<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/NCT03838510</url>
  </required_header>
  <id_info>
    <org_study_id>5R01DA045690-02</org_study_id>
    <nct_id>NCT03838510</nct_id>
  </id_info>
  <brief_title>Repeated-dose Behavioral Intervention to Reduce Opioid Overdose</brief_title>
  <acronym>REBOOT</acronym>
  <official_title>Repeated-dose Behavioral Intervention to Reduce Opioid Overdose: A Two-Site Randomized-Controlled Efficacy Trial (REBOOT)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>San Francisco Department of Public Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>San Francisco Department of Public Health</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      REBOOT is a randomized trial of a repeated-dose brief intervention to reduce overdose and&#xD;
      risk behaviors among naloxone recipients with opioid use disorder. It includes an established&#xD;
      overdose education curriculum within an Informational-Motivation-Behavior (IMB) model. This&#xD;
      study will test the efficacy of REBOOT vs attention-control.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">April 22, 2019</start_date>
  <completion_date type="Anticipated">September 2023</completion_date>
  <primary_completion_date type="Anticipated">September 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Occurrence of overdose events</measure>
    <time_frame>16 Months</time_frame>
    <description>Occurrence of overdose events will be measured by self-report via timeline follow-back (TLFB) assessment, ED/EMS records, and Vital records.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of overdose events</measure>
    <time_frame>16 Months</time_frame>
    <description>Number of overdose events will be measured by self-report via timeline follow-back (TLFB) assessment, ED/EMS records, and Vital records.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Days of substance use treatment</measure>
    <time_frame>16 Months</time_frame>
    <description>Days of substance use treatment will be measured by self-report via TLFB and with appropriate HIPAA/CFR-42 release.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dates of substance use treatment</measure>
    <time_frame>16 Months</time_frame>
    <description>Dates of substance use treatment will be measured by self-report via TLFB and with appropriate HIPAA/CFR-42 release.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Modality of substance use treatment</measure>
    <time_frame>16 Months</time_frame>
    <description>Substance use treatment modality will be measured by self-report via TLFB and with appropriate HIPAA/CFR-42 release.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of days of opioid use</measure>
    <time_frame>16 Months</time_frame>
    <description>Days of substance use treatment will be measured by self-report via TLFB.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">268</enrollment>
  <condition>Opioid-Related Disorders</condition>
  <condition>Drug Overdose</condition>
  <arm_group>
    <arm_group_label>Brief Counseling Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>REBOOT</intervention_name>
    <description>The brief counseling intervention will utilize Motivational Interviewing and skills-building techniques to modify personal overdose risk behaviors and develop skills as a peer responder for witnessed overdose. The counselor will draw upon themes of safer substance use to address overdose risk behaviors and determine readiness for change in substance use.</description>
    <arm_group_label>Brief Counseling Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18-65 years&#xD;
&#xD;
          -  Characteristics of opioid use history&#xD;
&#xD;
          -  Previously received take-home naloxone&#xD;
&#xD;
          -  No life-threatening illness likely to progress clinically during trial&#xD;
&#xD;
          -  Able/willing to provide informed consent and locator information, communicate in&#xD;
             English, and adhere to visit schedule&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Suicidal ideation&#xD;
&#xD;
          -  Participating in another interventional study that could possibly impact the study's&#xD;
             outcomes of interest&#xD;
&#xD;
          -  Planning to leave San Francisco/Boston metro area during study&#xD;
&#xD;
          -  Previously exposed to REBOOT counseling intervention&#xD;
&#xD;
          -  Any condition that, in the Principal Investigator's judgment, interferes with safe&#xD;
             study participation or adherence to study procedures&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Phillip O Coffin, MD, MIA</last_name>
    <role>Principal Investigator</role>
    <affiliation>San Francisco Department of Public Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>San Francisco Department of Public Health</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boston Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>February 7, 2019</study_first_submitted>
  <study_first_submitted_qc>February 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>April 4, 2023</last_update_submitted>
  <last_update_submitted_qc>April 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>San Francisco Department of Public Health</investigator_affiliation>
    <investigator_full_name>Phillip Coffin, MD, MIA</investigator_full_name>
    <investigator_title>Director, Substance Use Research Unit</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Drug Overdose</mesh_term>
    <mesh_term>Opioid-Related Disorders</mesh_term>
    <mesh_term>Opiate Overdose</mesh_term>
  </condition_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/NCT03838510
org study id: 5R01DA045690-02
nct id: NCT03838510
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
REBOOT is a randomized trial of a repeated-dose brief intervention to reduce overdose and
      risk behaviors among naloxone recipients with opioid use disorder. It includes an established
      overdose education curriculum within an Informational-Motivation-Behavior (IMB) model. This
      study will test the efficacy of REBOOT vs attention-control.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Occurrence of overdose events
time frame: 16 Months
description: Occurrence of overdose events will be measured by self-report via timeline follow-back (TLFB) assessment, ED/EMS records, and Vital records.
measure: Number of overdose events
time frame: 16 Months
description: Number of overdose events will be measured by self-report via timeline follow-back (TLFB) assessment, ED/EMS records, and Vital records.
measure: Days of substance use treatment
time frame: 16 Months
description: Days of substance use treatment will be measured by self-report via TLFB and with appropriate HIPAA/CFR-42 release.
measure: Dates of substance use treatment
time frame: 16 Months
description: Dates of substance use treatment will be measured by self-report via TLFB and with appropriate HIPAA/CFR-42 release.
measure: Modality of substance use treatment
time frame: 16 Months
description: Substance use treatment modality will be measured by self-report via TLFB and with appropriate HIPAA/CFR-42 release.
measure: Number of days of opioid use
time frame: 16 Months
description: Days of substance use treatment will be measured by self-report via TLFB.
arm group label: Brief Counseling Intervention
arm group type: Experimental
arm group label: Control Group
arm group type: No Intervention
intervention type: Behavioral
intervention name: REBOOT
description: The brief counseling intervention will utilize Motivational Interviewing and skills-building techniques to modify personal overdose risk behaviors and develop skills as a peer responder for witnessed overdose. The counselor will draw upon themes of safer substance use to address overdose risk behaviors and determine readiness for change in substance use.
arm group label: Brief Counseling Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Phillip O Coffin, MD, MIA
role: Principal Investigator
affiliation: San Francisco Department of Public Health
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: San Francisco Department of Public Health
investigator full name: Phillip Coffin, MD, MIA
investigator title: Director, Substance Use Research Unit
mesh term: Drug Overdose
mesh term: Opioid-Related Disorders
mesh term: Opiate Overdose