 week</time_frame>
    <description>Enrollment in treatment for opioid use disorder after 1 week</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Self-report treatment retention</measure>
    <time_frame>3 momths</time_frame>
    <description>Enrollment in treatment for opioid use disorder after 3 months</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Self report treatment retention</measure>
    <time_frame>6 months</time_frame>
    <description>Enrollment in treatment for opioid use disorder after 6 months</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Urinalysis for illicit opioid use</measure>
    <time_frame>1 week</time_frame>
    <description>Urine analyzed for opioids (buprenorphine, methadone, oxycodone, hydrocodone, hydromorphone, heroin, fentanyl) and other drugs (cocaine, amphetamines, benzodiazepines, cannabinoids) via enzyme multiplied immunoassay.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urinalysis for illicit opioid use</measure>
    <time_frame>3 months</time_frame>
    <description>Urine analyzed for opioids (buprenorphine, methadone, oxycodone, hydrocodone, hydromorphone, heroin, fentanyl) and other drugs (cocaine, amphetamines, benzodiazepines, cannabinoids) via enzyme multiplied immunoassay.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urinalysis for illicit opioid use</measure>
    <time_frame>6 months</time_frame>
    <description>Urine analyzed for opioids (buprenorphine, methadone, oxycodone, hydrocodone, hydromorphone, heroin, fentanyl) and other drugs (cocaine, amphetamines, benzodiazepines, cannabinoids) via enzyme multiplied immunoassay.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">104</enrollment>
  <condition>Opioid-use Disorder</condition>
  <condition>Mental Disorder</condition>
  <condition>Opioid Medication Assisted Treatment</condition>
  <arm_group>
    <arm_group_label>Bridge Clinic</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Medication assisted treatment supervised by addiction bridge clinic until stabilized in treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Local Waivered Physcian</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Medication assisted treatment supervised by local waivered physician.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Bridge Clinic</intervention_name>
    <description>Specialized addiction bridge clinic</description>
    <arm_group_label>Bridge Clinic</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Local Waivered Physician</intervention_name>
    <description>Direct referral to local waivered physician</description>
    <arm_group_label>Local Waivered Physcian</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient at Emergency Department&#xD;
&#xD;
          -  Diagnosis opioid use disorder according to criteria Diagnostic and Statistical Manual&#xD;
             (DSM) 5&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participating in alternate treatment program for opioid use disorder&#xD;
&#xD;
          -  Prisoner&#xD;
&#xD;
          -  Inability to communicate&#xD;
&#xD;
          -  Psychosis&#xD;
&#xD;
          -  Suicidality&#xD;
&#xD;
          -  History of Buprenorphine injection&#xD;
&#xD;
          -  Critical Illness&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Champlain Valley Physician's Hospital</name>
      <address>
        <city>Plattsburgh</city>
        <state>New York</state>
        <zip>12901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Vermont Medical Center</name>
      <address>
        <city>Burlington</city>
        <state>Vermont</state>
        <zip>05401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>January 3, 2023</last_update_submitted>
  <last_update_submitted_qc>January 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 4, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Vermont</investigator_affiliation>
    <investigator_full_name>Scott Mackey</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Opioid-Related Disorders</mesh_term>
    <mesh_term>Substance-Related Disorders</mesh_term>
    <mesh_term>Mental 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/NCT04505540
org study id: CHRMS: 18-0695
secondary id: 1R21DA049859-01
nct id: NCT04505540
lead sponsor: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is 1) to evaluate whether emergency department-initiated medically
      assisted treatment with Buprenorphine/Naloxone in patients presenting with opioid use
      disorder will produce positive outcomes at 1 week, 3 months and 6 months after treatment
      initiation, and 2) to determine whether emergency department referrals to a bridge clinic
      improve outcomes relative to direct referrals to a local waivered physician.
The emergency department is a critical missed opportunity to engage patients with opioid use
      disorder in medication-assisted treatment, the most effective current treatment for the
      disorder. Patients presenting at the emergency department with opioid use disorder will be
      given the opportunity to immediately start medication assisted treatment with
      Naloxone/Buprenorphine then referred either to a specialized addiction bridge clinic or a
      local waivered provider for further treatment. Differences in outcomes related to whether the
      patient is referred to a bridge clinic or local provider will be assessed.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Self-report treatment retention
time frame: 1 week
description: Enrollment in treatment for opioid use disorder after 1 week
measure: Self-report treatment retention
time frame: 3 momths
description: Enrollment in treatment for opioid use disorder after 3 months
measure: Self report treatment retention
time frame: 6 months
description: Enrollment in treatment for opioid use disorder after 6 months
measure: Urinalysis for illicit opioid use
time frame: 1 week
description: Urine analyzed for opioids (buprenorphine, methadone, oxycodone, hydrocodone, hydromorphone, heroin, fentanyl) and other drugs (cocaine, amphetamines, benzodiazepines, cannabinoids) via enzyme multiplied immunoassay.
measure: Urinalysis for illicit opioid use
time frame: 3 months
description: Urine analyzed for opioids (buprenorphine, methadone, oxycodone, hydrocodone, hydromorphone, heroin, fentanyl) and other drugs (cocaine, amphetamines, benzodiazepines, cannabinoids) via enzyme multiplied immunoassay.
measure: Urinalysis for illicit opioid use
time frame: 6 months
description: Urine analyzed for opioids (buprenorphine, methadone, oxycodone, hydrocodone, hydromorphone, heroin, fentanyl) and other drugs (cocaine, amphetamines, benzodiazepines, cannabinoids) via enzyme multiplied immunoassay.
arm group label: Bridge Clinic
arm group type: Active Comparator
description: Medication assisted treatment supervised by addiction bridge clinic until stabilized in treatment.
arm group label: Local Waivered Physcian
arm group type: Active Comparator
description: Medication assisted treatment supervised by local waivered physician.
intervention type: Other
intervention name: Bridge Clinic
description: Specialized addiction bridge clinic
arm group label: Bridge Clinic
intervention type: Other
intervention name: Local Waivered Physician
description: Direct referral to local waivered physician
arm group label: Local Waivered Physcian
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Vermont
investigator full name: Scott Mackey
investigator title: Assistant Professor
mesh term: Opioid-Related Disorders
mesh term: Substance-Related Disorders
mesh term: Mental Disorders
sharing ipd: No