<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/NCT03028662</url>
  </required_header>
  <id_info>
    <org_study_id>2015-00463</org_study_id>
    <nct_id>NCT03028662</nct_id>
  </id_info>
  <brief_title>New Therapeutic Strategies for the Treatment of Alcohol Use Disorders</brief_title>
  <official_title>New Therapeutic Strategies for the Treatment of Alcohol Use Disorders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gabriel Rubio Valladolid, MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hospital Universitario 12 de Octubre</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Instituto de Salud Carlos III</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital Universitario 12 de Octubre</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an experimental study in which the efficacy of three psychophysiological intervention&#xD;
      modalities based on retrieval-extinction procedures is analyzed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Behavioral inhibition processes are a particularly relevant in relapses of patients with&#xD;
      alcohol dependence. One of the current behavioral techniques to improve inhibitory abilities&#xD;
      of these patients is the alcohol Approach Avoidance Task (AAT). However, this technique could&#xD;
      be more efficient if patients, before training in this task, were exposed to a variety of&#xD;
      alcohol-conditioned stimuli (retrieval) and take advantage of the window period of&#xD;
      reconsolidation of these memories to carry out this task (extinction training). This project&#xD;
      will attempt to show the pattern of brain connectivity underlying retrieval-extinction&#xD;
      learning, its relationship with markers such as Brain-Derived Neurotrophic Factor (BDNF) and&#xD;
      their usefulness to reduce relapses of individual with alcohol dependence. To carry out this&#xD;
      study 115 patients with alcohol dependence who will be randomized into three groups: Group 1&#xD;
      (N = 35) where the extinction training is performed within the window period (10 minutes);&#xD;
      Group 2 (N = 35) extinction will take place outside the time window (6 hours); Group 3 (N =&#xD;
      35), these subjects will be exposed to &quot;non-retrieval&quot; but with extinction-training within&#xD;
      the window period. Changes in connectivity will be assessed with Electroencephalogram (EEG)&#xD;
      at baseline and after 4 training sessions, using the HERMES platform. BDNF levels will be&#xD;
      determined as peripheral markers of neurogenesis. These changes will be are correlated with&#xD;
      relapses in the 12 weeks of follow-up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2016</start_date>
  <completion_date type="Actual">December 2020</completion_date>
  <primary_completion_date type="Actual">September 2020</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference between pattern of brain connectivity after training-extinction and basal level</measure>
    <time_frame>2 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of relapses during 3 months after training-extinction</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Difference between plasma levels of BDNF after training-extinction and basal level</measure>
    <time_frame>2 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference between attentional bias toward alcohol after training-extinction and basal level</measure>
    <time_frame>2 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference between behavioral inhibition after training-extinction and basal level</measure>
    <time_frame>2 days</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">115</enrollment>
  <condition>Alcoholism</condition>
  <arm_group>
    <arm_group_label>Immediate exposure</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Exposure to video on alcohol (update phase) followed (10 minutes) by the task of approach-avoidance of alcohol (extinction phase) (Retrieval-Extinction Learning), during 4 days of training.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Delayed exposure</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Exposure to a video of alcohol consumption (update phase) followed (6 hours) by the task of approach-avoidance of alcohol (extinction phase) (Retrieval-Extinction Learning), during 4 days of training.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No exposure</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Exposure to a video of neutral situations (update phase) followed (10 minutes) by the task of approach-avoidance of alcohol (extinction phase) (Retrieval-Extinction Learning), during 4 days of training.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Retrieval-Extinction Learning</intervention_name>
    <description>The intervention consists of the accomplishment of the task of approach-avoidance of alcohol during 4 days of training. Subjects are instructed to respond with an approach movement (pulling a lever) to neutral images and to respond with avoidance movement (pushing the lever) to images of alcohol.</description>
    <arm_group_label>Delayed exposure</arm_group_label>
    <arm_group_label>Immediate exposure</arm_group_label>
    <arm_group_label>No exposure</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Alcohol-dependent patients who have been detoxified and abstinent take 10-14 days.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who do not sign the informed consent.&#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>Gabriel Rubio Valladolid, Psychiatrist</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Universitario 12 de Octubre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Universitario 12 de Octubre</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <citation>Wiers RW, Eberl C, Rinck M, Becker ES, Lindenmeyer J. Retraining automatic action tendencies changes alcoholic patients' approach bias for alcohol and improves treatment outcome. Psychol Sci. 2011 Apr;22(4):490-7. doi: 10.1177/0956797611400615. Epub 2011 Mar 9.</citation>
    <PMID>21389338</PMID>
  </reference>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>October 11, 2016</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>March 7, 2023</last_update_submitted>
  <last_update_submitted_qc>March 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Universitario 12 de Octubre</investigator_affiliation>
    <investigator_full_name>Gabriel Rubio Valladolid, MD</investigator_full_name>
    <investigator_title>Psychiatrist, MD, PhD</investigator_title>
  </responsible_party>
  <keyword>Alcohol Dependence</keyword>
  <keyword>Brain Connectivity</keyword>
  <keyword>Inhibition</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alcoholism</mesh_term>
  </condition_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/NCT03028662
org study id: 2015-00463
nct id: NCT03028662
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
This is an experimental study in which the efficacy of three psychophysiological intervention
      modalities based on retrieval-extinction procedures is analyzed.
Behavioral inhibition processes are a particularly relevant in relapses of patients with
      alcohol dependence. One of the current behavioral techniques to improve inhibitory abilities
      of these patients is the alcohol Approach Avoidance Task (AAT). However, this technique could
      be more efficient if patients, before training in this task, were exposed to a variety of
      alcohol-conditioned stimuli (retrieval) and take advantage of the window period of
      reconsolidation of these memories to carry out this task (extinction training). This project
      will attempt to show the pattern of brain connectivity underlying retrieval-extinction
      learning, its relationship with markers such as Brain-Derived Neurotrophic Factor (BDNF) and
      their usefulness to reduce relapses of individual with alcohol dependence. To carry out this
      study 115 patients with alcohol dependence who will be randomized into three groups: Group 1
      (N = 35) where the extinction training is performed within the window period (10 minutes);
      Group 2 (N = 35) extinction will take place outside the time window (6 hours); Group 3 (N =
      35), these subjects will be exposed to "non-retrieval" but with extinction-training within
      the window period. Changes in connectivity will be assessed with Electroencephalogram (EEG)
      at baseline and after 4 training sessions, using the HERMES platform. BDNF levels will be
      determined as peripheral markers of neurogenesis. These changes will be are correlated with
      relapses in the 12 weeks of follow-up.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Difference between pattern of brain connectivity after training-extinction and basal level
time frame: 2 days
measure: Number of relapses during 3 months after training-extinction
time frame: 3 months
measure: Difference between plasma levels of BDNF after training-extinction and basal level
time frame: 2 days
measure: Difference between attentional bias toward alcohol after training-extinction and basal level
time frame: 2 days
measure: Difference between behavioral inhibition after training-extinction and basal level
time frame: 2 days
arm group label: Immediate exposure
arm group type: Experimental
description: Exposure to video on alcohol (update phase) followed (10 minutes) by the task of approach-avoidance of alcohol (extinction phase) (Retrieval-Extinction Learning), during 4 days of training.
arm group label: Delayed exposure
arm group type: Active Comparator
description: Exposure to a video of alcohol consumption (update phase) followed (6 hours) by the task of approach-avoidance of alcohol (extinction phase) (Retrieval-Extinction Learning), during 4 days of training.
arm group label: No exposure
arm group type: Active Comparator
description: Exposure to a video of neutral situations (update phase) followed (10 minutes) by the task of approach-avoidance of alcohol (extinction phase) (Retrieval-Extinction Learning), during 4 days of training.
intervention type: Behavioral
intervention name: Retrieval-Extinction Learning
description: The intervention consists of the accomplishment of the task of approach-avoidance of alcohol during 4 days of training. Subjects are instructed to respond with an approach movement (pulling a lever) to neutral images and to respond with avoidance movement (pushing the lever) to images of alcohol.
arm group label: Delayed exposure
arm group label: Immediate exposure
arm group label: No exposure
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gabriel Rubio Valladolid, Psychiatrist
role: Principal Investigator
affiliation: Hospital Universitario 12 de Octubre
facility: 
country: Spain
citation: Wiers RW, Eberl C, Rinck M, Becker ES, Lindenmeyer J. Retraining automatic action tendencies changes alcoholic patients' approach bias for alcohol and improves treatment outcome. Psychol Sci. 2011 Apr;22(4):490-7. doi: 10.1177/0956797611400615. Epub 2011 Mar 9.
PMID: 21389338
responsible party type: Sponsor-Investigator
investigator affiliation: Hospital Universitario 12 de Octubre
investigator full name: Gabriel Rubio Valladolid, MD
investigator title: Psychiatrist, MD, PhD
mesh term: Alcoholism
sharing ipd: No