<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/NCT03809143</url>
  </required_header>
  <id_info>
    <org_study_id>CoLAB1801</org_study_id>
    <nct_id>NCT03809143</nct_id>
  </id_info>
  <brief_title>Community Studies of Long Acting Buprenorphine (CoLAB)</brief_title>
  <acronym>CoLAB</acronym>
  <official_title>An Open-label, Multicentre, Single-arm Trial of Monthly Injections of Depot Buprenorphine in People With Opioid Dependence</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of New South Wales</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of New South Wales</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Despite research demonstrating the efficacy of buprenorphine (BPN), effectiveness in&#xD;
      real-world settings has been limited by shorter retention than for methadone, and the need&#xD;
      for daily or near-daily dosing (frequently supervised in Australia). Newly developed&#xD;
      sustained-release BPN formulations could provide rapid onset and sustained release of BPN.&#xD;
&#xD;
      Current formulations include six-monthly implants, and once-weekly or once-monthly&#xD;
      injections, removing the need for frequent clinic or pharmacy attendance. Improved medication&#xD;
      adherence may result in improved patient outcomes and fewer unintended consequences such as&#xD;
      diversion, but more data are needed in real-world settings. These innovations have the&#xD;
      potential to dramatically change the treatment settings and options for people who are opioid&#xD;
      dependent.&#xD;
&#xD;
      The study aims to evaluate the patient outcomes following the implementation of a monthly BPN&#xD;
      depot injection for the treatment of opioid dependence in community-based treatment settings&#xD;
      with a focus on opioid and other illicit drug use, adherence and retention, and participants'&#xD;
      experiences of the implementation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Opioid agonist treatment (OAT) is effective for opioid dependence and newer extended-release&#xD;
      buprenorphine (BUP-XR) injections represent a significant development. The Community&#xD;
      Long-Acting Buprenorphine (CoLAB) study aims to evaluate client outcomes among people with&#xD;
      opioid dependence receiving 48 weeks of BUP-XR treatment, and examines the implementation of&#xD;
      BUP-XR in diverse community healthcare settings in Australia.&#xD;
&#xD;
      The CoLAB study is a prospective single-arm, multicentre, open-label trial of monthly BUP-XR&#xD;
      injections in people with opioid dependence. Participants are being recruited from a network&#xD;
      of general practitioner and specialist drug treatment services located in the states of New&#xD;
      South Wales, Victoria and South Australia in Australia. Following a minimum 7 days on 8-32mg&#xD;
      of sublingual buprenorphine (+/- naloxone), participants will receive monthly subcutaneous&#xD;
      BUP-XR injections administered by a healthcare practitioner at intervals of 28 days (-2/+14&#xD;
      days). The primary endpoint is participant retention in treatment at 48 weeks after treatment&#xD;
      initiation. Secondary endpoints will evaluate dosing schedule variations, craving,&#xD;
      withdrawal, substance use, health and well-being, and client-reported treatment experience.&#xD;
      Qualitative and costing sub-studies will examine implementation barriers and facilitators at&#xD;
      the client and provider level.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">May 22, 2019</start_date>
  <completion_date type="Anticipated">March 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">November 1, 2020</primary_completion_date>
  <phase>Phase 3</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Participant retention</measure>
    <time_frame>Retention in dosing schedule at 48 weeks</time_frame>
    <description>To examine treatment retention at 48 weeks following initiation of monthly depot RBP-6000 buprenorphine injections in patients with opioid dependence transferred from a stable dose of sublingual buprenorphine.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>BUP-XR treatment retention and engagement in ongoing clinical care</measure>
    <time_frame>48 weeks</time_frame>
    <description>To examine BUP-XR treatment retention and engagement in ongoing clinical care at 48 weeks ortion of participants retained in treatment at 48 weeks following initiation of monthly depot buprenorphine injections and engaged in ongoing clinical care. Treatment retention is defined as remaining on active depot buprenorphine medication AND completing a clinical assessment at 48 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in opioid withdrawal</measure>
    <time_frame>48 weeks</time_frame>
    <description>Change in opioid withdrawal assessed by clinical opioid withdrawal scale (COWS) and subjective opioid withdrawal scale (SOWS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in client-reported opioid craving</measure>
    <time_frame>48 weeks</time_frame>
    <description>Change in client-reported opioid craving assessed by opioid craving scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in client-reported drug use</measure>
    <time_frame>48 weeks</time_frame>
    <description>Change in client-reported use of opioids and other drugs, assessed by the Australian Treatment Outcomes Profile (ATOP) instrument</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BUP-XR dosing schedule adherence</measure>
    <time_frame>48 weeks</time_frame>
    <description>To evaluate client utilisation of buprenorphine medication during the study, including BUP-XR dose variation, adherence with dosing schedule, and dose supplementation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BUP-XR safety and tolerability</measure>
    <time_frame>48 weeks</time_frame>
    <description>To evaluate treatment safety and tolerability by monitoring adverse events, and events of clinical interest such as drug-drug interactions and pain management in clients treated with BUP-XR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in client-report pain and enjoyment</measure>
    <time_frame>48 weeks</time_frame>
    <description>To describe client-reported changes to pain and enjoyment of life, assessed by the Pain, Enjoyment, General Activity (PEG) scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Demographic factors associated with treatment retention</measure>
    <time_frame>48 weeks</time_frame>
    <description>To evaluate demographic factors (gender, age, education) associated with treatment retention, assessed by demographic questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Client treatment satisfaction score</measure>
    <time_frame>48 weeks</time_frame>
    <description>Client-reported treatment satisfaction assessed by the Treatment Questionnaire for Medication Satisfaction (TQSM)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BUP-XR treatment costs</measure>
    <time_frame>48 weeks</time_frame>
    <description>Costs to services delivering BUP-XR assessed by site-reported expenses and time and motion study</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Opioid Dependence</condition>
  <arm_group>
    <arm_group_label>Depot buprenorphine arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants will receive monthly injections of depot buprenorphine (RBP-6000, Sublocade)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>RBP-6000</intervention_name>
    <description>All study participants are scheduled to receive monthly subcutaneous injections of depot BPN, RBP-6000. RBP-6000 (BPN in the ATRIGEL® Delivery System) contains buprenorphine (200mg/mL) in the ATRIGEL® Delivery System, which provides sustained plasma level of BPN over a minimum of 28 days.</description>
    <arm_group_label>Depot buprenorphine arm</arm_group_label>
    <other_name>Sublocade</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        The study population is individuals diagnosed with opioid dependence who are currently&#xD;
        receiving sublingual buprenorphine treatment at participating drug and alcohol services,&#xD;
        express interest in receiving depot buprenorphine injections and are deemed suitable for&#xD;
        treatment with RBP-6000 by the Investigator.&#xD;
&#xD;
        Inclusion criteria&#xD;
&#xD;
        To be eligible for the study, participants must meet all of the following inclusion&#xD;
        criteria:&#xD;
&#xD;
          1. Voluntarily signed the informed consent form&#xD;
&#xD;
          2. Aged 18 to 65 years&#xD;
&#xD;
          3. Opioid-dependent (ICD-10) currently receiving treatment&#xD;
&#xD;
          4. Has been receiving 8-32mg sublingual buprenorphine +/- naloxone tablets/film for at&#xD;
             least 7 days&#xD;
&#xD;
          5. Negative pregnancy test at screening and baseline in females of childbearing potential&#xD;
             (please refer to Section 5.7 for long acting reversible contraceptive methods with&#xD;
             efficacy considered to reasonably eliminate pregnancy potential)&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
        Participants who meet any of the exclusion criteria are not to be enrolled in this study:&#xD;
&#xD;
          1. Currently lactating or pregnant, or of childbearing potential and not willing to avoid&#xD;
             becoming pregnant during the study&#xD;
&#xD;
          2. History or presence of allergic or adverse response (including rash or anaphylaxis) to&#xD;
             buprenorphine or the ATRIGEL® Delivery System&#xD;
&#xD;
          3. Significant, medical or psychiatric conditions (other than opioid dependence), or&#xD;
             other circumstances which, in the opinion of the Investigator, would compromise&#xD;
             compliance with the protocol and/or patient safety. Specific conditions of interest&#xD;
             include severe hepatic disease (Child-Pugh Class B), severe renal or respiratory&#xD;
             disease, or severe cognitive impairment or psychiatric condition that impairs the&#xD;
             ability to provide informed consent (e.g. psychosis, delirium, hypomania, severe&#xD;
             depression or suicidal ideation)&#xD;
&#xD;
          4. Subjects who are currently participating in any other clinical study involving&#xD;
             investigational medication(s)&#xD;
&#xD;
          5. Inability or unwillingness to provide informed consent or abide by the requirements of&#xD;
             the study&#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>Michael Farrell</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Drug and Alcohol Centre, University of New South Wales</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Drug and Alcohol Services, Hunter New England Local Health District</name>
      <address>
        <city>Newcastle</city>
        <state>New South Wales</state>
        <zip>2300</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Drug and Alcohol Services, North Sydney Local Health District</name>
      <address>
        <city>Saint Leonards</city>
        <state>New South Wales</state>
        <zip>2065</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Drug and Alcohol Services, South Australia (DASSA)</name>
      <address>
        <city>Morphett Vale</city>
        <state>South Australia</state>
        <zip>5162</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Western Health Drug Services, Footscray Hospital</name>
      <address>
        <city>Footscray</city>
        <state>Victoria</state>
        <zip>3011</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Frankston Healthcare</name>
      <address>
        <city>Frankston</city>
        <state>Victoria</state>
        <zip>3199</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rankin Court Treatment Centre, St Vincent's Hospital Sydney</name>
      <address>
        <city>Darlinghurst</city>
        <zip>2010</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>January 16, 2019</study_first_submitted>
  <study_first_submitted_qc>January 16, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>March 2, 2020</last_update_submitted>
  <last_update_submitted_qc>March 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of New South Wales</investigator_affiliation>
    <investigator_full_name>Marianne Byrne</investigator_full_name>
    <investigator_title>Clinical Trials Manager, National Drug and Alcohol Research Centre</investigator_title>
  </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>
  </intervention_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/NCT03809143
org study id: CoLAB1801
nct id: NCT03809143
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
Despite research demonstrating the efficacy of buprenorphine (BPN), effectiveness in
      real-world settings has been limited by shorter retention than for methadone, and the need
      for daily or near-daily dosing (frequently supervised in Australia). Newly developed
      sustained-release BPN formulations could provide rapid onset and sustained release of BPN.

      Current formulations include six-monthly implants, and once-weekly or once-monthly
      injections, removing the need for frequent clinic or pharmacy attendance. Improved medication
      adherence may result in improved patient outcomes and fewer unintended consequences such as
      diversion, but more data are needed in real-world settings. These innovations have the
      potential to dramatically change the treatment settings and options for people who are opioid
      dependent.

      The study aims to evaluate the patient outcomes following the implementation of a monthly BPN
      depot injection for the treatment of opioid dependence in community-based treatment settings
      with a focus on opioid and other illicit drug use, adherence and retention, and participants'
      experiences of the implementation.
Opioid agonist treatment (OAT) is effective for opioid dependence and newer extended-release
      buprenorphine (BUP-XR) injections represent a significant development. The Community
      Long-Acting Buprenorphine (CoLAB) study aims to evaluate client outcomes among people with
      opioid dependence receiving 48 weeks of BUP-XR treatment, and examines the implementation of
      BUP-XR in diverse community healthcare settings in Australia.

      The CoLAB study is a prospective single-arm, multicentre, open-label trial of monthly BUP-XR
      injections in people with opioid dependence. Participants are being recruited from a network
      of general practitioner and specialist drug treatment services located in the states of New
      South Wales, Victoria and South Australia in Australia. Following a minimum 7 days on 8-32mg
      of sublingual buprenorphine (+/- naloxone), participants will receive monthly subcutaneous
      BUP-XR injections administered by a healthcare practitioner at intervals of 28 days (-2/+14
      days). The primary endpoint is participant retention in treatment at 48 weeks after treatment
      initiation. Secondary endpoints will evaluate dosing schedule variations, craving,
      withdrawal, substance use, health and well-being, and client-reported treatment experience.
      Qualitative and costing sub-studies will examine implementation barriers and facilitators at
      the client and provider level.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Participant retention
time frame: Retention in dosing schedule at 48 weeks
description: To examine treatment retention at 48 weeks following initiation of monthly depot RBP-6000 buprenorphine injections in patients with opioid dependence transferred from a stable dose of sublingual buprenorphine.
measure: BUP-XR treatment retention and engagement in ongoing clinical care
time frame: 48 weeks
description: To examine BUP-XR treatment retention and engagement in ongoing clinical care at 48 weeks ortion of participants retained in treatment at 48 weeks following initiation of monthly depot buprenorphine injections and engaged in ongoing clinical care. Treatment retention is defined as remaining on active depot buprenorphine medication AND completing a clinical assessment at 48 weeks.
measure: Changes in opioid withdrawal
time frame: 48 weeks
description: Change in opioid withdrawal assessed by clinical opioid withdrawal scale (COWS) and subjective opioid withdrawal scale (SOWS)
measure: Changes in client-reported opioid craving
time frame: 48 weeks
description: Change in client-reported opioid craving assessed by opioid craving scale
measure: Changes in client-reported drug use
time frame: 48 weeks
description: Change in client-reported use of opioids and other drugs, assessed by the Australian Treatment Outcomes Profile (ATOP) instrument
measure: BUP-XR dosing schedule adherence
time frame: 48 weeks
description: To evaluate client utilisation of buprenorphine medication during the study, including BUP-XR dose variation, adherence with dosing schedule, and dose supplementation
measure: BUP-XR safety and tolerability
time frame: 48 weeks
description: To evaluate treatment safety and tolerability by monitoring adverse events, and events of clinical interest such as drug-drug interactions and pain management in clients treated with BUP-XR
measure: Changes in client-report pain and enjoyment
time frame: 48 weeks
description: To describe client-reported changes to pain and enjoyment of life, assessed by the Pain, Enjoyment, General Activity (PEG) scale
measure: Demographic factors associated with treatment retention
time frame: 48 weeks
description: To evaluate demographic factors (gender, age, education) associated with treatment retention, assessed by demographic questionnaire
measure: Client treatment satisfaction score
time frame: 48 weeks
description: Client-reported treatment satisfaction assessed by the Treatment Questionnaire for Medication Satisfaction (TQSM)
measure: BUP-XR treatment costs
time frame: 48 weeks
description: Costs to services delivering BUP-XR assessed by site-reported expenses and time and motion study
arm group label: Depot buprenorphine arm
arm group type: Experimental
description: All participants will receive monthly injections of depot buprenorphine (RBP-6000, Sublocade)
intervention type: Drug
intervention name: RBP-6000
description: All study participants are scheduled to receive monthly subcutaneous injections of depot BPN, RBP-6000. RBP-6000 (BPN in the ATRIGEL® Delivery System) contains buprenorphine (200mg/mL) in the ATRIGEL® Delivery System, which provides sustained plasma level of BPN over a minimum of 28 days.
arm group label: Depot buprenorphine arm
other name: Sublocade
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Michael Farrell
role: Principal Investigator
affiliation: National Drug and Alcohol Centre, University of New South Wales
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Australia
responsible party type: Principal Investigator
investigator affiliation: The University of New South Wales
investigator full name: Marianne Byrne
investigator title: Clinical Trials Manager, National Drug and Alcohol Research Centre
mesh term: Opioid-Related Disorders
mesh term: Buprenorphine
sharing ipd: No