<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/NCT03034408</url>
  </required_header>
  <id_info>
    <org_study_id>2015-00160</org_study_id>
    <nct_id>NCT03034408</nct_id>
  </id_info>
  <brief_title>Nalmefene, Baclofen and Impulsivity in Subjects With Alcohol Use Disorder and Healthy Control Subjects</brief_title>
  <official_title>Effects of Nalmefene and Baclofen on Impulsivity in Subjects With Alcohol Use Disorder and Healthy Control Subjects: A Randomized, Placebo-controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Prof. Daniele Zullino</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Geneva</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Impulsivity is a central feature of addiction. Nalmefen is an authorized treatment for&#xD;
      alcohol addiction. Baclofen has empathically been advocated to have some efficacy in this&#xD;
      indication. The aim of the present study is to test the effect of Nalmefene and Baclofen on&#xD;
      impulsivity.&#xD;
&#xD;
      Primary study objective: To examine the effect of Nalmefene and Baclofen on impulsivity (as&#xD;
      measured by the Stop Signal Task) in subjects with alcohol use disorder and healthy control&#xD;
      subjects.&#xD;
&#xD;
      Main secondary study objectives: To examine the effect of Nalmefene and Baclofen on risk&#xD;
      taking (as measured by the Balloon Analogue Risk Task) and on the preference for small&#xD;
      immediate rewards over large delayed rewards (as measured by the Delay Discounting Task). To&#xD;
      compare subjects with alcohol use disorder and healthy control subjects on these tasks.&#xD;
&#xD;
      Primary study outcome: Stop-signal reaction time in the Stop-Signal Task Main secondary study&#xD;
      outcomes: Equivalence point in the Delay-Discounting Task and Average number of pumps&#xD;
      delivered in the Balloon Analogue Risk Task&#xD;
&#xD;
      Study Design: Randomized, placebo control, cross-over, single-dose&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 1, 2016</start_date>
  <completion_date type="Actual">December 17, 2018</completion_date>
  <primary_completion_date type="Actual">December 17, 2018</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in &quot;Stop-signal reaction time&quot; in the Stop-Signal Task</measure>
    <time_frame>0 and 2 hours post-dose</time_frame>
    <description>Before-drug/after-drug difference of the stop-signal reaction time in the Stop Signal Task at Visit 2, Visit 3 and Visit 4.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in &quot;Equivalence point&quot; in the Delay-Discounting Task</measure>
    <time_frame>0 and 2 hours post-dose</time_frame>
    <description>Before-drug/after-drug difference of the Equivalence point&quot; in the Delay-Discounting Task at Visit 2, Visit 3 and Visit 4.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in &quot;Average number of pumps&quot; delivered in the Balloon Analogue Risk Task</measure>
    <time_frame>0 and 2 hours post-dose</time_frame>
    <description>Before-drug/after-drug difference of the &quot;Average number of pumps&quot; delivered in the Balloon Analogue Risk Task at Visit 2, Visit 3 and Visit 4.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">37</enrollment>
  <condition>Alcohol Use Disorder</condition>
  <arm_group>
    <arm_group_label>Alcohol Use Disorder</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>30 patients with DSM-5 Diagnosis of Alcohol Use Disorder, at least moderate (303.90/F10.20) : Nalmefene 18mg, Baclofen 10mg, Placebo Oral Capsule</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>30 sex and age-matched healthy controls : Nalmefene 18mg, Baclofen 10mg, Placebo Oral Capsule</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nalmefene</intervention_name>
    <arm_group_label>Alcohol Use Disorder</arm_group_label>
    <arm_group_label>Healthy Control</arm_group_label>
    <other_name>Selincro</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Baclofen</intervention_name>
    <arm_group_label>Alcohol Use Disorder</arm_group_label>
    <arm_group_label>Healthy Control</arm_group_label>
    <other_name>Lioresal</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Oral Capsule</intervention_name>
    <arm_group_label>Alcohol Use Disorder</arm_group_label>
    <arm_group_label>Healthy Control</arm_group_label>
    <other_name>Mannitol</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  30 patients with DSM-5 Diagnosis of Alcohol Use Disorder, at least moderate&#xD;
             (303.90/F10.20),&#xD;
&#xD;
          -  30 sex and age-matched healthy controls,&#xD;
&#xD;
          -  over 18, informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  opiate-treatment,&#xD;
&#xD;
          -  contra-indications for Nalmefene and/or Baclofen,&#xD;
&#xD;
          -  unstable psychiatric disorder,&#xD;
&#xD;
          -  pregnancy,&#xD;
&#xD;
          -  acute withdrawal syndrome.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniele F Zullino, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Geneva</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Service d'Addictologie, Hôpitaux Universitaires de Genève</name>
      <address>
        <city>Geneva</city>
        <zip>1202</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <link>
    <url>http://www.hug-ge.ch/addictologie/recherche</url>
    <description>website related to the study</description>
  </link>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>November 3, 2016</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>October 28, 2020</last_update_submitted>
  <last_update_submitted_qc>October 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Geneva</investigator_affiliation>
    <investigator_full_name>Prof. Daniele Zullino</investigator_full_name>
    <investigator_title>Prof.</investigator_title>
  </responsible_party>
  <keyword>Impulsivity</keyword>
  <keyword>Nalmefene</keyword>
  <keyword>Baclofen</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alcoholism</mesh_term>
    <mesh_term>Alcohol Drinking</mesh_term>
    <mesh_term>Impulsive Behavior</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mannitol</mesh_term>
    <mesh_term>Baclofen</mesh_term>
    <mesh_term>Nalmefene</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/NCT03034408
org study id: 2015-00160
nct id: NCT03034408
lead sponsor: 
has dmc: Yes
Impulsivity is a central feature of addiction. Nalmefen is an authorized treatment for
      alcohol addiction. Baclofen has empathically been advocated to have some efficacy in this
      indication. The aim of the present study is to test the effect of Nalmefene and Baclofen on
      impulsivity.

      Primary study objective: To examine the effect of Nalmefene and Baclofen on impulsivity (as
      measured by the Stop Signal Task) in subjects with alcohol use disorder and healthy control
      subjects.

      Main secondary study objectives: To examine the effect of Nalmefene and Baclofen on risk
      taking (as measured by the Balloon Analogue Risk Task) and on the preference for small
      immediate rewards over large delayed rewards (as measured by the Delay Discounting Task). To
      compare subjects with alcohol use disorder and healthy control subjects on these tasks.

      Primary study outcome: Stop-signal reaction time in the Stop-Signal Task Main secondary study
      outcomes: Equivalence point in the Delay-Discounting Task and Average number of pumps
      delivered in the Balloon Analogue Risk Task

      Study Design: Randomized, placebo control, cross-over, single-dose
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in "Stop-signal reaction time" in the Stop-Signal Task
time frame: 0 and 2 hours post-dose
description: Before-drug/after-drug difference of the stop-signal reaction time in the Stop Signal Task at Visit 2, Visit 3 and Visit 4.
measure: Change in "Equivalence point" in the Delay-Discounting Task
time frame: 0 and 2 hours post-dose
description: Before-drug/after-drug difference of the Equivalence point" in the Delay-Discounting Task at Visit 2, Visit 3 and Visit 4.
measure: Change in "Average number of pumps" delivered in the Balloon Analogue Risk Task
time frame: 0 and 2 hours post-dose
description: Before-drug/after-drug difference of the "Average number of pumps" delivered in the Balloon Analogue Risk Task at Visit 2, Visit 3 and Visit 4.
arm group label: Alcohol Use Disorder
arm group type: Other
description: 30 patients with DSM-5 Diagnosis of Alcohol Use Disorder, at least moderate (303.90/F10.20) : Nalmefene 18mg, Baclofen 10mg, Placebo Oral Capsule
arm group label: Healthy Control
arm group type: Other
description: 30 sex and age-matched healthy controls : Nalmefene 18mg, Baclofen 10mg, Placebo Oral Capsule
intervention type: Drug
intervention name: Nalmefene
arm group label: Alcohol Use Disorder
arm group label: Healthy Control
other name: Selincro
intervention type: Drug
intervention name: Baclofen
arm group label: Alcohol Use Disorder
arm group label: Healthy Control
other name: Lioresal
intervention type: Drug
intervention name: Placebo Oral Capsule
arm group label: Alcohol Use Disorder
arm group label: Healthy Control
other name: Mannitol
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Daniele F Zullino, MD
role: Principal Investigator
affiliation: University Hospital, Geneva
facility: 
country: Switzerland
url: http://www.hug-ge.ch/addictologie/recherche
description: website related to the study
responsible party type: Sponsor-Investigator
investigator affiliation: University Hospital, Geneva
investigator full name: Prof. Daniele Zullino
investigator title: Prof.
mesh term: Alcoholism
mesh term: Alcohol Drinking
mesh term: Impulsive Behavior
mesh term: Mannitol
mesh term: Baclofen
mesh term: Nalmefene
sharing ipd: No