<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/NCT01717963</url>
  </required_header>
  <id_info>
    <org_study_id>2011-002858-31</org_study_id>
    <secondary_id>204725-1</secondary_id>
    <nct_id>NCT01717963</nct_id>
  </id_info>
  <brief_title>Naltrexone vs Buprenorphine-Naloxone for Opioid Dependence in Norway</brief_title>
  <acronym>NTX-SBX</acronym>
  <official_title>Optimal Prevention of Overdose Deaths and Opioid Relapse Following Discharge: A Multi-Center RCT of Naltrexone Versus Buprenorphine in Norway</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Oslo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Research Council of Norway</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Royal Norwegian Ministry of Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Norwegian Institute of Public Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Oslo University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital, Akershus</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Haukeland University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Helse Stavanger HF</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Hospital of Vestfold</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ostfold Hospital Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Oslo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Persons dependent on opioids like heroin, morphine, or codeine have a high risk of relapse,&#xD;
      overdose and overdose death. This risk is elevated even further following discharge from&#xD;
      treatment or correctional institutions where patients have been detoxified. At the moment,&#xD;
      state-of-the-art treatment is based on maintaining the dependence on opioids by daily intake&#xD;
      of opioid medications like methadone or buprenorphine. Recently, a medication containing the&#xD;
      blocking agent naltrexone was approved in the US; this does not maintain dependence but&#xD;
      instead blocks heroin and other opioids for 28 days after intramuscular administration. This&#xD;
      study will conduct a 12-week randomized comparison of naltrexone intramuscular suspension&#xD;
      (XL-NTX) with daily buprenorphine-naloxone in OMT. Medication will start preceding discharge&#xD;
      from a treatment or correctional facility to participating catchment regions in Norway. The&#xD;
      main hypotheses are that XL-NTX will do equally well as - or better than - OMT on the&#xD;
      proportion of biological samples negative for opioids, retention, self-reported use of&#xD;
      alcohol and illicit drugs. Following the 12-week randomized period, there will be a 36-week&#xD;
      period where participants can receive the study medication of their choice. After the end of&#xD;
      the study, data from national registry databases can be collected for a further 12 months on&#xD;
      outcomes such as recidivism, mortality and morbidity.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">April 30, 2018</completion_date>
  <primary_completion_date type="Actual">August 31, 2016</primary_completion_date>
  <phase>Phase 3</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of biological samples negative/positive for opioid agonists</measure>
    <time_frame>Week 1-12 post discharge</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Retention</measure>
    <time_frame>Week 1-12 post discharge</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Days of use or abstinence from opioids</measure>
    <time_frame>Week 1-12 post discharge</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Use of other substances of abuse</measure>
    <time_frame>Week 1-48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mental health</measure>
    <time_frame>Week 1-12 or 1-48</time_frame>
    <description>Self-reported mental health</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Somatic health</measure>
    <time_frame>Week 1-12 or 1-48 post discharge</time_frame>
    <description>Self-reported and/or assessed by study personnel</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychosocial problems</measure>
    <time_frame>Week 1-12, Week 1-48, &amp; Wk 49-100</time_frame>
    <description>Psychosocial problems like recidivism, employment, family problems. Self-reported or registry-based.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">166</enrollment>
  <condition>Opioid Dependence</condition>
  <arm_group>
    <arm_group_label>Naltrexone intramuscular suspension</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Extended release naltrexone injections 380mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Buprenorphine-naloxone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Flexible oral dose 4-24 mg daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Naltrexone intramuscular suspension</intervention_name>
    <description>A standard dosage of 380 mg / month of naltrexone intramuscular suspension will be administered</description>
    <arm_group_label>Naltrexone intramuscular suspension</arm_group_label>
    <other_name>Long-acting naltrexone</other_name>
    <other_name>Extended-release naltrexone</other_name>
    <other_name>XR-NTX</other_name>
    <other_name>Vivitrol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Buprenorphine-naloxone</intervention_name>
    <description>Buprenorphine-naloxone is administered daily and provided in accordance with existing guidelines for OMT in Norway (treatment-as-usual).</description>
    <arm_group_label>Buprenorphine-naloxone</arm_group_label>
    <other_name>Suboxone</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Opioid dependence (DSM-IV TR)&#xD;
&#xD;
          -  Age 18 or above&#xD;
&#xD;
          -  Applied &amp; Approved for Norway's national OMT program&#xD;
&#xD;
          -  Discharge within 30 days of inclusion from a controlled environment; e.g. inpatient&#xD;
             treatment or correctional (prison) facility&#xD;
&#xD;
          -  Voluntarily seeking treatment for opioid dependence&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or breast-feeding&#xD;
&#xD;
          -  Acute or recurring severe psychiatric disorder, e.g. psychosis, suicidality&#xD;
&#xD;
          -  Serious debilitation of liver or renal function (e.g. Child-Pugh level C)&#xD;
&#xD;
          -  Use of excluded medication&#xD;
&#xD;
          -  Known intolerance to study drugs or their ingredients&#xD;
&#xD;
          -  Employment in firm manufacturing one of the study drugs or close relation to such&#xD;
             person&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lars Tanum, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Oslo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Akershus University Hospital</name>
      <address>
        <city>Oslo</city>
        <state>Akershus</state>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Haukeland University Hospital</name>
      <address>
        <city>Bergen</city>
        <state>Hordaland</state>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stavanger University Hospital</name>
      <address>
        <city>Stavanger</city>
        <state>Rogaland</state>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vestfold Hospital Trust</name>
      <address>
        <city>Tonsberg</city>
        <state>Vestfold</state>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oslo University Hospital, Avdeling for Rus og Avhengighet</name>
      <address>
        <city>Oslo</city>
        <zip>0407</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <link>
    <url>http://naltrekson.no</url>
    <description>Website for the Univ of Oslo Naltrexone study group (in Norwegian)</description>
  </link>
  <link>
    <url>http://www.seraf.uio.no/</url>
    <description>Webpage of the study Sponsor: The Norwegian Centre for Addiction Research, Univ of Oslo</description>
  </link>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>October 28, 2012</study_first_submitted>
  <study_first_submitted_qc>October 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 31, 2012</study_first_posted>
  <last_update_submitted>October 10, 2018</last_update_submitted>
  <last_update_submitted_qc>October 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Oslo</investigator_affiliation>
    <investigator_full_name>Lars Tanum</investigator_full_name>
    <investigator_title>National Coordinating Investigator (PI)</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>Naltrexone</mesh_term>
    <mesh_term>Buprenorphine</mesh_term>
    <mesh_term>Buprenorphine, Naloxone Drug Combination</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/NCT01717963
org study id: 2011-002858-31
secondary id: 204725-1
nct id: NCT01717963
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
Persons dependent on opioids like heroin, morphine, or codeine have a high risk of relapse,
      overdose and overdose death. This risk is elevated even further following discharge from
      treatment or correctional institutions where patients have been detoxified. At the moment,
      state-of-the-art treatment is based on maintaining the dependence on opioids by daily intake
      of opioid medications like methadone or buprenorphine. Recently, a medication containing the
      blocking agent naltrexone was approved in the US; this does not maintain dependence but
      instead blocks heroin and other opioids for 28 days after intramuscular administration. This
      study will conduct a 12-week randomized comparison of naltrexone intramuscular suspension
      (XL-NTX) with daily buprenorphine-naloxone in OMT. Medication will start preceding discharge
      from a treatment or correctional facility to participating catchment regions in Norway. The
      main hypotheses are that XL-NTX will do equally well as - or better than - OMT on the
      proportion of biological samples negative for opioids, retention, self-reported use of
      alcohol and illicit drugs. Following the 12-week randomized period, there will be a 36-week
      period where participants can receive the study medication of their choice. After the end of
      the study, data from national registry databases can be collected for a further 12 months on
      outcomes such as recidivism, mortality and morbidity.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of biological samples negative/positive for opioid agonists
time frame: Week 1-12 post discharge
measure: Retention
time frame: Week 1-12 post discharge
measure: Days of use or abstinence from opioids
time frame: Week 1-12 post discharge
measure: Use of other substances of abuse
time frame: Week 1-48
measure: Mental health
time frame: Week 1-12 or 1-48
description: Self-reported mental health
measure: Somatic health
time frame: Week 1-12 or 1-48 post discharge
description: Self-reported and/or assessed by study personnel
measure: Psychosocial problems
time frame: Week 1-12, Week 1-48, & Wk 49-100
description: Psychosocial problems like recidivism, employment, family problems. Self-reported or registry-based.
arm group label: Naltrexone intramuscular suspension
arm group type: Experimental
description: Extended release naltrexone injections 380mg
arm group label: Buprenorphine-naloxone
arm group type: Active Comparator
description: Flexible oral dose 4-24 mg daily
intervention type: Drug
intervention name: Naltrexone intramuscular suspension
description: A standard dosage of 380 mg / month of naltrexone intramuscular suspension will be administered
arm group label: Naltrexone intramuscular suspension
other name: Long-acting naltrexone
other name: Extended-release naltrexone
other name: XR-NTX
other name: Vivitrol
intervention type: Drug
intervention name: Buprenorphine-naloxone
description: Buprenorphine-naloxone is administered daily and provided in accordance with existing guidelines for OMT in Norway (treatment-as-usual).
arm group label: Buprenorphine-naloxone
other name: Suboxone
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lars Tanum, MD, PhD
role: Principal Investigator
affiliation: University of Oslo
facility: 
facility: 
facility: 
facility: 
facility: 
country: Norway
url: http://naltrekson.no
description: Website for the Univ of Oslo Naltrexone study group (in Norwegian)
url: http://www.seraf.uio.no/
description: Webpage of the study Sponsor: The Norwegian Centre for Addiction Research, Univ of Oslo
responsible party type: Principal Investigator
investigator affiliation: University of Oslo
investigator full name: Lars Tanum
investigator title: National Coordinating Investigator (PI)
mesh term: Opioid-Related Disorders
mesh term: Naltrexone
mesh term: Buprenorphine
mesh term: Buprenorphine, Naloxone Drug Combination
mesh term: Naloxone