<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/NCT03037749</url>
  </required_header>
  <id_info>
    <org_study_id>12-433</org_study_id>
    <nct_id>NCT03037749</nct_id>
  </id_info>
  <brief_title>Over-arousal as a Mechanism Between Alcohol and Intimate Partner Violence</brief_title>
  <official_title>Over-arousal as a Mechanism Between Alcohol and Intimate Partner Violence</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of New Mexico</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Mind Research Network</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of New Mexico</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Intimate partner violence (IPV) is a serious public health problem costing $8.3 billion per&#xD;
      year with over $6 billion in direct medical and mental health costs alone. Alcohol is present&#xD;
      in most incidents of IPV, and contributes to more frequent and severe IPV incidents. These&#xD;
      facts, coupled with the fact that there are no effective interventions for IPV, make&#xD;
      understanding mechanisms through which alcohol is associated with IPV critical.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Intimate partner violence (IPV) is a significant public health problem for which there are&#xD;
      currently no effective treatments. Alcohol use is present in most instances of IPV and is&#xD;
      associated with an increase in the frequency and severity of IPV. The investigators believe&#xD;
      that alcohol may be related to the increase in frequency and severity of IPV through a&#xD;
      process of over-arousal that results from the cortically and psychophysiological arousing&#xD;
      effects of alcohol during the ascending limb of intoxication and at peak Blood Alcohol&#xD;
      Concentration (BAC) compounded by the unique behavioral and affective patterns of violent&#xD;
      couples. The first aim of the proposal is to determine if increases in arousal after alcohol&#xD;
      exposure is potentiated by evocative partner stimuli and is greater for distressed violent&#xD;
      (DV) partners than distressed nonviolent (DNV) partners. A second aim is to determine if&#xD;
      alcohol induced arousal interferes with DV partners' ability to regulate emotion in response&#xD;
      to evocative partner stimuli compared to DNV partners. The proposed study is an experimental&#xD;
      comparison of the effects of alcohol on arousal and emotion regulation between 35 DV and 35&#xD;
      DNV partners. One partner from each DV couple will be pseudo-randomly selected and yoked to a&#xD;
      DNV partner of the same sex and comparable relationship satisfaction for participant in the&#xD;
      experiment. To test the overall hypothesis that over-arousal is a mechanism through which&#xD;
      alcohol is associated with increases in the frequency and severity of IPV, the selected&#xD;
      partners will participate in a counter-balanced placebo session and an alcohol administration&#xD;
      session during which electroencephalography (EEG), psychophysiology and pupillary response&#xD;
      measurements of arousal will be collected during an emotion regulation task. The data will be&#xD;
      analyzed using a repeated measures ANOVA with a between-subjects factor. The investigators&#xD;
      expect that DV partners will experience significantly greater arousal than DNV partners&#xD;
      during the evocative stimuli condition. The investigators also expect that DV partners will&#xD;
      experience greater difficulty regulating emotion during evocative stimuli than DNV partners&#xD;
      and that this effect will be compounded during the alcohol administration condition. Findings&#xD;
      from this study will provide firm evidence that alcohol is associated with IPV through a&#xD;
      mechanism of over-arousal and provide key targets for intervention to prevent future IPV. The&#xD;
      data from the current proposal will be used to test biofeedback as an adjunct to a novel&#xD;
      behavioral intervention to reduce drinking and increase behavioral flexibility in couples&#xD;
      with a history of IPV.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 27, 2015</start_date>
  <completion_date type="Actual">August 31, 2018</completion_date>
  <primary_completion_date type="Actual">August 31, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <intervention_model_description>Distressed violent and distressed nonviolent couples participate in a placebo-controlled alcohol administration study with an emotion-regulation task.</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Participants are given either an alcohol beverage or a placebo beverage.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>neurophysiological arousal collected via electroencephalography</measure>
    <time_frame>two years</time_frame>
    <description>electroencephalography. Each participant's individual neurophysiological responses will be collected and then aggregated at the conclusion of the study for between-group analyses. Greater alpha and beta frequencies relative to reduced to theta and delta frequencies indicate greater cortical arousal. The experimental conditions of this study will allow us to determine if distressed violent partners experience greater cortical arousal in certain conditions.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>neurophysiological arousal collected via electrocardiogram</measure>
    <time_frame>two years</time_frame>
    <description>respiratory sinus arrythymia. This is a measure of heart rate variability that is an index of a person's ability to regulate their emotion. The responses on this measure are evaluated against the comparison group. Each participant's individual neurophysiological responses will be collected and then aggregated at the conclusion of the study for between-group analyses.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>neurophysiological arousal collected via galvanic skin response</measure>
    <time_frame>two years</time_frame>
    <description>galvanic skin response. When people are neurophysiologically aroused, their skin sweats more. This responses on this measures these changes between conditions and groups, and are evaluated against the comparison group. Each participant's individual neurophysiological responses will be collected and then aggregated at the conclusion of the study for between-group analyses.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>neurophysiological response collected via respiration</measure>
    <time_frame>two years</time_frame>
    <description>respiration. When neurophysiologically aroused people breathe faster. This responses on this measure will are evaluated against the comparison group to determine if the distressed violent group is more neurophysiologically aroused in certain experimental conditions. Each participant's individual neurophysiological responses will be collected and then aggregated at the conclusion of the study for between-group analyses.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>neurophysiological response collected via eye tracking</measure>
    <time_frame>two years</time_frame>
    <description>pupillary response. When people are neurophysiologically aroused their pupils dilate. This responses on this measure are evaluated against the comparison group. Each participant's individual neurophysiological responses will be collected and then aggregated at the conclusion of the study for between-group analyses.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>emotion regulation</measure>
    <time_frame>two years</time_frame>
    <description>This is an experimental task that all participants in both the distressed violent group and the distressed nonviolent group complete. In the emotion regulation task, an comparison of the aggregated primary outcome measures will be compared between groups to determine if distressed violent participants experience greater neurophysiological arousal than distressed nonviolent participants.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">170</enrollment>
  <condition>Domestic Violence</condition>
  <condition>Alcohol Consumption</condition>
  <arm_group>
    <arm_group_label>Distressed Violent Partners</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Distressed violent partners engage in a placebo-controlled alcohol administration study with an emotion-regulation task.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Distressed Nonviolent Partners</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Distressed nonviolent partners engage in a placebo-controlled alcohol administration study with an emotion-regulation task.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Alcohol beverage</intervention_name>
    <description>Alcohol beverage</description>
    <arm_group_label>Distressed Nonviolent Partners</arm_group_label>
    <arm_group_label>Distressed Violent Partners</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo beverage</intervention_name>
    <description>Placebo beverage</description>
    <arm_group_label>Distressed Nonviolent Partners</arm_group_label>
    <arm_group_label>Distressed Violent Partners</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  English-speaking&#xD;
&#xD;
          -  Heterosexual,&#xD;
&#xD;
          -  Be in a distressed relationship&#xD;
&#xD;
          -  consume at least one to two alcoholic drinks per sitting each week for females and&#xD;
             three to four alcoholic drinks for males&#xD;
&#xD;
          -  report two binge drinking episodes (&gt;4 drinks for males, &gt;3 drinks for females) in&#xD;
             month prior to assessment&#xD;
&#xD;
          -  be married or cohabitating for at least six months&#xD;
&#xD;
          -  both partners must be willing to participate&#xD;
&#xD;
          -  must have a breath alcohol level of 0.0 g% at all visits.&#xD;
&#xD;
          -  Distressed Violent couples must have a history of at least mild physical aggression in&#xD;
             the past six months (e.g.,twisted partner's arm or hair).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  currently separated&#xD;
&#xD;
          -  an order of protection in place&#xD;
&#xD;
          -  facing violence-related criminal charges&#xD;
&#xD;
          -  currently in a domestic violence shelter&#xD;
&#xD;
          -  evidence of psychosis or severe personality disturbance&#xD;
&#xD;
          -  pregnant&#xD;
&#xD;
          -  taking a medication contraindicated for use with alcohol&#xD;
&#xD;
          -  currently taking insulin or oral hypoglycemic medication,&#xD;
&#xD;
          -  an AUDIT score greater than 19 indicating dependent drinking&#xD;
&#xD;
          -  illicit drug use (except marijuana)&#xD;
&#xD;
          -  provide a positive urinalysis at first emotion-regulation session&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Brandi C Fink, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of New Mexico</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Eric D. Claus, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Mind Research Network</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of New Mexico</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>April 19, 2016</study_first_submitted>
  <study_first_submitted_qc>January 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>January 4, 2019</last_update_submitted>
  <last_update_submitted_qc>January 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of New Mexico</investigator_affiliation>
    <investigator_full_name>Brandi Fink</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alcohol Drinking</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>February 25, 2022</submitted>
    <returned>March 22, 2022</returned>
    <submitted>July 22, 2022</submitted>
    <returned>August 19, 2022</returned>
    <submitted>May 11, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03037749
org study id: 12-433
nct id: NCT03037749
lead sponsor: 
collaborator: 
has dmc: No
Intimate partner violence (IPV) is a serious public health problem costing $8.3 billion per
      year with over $6 billion in direct medical and mental health costs alone. Alcohol is present
      in most incidents of IPV, and contributes to more frequent and severe IPV incidents. These
      facts, coupled with the fact that there are no effective interventions for IPV, make
      understanding mechanisms through which alcohol is associated with IPV critical.
Intimate partner violence (IPV) is a significant public health problem for which there are
      currently no effective treatments. Alcohol use is present in most instances of IPV and is
      associated with an increase in the frequency and severity of IPV. The investigators believe
      that alcohol may be related to the increase in frequency and severity of IPV through a
      process of over-arousal that results from the cortically and psychophysiological arousing
      effects of alcohol during the ascending limb of intoxication and at peak Blood Alcohol
      Concentration (BAC) compounded by the unique behavioral and affective patterns of violent
      couples. The first aim of the proposal is to determine if increases in arousal after alcohol
      exposure is potentiated by evocative partner stimuli and is greater for distressed violent
      (DV) partners than distressed nonviolent (DNV) partners. A second aim is to determine if
      alcohol induced arousal interferes with DV partners' ability to regulate emotion in response
      to evocative partner stimuli compared to DNV partners. The proposed study is an experimental
      comparison of the effects of alcohol on arousal and emotion regulation between 35 DV and 35
      DNV partners. One partner from each DV couple will be pseudo-randomly selected and yoked to a
      DNV partner of the same sex and comparable relationship satisfaction for participant in the
      experiment. To test the overall hypothesis that over-arousal is a mechanism through which
      alcohol is associated with increases in the frequency and severity of IPV, the selected
      partners will participate in a counter-balanced placebo session and an alcohol administration
      session during which electroencephalography (EEG), psychophysiology and pupillary response
      measurements of arousal will be collected during an emotion regulation task. The data will be
      analyzed using a repeated measures ANOVA with a between-subjects factor. The investigators
      expect that DV partners will experience significantly greater arousal than DNV partners
      during the evocative stimuli condition. The investigators also expect that DV partners will
      experience greater difficulty regulating emotion during evocative stimuli than DNV partners
      and that this effect will be compounded during the alcohol administration condition. Findings
      from this study will provide firm evidence that alcohol is associated with IPV through a
      mechanism of over-arousal and provide key targets for intervention to prevent future IPV. The
      data from the current proposal will be used to test biofeedback as an adjunct to a novel
      behavioral intervention to reduce drinking and increase behavioral flexibility in couples
      with a history of IPV.
allocation: Non-Randomized
intervention model: Factorial Assignment
intervention model description: Distressed violent and distressed nonviolent couples participate in a placebo-controlled alcohol administration study with an emotion-regulation task.
primary purpose: Basic Science
masking: Single (Participant)
masking description: Participants are given either an alcohol beverage or a placebo beverage.
measure: neurophysiological arousal collected via electroencephalography
time frame: two years
description: electroencephalography. Each participant's individual neurophysiological responses will be collected and then aggregated at the conclusion of the study for between-group analyses. Greater alpha and beta frequencies relative to reduced to theta and delta frequencies indicate greater cortical arousal. The experimental conditions of this study will allow us to determine if distressed violent partners experience greater cortical arousal in certain conditions.
measure: neurophysiological arousal collected via electrocardiogram
time frame: two years
description: respiratory sinus arrythymia. This is a measure of heart rate variability that is an index of a person's ability to regulate their emotion. The responses on this measure are evaluated against the comparison group. Each participant's individual neurophysiological responses will be collected and then aggregated at the conclusion of the study for between-group analyses.
measure: neurophysiological arousal collected via galvanic skin response
time frame: two years
description: galvanic skin response. When people are neurophysiologically aroused, their skin sweats more. This responses on this measures these changes between conditions and groups, and are evaluated against the comparison group. Each participant's individual neurophysiological responses will be collected and then aggregated at the conclusion of the study for between-group analyses.
measure: neurophysiological response collected via respiration
time frame: two years
description: respiration. When neurophysiologically aroused people breathe faster. This responses on this measure will are evaluated against the comparison group to determine if the distressed violent group is more neurophysiologically aroused in certain experimental conditions. Each participant's individual neurophysiological responses will be collected and then aggregated at the conclusion of the study for between-group analyses.
measure: neurophysiological response collected via eye tracking
time frame: two years
description: pupillary response. When people are neurophysiologically aroused their pupils dilate. This responses on this measure are evaluated against the comparison group. Each participant's individual neurophysiological responses will be collected and then aggregated at the conclusion of the study for between-group analyses.
measure: emotion regulation
time frame: two years
description: This is an experimental task that all participants in both the distressed violent group and the distressed nonviolent group complete. In the emotion regulation task, an comparison of the aggregated primary outcome measures will be compared between groups to determine if distressed violent participants experience greater neurophysiological arousal than distressed nonviolent participants.
arm group label: Distressed Violent Partners
arm group type: Experimental
description: Distressed violent partners engage in a placebo-controlled alcohol administration study with an emotion-regulation task.
arm group label: Distressed Nonviolent Partners
arm group type: Experimental
description: Distressed nonviolent partners engage in a placebo-controlled alcohol administration study with an emotion-regulation task.
intervention type: Drug
intervention name: Alcohol beverage
description: Alcohol beverage
arm group label: Distressed Nonviolent Partners
arm group label: Distressed Violent Partners
intervention type: Drug
intervention name: Placebo beverage
description: Placebo beverage
arm group label: Distressed Nonviolent Partners
arm group label: Distressed Violent Partners
criteria: 
gender: All
minimum age: 21 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Brandi C Fink, Ph.D.
role: Principal Investigator
affiliation: University of New Mexico
last name: Eric D. Claus, Ph.D.
role: Principal Investigator
affiliation: The Mind Research Network
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of New Mexico
investigator full name: Brandi Fink
investigator title: Assistant Professor
mesh term: Alcohol Drinking
submitted: February 25, 2022
returned: March 22, 2022
submitted: July 22, 2022
returned: August 19, 2022
submitted: May 11, 2023