<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/NCT02195817</url>
  </required_header>
  <id_info>
    <org_study_id>15892A</org_study_id>
    <secondary_id>2013-004688-30</secondary_id>
    <nct_id>NCT02195817</nct_id>
  </id_info>
  <brief_title>Study of 18 mg Selincro® As-needed Use, in the Treatment of Patients With Alcohol Dependence in Primary Care</brief_title>
  <official_title>Interventional, Open-label Study of 18 mg Selincro® As-needed Use, in the Treatment of Patients With Alcohol Dependence in Primary Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>H. Lundbeck A/S</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>H. Lundbeck A/S</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To determine the reduction in alcohol consumption in patients with alcohol dependence treated&#xD;
      with 18 mg Selincro® as-needed use, in conjunction with continuous psychosocial support in&#xD;
      primary care&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      635 patients are planned (total number of patients) with 475 patients treated with Selincro®&#xD;
      (Cohort A) and 160 patients not treated with Selincro® (Cohort B) to determine the reduction&#xD;
      in alcohol consumption in patients with alcohol dependence.&#xD;
&#xD;
      Cohort A will comprise patients who maintain a high drinking risk level (DRL, defined by&#xD;
      World Health Organization (WHO) as &gt;60g alcohol/day for a man or &gt;40g alcohol/day for a&#xD;
      woman), or above, in the period between the Screening and Inclusion Visits.&#xD;
&#xD;
      Cohort B will comprise patients who reduce their alcohol consumption in the period between&#xD;
      the Screening and Inclusion visits, that is, patients who do not maintain at least a high DRL&#xD;
      at the Inclusion Visit (and are therefore not eligible for treatment with nalmefene according&#xD;
      to the SmPC).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The study was terminated due to enrolment challenges&#xD;
  </why_stopped>
  <start_date type="Actual">August 2014</start_date>
  <completion_date type="Actual">February 2016</completion_date>
  <primary_completion_date type="Actual">February 2016</primary_completion_date>
  <phase>Phase 4</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in the number of Heavy Drinking Days (HDDs) (days/month)</measure>
    <time_frame>Baseline to Month 3</time_frame>
    <description>Cohort A</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Total Alcohol Consumption (TAC) (g/day)</measure>
    <time_frame>Baseline to Month 3</time_frame>
    <description>Cohort A</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Drinking Risk Level response (RSDRL); defined as a downward shift in Drinking Risk Level (DRL); for patients with a very high DRL at baseline, a shift to medium DRL or below; for patients with a high DRL at baseline, a shift to low DRL or below</measure>
    <time_frame>Baseline to Month 3</time_frame>
    <description>Cohort A</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>RLDRL response; defined as a downward shift in DRL to low DRL or below</measure>
    <time_frame>Baseline to Month 3</time_frame>
    <description>Cohort A</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response defined as ≥70% reduction in TAC</measure>
    <time_frame>Baseline to Month 3</time_frame>
    <description>Cohort A</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response defined as 0 to 4 HDDs (days/month)</measure>
    <time_frame>Month 3</time_frame>
    <description>Cohort A</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Clinical Global Impression - Severity of Illness (CGI-S) score</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>Cohort A</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Global Impression - Global Improvement (CGI-I)</measure>
    <time_frame>Week 12</time_frame>
    <description>Cohort A</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>y-glutamyl transferase (y-GT)</measure>
    <time_frame>Week 12</time_frame>
    <description>Cohort A</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alanine aminotransferase (ALT)</measure>
    <time_frame>Week 12</time_frame>
    <description>Cohort A</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aspartate aminotransferase (AST)</measure>
    <time_frame>Week 12</time_frame>
    <description>Cohort A</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in 36-item Short-form Health Survey version 2 (SF-36) (only for patients in France and the United Kingdom)</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>Cohort A</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">378</enrollment>
  <condition>Alcohol Dependence</condition>
  <arm_group>
    <arm_group_label>Selincro® 18 mg with continuous psychosocial support: Cohort A</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Selincro® as-needed; tablets, orally, 12-week Treatment Period in conjunction with continuous psychosocial support</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Initial psychosocial support: Cohort B</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Initial psychosocial support followed by usual care practice, 12-week Observational Period</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Selincro® 18 mg with continuous psychosocial support: Cohort A</intervention_name>
    <arm_group_label>Selincro® 18 mg with continuous psychosocial support: Cohort A</arm_group_label>
    <other_name>nalmefene</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Initial psychosocial support: Cohort B</intervention_name>
    <arm_group_label>Initial psychosocial support: Cohort B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        To ensure the study is broadly representative of primary care clinical practice, minimal&#xD;
        inclusion and exclusion criteria are imposed with the main exclusion criteria relating to&#xD;
        contraindications to the prescription of Selincro® and reflecting the indication wording in&#xD;
        the SmPC.&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  The patient has alcohol dependence diagnosed according to ICD-10.&#xD;
&#xD;
          -  The patient has had a high DRL in the 4 weeks preceding the Screening Visit.&#xD;
&#xD;
          -  The patient is a man or woman, aged ≥18 years.&#xD;
&#xD;
          -  The patient provides a stable address and telephone number.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The patient has one or more contraindications to the prescription of Selincro®:&#xD;
&#xD;
               -  hypersensitivity to the active substance or to any of the excipients&#xD;
&#xD;
               -  taking opioid analgesics&#xD;
&#xD;
               -  current or recent opioid addiction&#xD;
&#xD;
               -  acute symptoms of opioid withdrawal&#xD;
&#xD;
               -  recent use of opioids suspected&#xD;
&#xD;
               -  severe hepatic impairment (Child-Pugh classification)&#xD;
&#xD;
               -  severe renal impairment (eGFR &lt;30 ml/min per 1.73 m2)&#xD;
&#xD;
               -  a recent history of acute alcohol withdrawal syndrome (including hallucinations,&#xD;
                  seizures, or delirium tremens)&#xD;
&#xD;
          -  The patient has had &lt;6 HDDs (defined by the European Medicines Agency as a day with an&#xD;
             alcohol consumption &gt;60g for men or &gt;40g for women) in the 4 weeks preceding the&#xD;
             Screening Visit.&#xD;
&#xD;
          -  The patient has physical alcohol withdrawal symptoms and requires immediate&#xD;
             detoxification for which inpatient treatment is required.&#xD;
&#xD;
          -  The patient is currently participating or has recently (in the 4 weeks preceding the&#xD;
             Screening Visit) participated in a treatment or support programme for alcohol-use&#xD;
             disorders, including Alcohol Anonymous, detoxification treatment, and treatment of&#xD;
             alcohol withdrawal symptoms, or the patient is already taking nalmefene or has taken&#xD;
             nalmefene in the 6 months preceding the Screening Visit.&#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>Email contact via H. Lundbeck A/S</last_name>
    <role>Study Director</role>
    <affiliation>LundbeckClinicalTrials@lundbeck.com</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>FR010</name>
      <address>
        <city>Becon-les-Granits</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FR001</name>
      <address>
        <city>Bordeaux</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FR005</name>
      <address>
        <city>Bordeaux</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FR009</name>
      <address>
        <city>Cestas</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FR012</name>
      <address>
        <city>Chauny</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FR002</name>
      <address>
        <city>Coulounieix-Chamiers</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FR008</name>
      <address>
        <city>La Teste De Buch</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FR007</name>
      <address>
        <city>Mont de Marsan</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FR011</name>
      <address>
        <city>Narbonne</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FR003</name>
      <address>
        <city>Targon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FR006</name>
      <address>
        <city>Tonneins</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FR004</name>
      <address>
        <city>Vieux Boucau</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DE002</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DE005</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DE006</name>
      <address>
        <city>Essen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DE003</name>
      <address>
        <city>Jahnsdorf</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DE004</name>
      <address>
        <city>Jahnsdorf</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DE011</name>
      <address>
        <city>Mannheim</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DE009</name>
      <address>
        <city>Nurnberg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DE010</name>
      <address>
        <city>Offenbach</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DE001</name>
      <address>
        <city>Wallerfing</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DE007</name>
      <address>
        <city>Weilburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DE008</name>
      <address>
        <city>Weinheim</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ES001</name>
      <address>
        <city>Badalona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ES010</name>
      <address>
        <city>Badalona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ES003</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ES004</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ES008</name>
      <address>
        <city>Canet de Mar</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ES007</name>
      <address>
        <city>El Prat de Llobregat</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ES006</name>
      <address>
        <city>Hospitalet del Llobregat</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ES009</name>
      <address>
        <city>Hospitalet del Llobregat</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ES011</name>
      <address>
        <city>Hospitalet del Llobregat</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ES002</name>
      <address>
        <city>Mataro</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ES013</name>
      <address>
        <city>Matar</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ES012</name>
      <address>
        <city>Sabadell</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ES005</name>
      <address>
        <city>Tarragona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GB011</name>
      <address>
        <city>Ballymena</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GB008</name>
      <address>
        <city>Belfast</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GB009</name>
      <address>
        <city>Belfast</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GB004</name>
      <address>
        <city>Cardiff</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GB005</name>
      <address>
        <city>Cardiff</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GB001</name>
      <address>
        <city>Coatbridge</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GB002</name>
      <address>
        <city>Glasgow</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GB003</name>
      <address>
        <city>Lanarkshire</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GB006</name>
      <address>
        <city>Swansea</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GB007</name>
      <address>
        <city>Swansea</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GB010</name>
      <address>
        <city>Swansea</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GB106</name>
      <address>
        <city>Swansea</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
    <country>Germany</country>
    <country>Spain</country>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>https://www.clinicaltrialsregister.eu/ctr-search/trial/2013-004688-30/results</url>
    <description>EMA EudraCT Results: 2013-004688-30</description>
  </link>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>July 17, 2014</study_first_submitted>
  <study_first_submitted_qc>July 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 21, 2014</study_first_posted>
  <last_update_submitted>February 27, 2017</last_update_submitted>
  <last_update_submitted_qc>February 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">February 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alcoholism</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nalmefene</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/NCT02195817
org study id: 15892A
secondary id: 2013-004688-30
nct id: NCT02195817
lead sponsor: 
has dmc: No
To determine the reduction in alcohol consumption in patients with alcohol dependence treated
      with 18 mg Selincro® as-needed use, in conjunction with continuous psychosocial support in
      primary care
635 patients are planned (total number of patients) with 475 patients treated with Selincro®
      (Cohort A) and 160 patients not treated with Selincro® (Cohort B) to determine the reduction
      in alcohol consumption in patients with alcohol dependence.

      Cohort A will comprise patients who maintain a high drinking risk level (DRL, defined by
      World Health Organization (WHO) as >60g alcohol/day for a man or >40g alcohol/day for a
      woman), or above, in the period between the Screening and Inclusion Visits.

      Cohort B will comprise patients who reduce their alcohol consumption in the period between
      the Screening and Inclusion visits, that is, patients who do not maintain at least a high DRL
      at the Inclusion Visit (and are therefore not eligible for treatment with nalmefene according
      to the SmPC).
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in the number of Heavy Drinking Days (HDDs) (days/month)
time frame: Baseline to Month 3
description: Cohort A
measure: Change in Total Alcohol Consumption (TAC) (g/day)
time frame: Baseline to Month 3
description: Cohort A
measure: Drinking Risk Level response (RSDRL); defined as a downward shift in Drinking Risk Level (DRL); for patients with a very high DRL at baseline, a shift to medium DRL or below; for patients with a high DRL at baseline, a shift to low DRL or below
time frame: Baseline to Month 3
description: Cohort A
measure: RLDRL response; defined as a downward shift in DRL to low DRL or below
time frame: Baseline to Month 3
description: Cohort A
measure: Response defined as ≥70% reduction in TAC
time frame: Baseline to Month 3
description: Cohort A
measure: Response defined as 0 to 4 HDDs (days/month)
time frame: Month 3
description: Cohort A
measure: Change in Clinical Global Impression - Severity of Illness (CGI-S) score
time frame: Baseline to Week 12
description: Cohort A
measure: Clinical Global Impression - Global Improvement (CGI-I)
time frame: Week 12
description: Cohort A
measure: y-glutamyl transferase (y-GT)
time frame: Week 12
description: Cohort A
measure: Alanine aminotransferase (ALT)
time frame: Week 12
description: Cohort A
measure: Aspartate aminotransferase (AST)
time frame: Week 12
description: Cohort A
measure: Change in 36-item Short-form Health Survey version 2 (SF-36) (only for patients in France and the United Kingdom)
time frame: Baseline to Week 12
description: Cohort A
arm group label: Selincro® 18 mg with continuous psychosocial support: Cohort A
arm group type: Other
description: Selincro® as-needed; tablets, orally, 12-week Treatment Period in conjunction with continuous psychosocial support
arm group label: Initial psychosocial support: Cohort B
arm group type: Other
description: Initial psychosocial support followed by usual care practice, 12-week Observational Period
intervention type: Drug
intervention name: Selincro® 18 mg with continuous psychosocial support: Cohort A
arm group label: Selincro® 18 mg with continuous psychosocial support: Cohort A
other name: nalmefene
intervention type: Other
intervention name: Initial psychosocial support: Cohort B
arm group label: Initial psychosocial support: Cohort B
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Email contact via H. Lundbeck A/S
role: Study Director
affiliation: LundbeckClinicalTrials@lundbeck.com
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
country: Germany
country: Spain
country: United Kingdom
url: https://www.clinicaltrialsregister.eu/ctr-search/trial/2013-004688-30/results
description: EMA EudraCT Results: 2013-004688-30
responsible party type: Sponsor
mesh term: Alcoholism
mesh term: Nalmefene