<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/NCT03816527</url>
  </required_header>
  <id_info>
    <org_study_id>Emo-Dotprobe</org_study_id>
    <nct_id>NCT03816527</nct_id>
  </id_info>
  <brief_title>Selective Attention in Alcohol Use Disorder</brief_title>
  <official_title>Selective Attention to Emotional and Alcohol-associated Cues in Patients With Alcohol Use Disorder and Healthy Participants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Central Institute of Mental Health, Mannheim</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Central Institute of Mental Health, Mannheim</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study examines the selective attention to emotional- and alcohol- associated cues in&#xD;
      alcohol- dependant and healthy participants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The planned study will investigate the selective attention to emotional and alcohol-related&#xD;
      stimuli in alcohol-dependent patients and healthy volunteers.&#xD;
&#xD;
      background Attitudinal shifts in the implicit cognitive processing of alcohol-associated&#xD;
      stimuli play a major role in the maintenance of addictive disorders, in the development of&#xD;
      alcohol cravings, and ultimately in relapse. There are several experimental methods to study&#xD;
      the selective attention to image stimuli. For preliminary studies as well as for the planned&#xD;
      study, we opted for the so-called Dotprobe task , in which image pairs (alcohol versus&#xD;
      neutral stimulus) are presented. The selective attention can be measured by means of reaction&#xD;
      time differences. In addition to alcohol-related stimuli, photos of fearful and happy faces&#xD;
      that act as emotional stimuli are also used.&#xD;
&#xD;
      In a preliminary study, the investigators were able to show that not only alcoholics, but&#xD;
      also healthy light social drinkers, showed an initial orientation towards alcohol stimuli.&#xD;
      The presence of such a shift in attention to alcoholic stimuli, even in healthy individuals,&#xD;
      could be a consequence of the processing of alcoholic stimuli as emotional stimuli of&#xD;
      increased salience compared to affectively neutral stimuli. There are still no studies that&#xD;
      collectively examine selective attention to both emotional and alcohol-associated stimuli.&#xD;
      While some studies have shown selective attention to fear stimuli compared to neutral stimuli&#xD;
      only in populations with clinically relevant increased anxiety, there are also studies who&#xD;
      were able to show that there is selective attention to evolutionarily relevant anxiety even&#xD;
      in healthy individuals. In these non-clinical populations, this selective attention appears&#xD;
      to be particularly prevalent in subjects with increased anxiety.&#xD;
&#xD;
      Studies using affective positive stimuli such as happy faces showed selective attention to&#xD;
      these positive valent stimuli in healthy people compared to neutral stimuli, which was also&#xD;
      associated with the current mood . Thus, the selective attention to cheerful faces, for&#xD;
      example, in a positive mood was also increased. Emotional processing is relevant in the&#xD;
      development and maintenance of addictive diseases as well as in so-called &quot;prolonged&#xD;
      withdrawal&quot;. Thus, during abstinence among alcoholics, increased anxiety, irritability and&#xD;
      dysphoria, the so-called &quot;negative emotional state of withdrawal&quot;, appear. In a functional&#xD;
      Magnetic Resonance Imaging (fMRI) study, it was shown that when anxious faces were seen,&#xD;
      acute alcohol abuse had anxiolytic effects. In a separate study with disgusting images on&#xD;
      cigarette packs as an aversive fear stimuli, we found that smokers showed a shift in&#xD;
      attention to these disgusting images was associated with relief craving and was also&#xD;
      associated with increased anxiety, especially in heavy smokers.&#xD;
&#xD;
      Objective:&#xD;
&#xD;
      The study will compare the selective attention to emotional and alcohol-related stimuli&#xD;
      between alcoholics and healthy people. Furthermore, their association with positive and&#xD;
      negative mood as well as anxiety should be considered. The aim is to investigate whether&#xD;
      alcoholic stimuli are processed the same way in healthy people, such as appetitive, emotional&#xD;
      stimuli and whether patients' alcohol stimuli are processed like aversive, emotional stimuli.&#xD;
&#xD;
      This question is interesting both methodically and clinically. On the one hand, it would be&#xD;
      methodologically important to interpret whether healthy alcohol-associated stimuli are&#xD;
      appetitive or similar to affectively positive stimuli for the interpretation of studies on&#xD;
      selective attention to alcohol stimuli and alcohol-stimulant reactivity. Clinically&#xD;
      significant would be the identification of patients with increased selective attention to&#xD;
      alcohol and anxiety stimuli, for whom the risk of relapse could be increased by confronting&#xD;
      these stimuli. From these findings, therapeutic options could be derived, such as the&#xD;
      application of exposure therapies.&#xD;
&#xD;
      Hypotheses:&#xD;
&#xD;
        1. Alcohol-dependent patients as well as healthy volunteers have a selective shift of&#xD;
           attention to alcohol-associated versus neutral stimuli.&#xD;
&#xD;
        2. The selective attention to happy faces is associated with positive mood.&#xD;
&#xD;
        3. The selective attention to anxious faces is associated with the degree of anxiety.&#xD;
&#xD;
        4. The selective attention to anxious faces is increased in alcoholics compared to healthy&#xD;
           controls.&#xD;
&#xD;
        5. The selective attention to happy faces is lowered in alcoholics in comparison to healthy&#xD;
           controls.&#xD;
&#xD;
        6. Selective attention to alcohol-associated stimuli in healthy controls is associated with&#xD;
           positive mood.&#xD;
&#xD;
        7. Selective attention to alcohol-related stimuli is associated with negative mood in&#xD;
           alcohol-dependent patients.&#xD;
&#xD;
      Target population:&#xD;
&#xD;
      The study will examine 40 alcohol-dependent patients and 40 healthy volunteers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>attentional bias to alcohol cues</measure>
    <time_frame>at examination 1 day (single examination, no follow-up)</time_frame>
    <description>measured with reaction time differences (in milliseconds) using the dotprobe-task (Vollstädt-Klein et al. 2009) [reaction time differences is not a change over time; it is measured during one experimental session]</description>
  </primary_outcome>
  <primary_outcome>
    <measure>attentional bias to emotional cues</measure>
    <time_frame>at examination 1 day (single examination, no follow-up)</time_frame>
    <description>measured with reaction time differences (in milliseconds) using the dotprobe-task (like in Vollstädt-Klein et al. 2009, but with emotional pictures) [reaction time differences is not a change over time; it is measured during one experimental session]</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>severity of nicotine dependence</measure>
    <time_frame>at examination 1 day (single examination, no follow-up)</time_frame>
    <description>Fagerstrøm Test of Nicotine Dependence (Heatherton, Kozlowski, Frecker, &amp; Fagerstrom, 1991)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>nicotine consumption</measure>
    <time_frame>at examination 1 day (single examination, no follow-up), retrospectively for the last 3 months</time_frame>
    <description>amount of nicotine consumed during the last 3 months (like (Scheurich et al., 2005) but for nicotine instead of alcohol)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>alcohol consumption</measure>
    <time_frame>at examination 1 day (single examination, no follow-up), retrospectively for the last 3 months</time_frame>
    <description>amount of alcohol consumed during the last 3 months (Scheurich et al., 2005)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>severity of alcohol use disorder</measure>
    <time_frame>at examination 1 day (single examination, no follow-up),</time_frame>
    <description>Alcohol Dependence Scale, ADS (Skinner &amp; Horn, 1984), score ranges between 0 and 47, higher score means higher severity of alcohol use disorder</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>habitual alcohol consumption</measure>
    <time_frame>at examination 1 day (single examination, no follow-up), retrospectively for the last 7 days</time_frame>
    <description>automated and habitual alcohol consumption during the last 7 days, measured with Craving Automated Scale for Alcohol&quot; (CAS-A) (Vollstädt-Klein et al., 2015). 5 subscales (factors): Factor 1 (&quot;only aware in hindsight&quot;) ranges from 0 to 35, factor 2 (&quot;no deliberate decision&quot;) from 0 to 35, factor 3 (&quot;contrary to intention&quot;) from 0 to 40, factor 4 (&quot;no perception&quot;) from 0 to 20, and factor 5 (&quot;no control&quot;) from 0 to 10. , higher score means more habitual alcohol consumption</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>alcohol craving</measure>
    <time_frame>at examination 1 day (single examination, no follow-up), retrospectively for the last 7 days</time_frame>
    <description>measured with Obsessive Compulsive Drinking Scale (OCDS, (Mann &amp; Ackermann, 2000)), score ranges between 0 and 40, higher score means higher craving (obsessive-compulsive alcohol use)</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Alcohol Use Disorder</condition>
  <arm_group>
    <arm_group_label>AUD patients</arm_group_label>
    <description>Individuals with alcohol use disorder</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy controls</arm_group_label>
    <description>Healthy controls</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        group 1: patients with alcohol use disorder, recruited in the Clinic of the Department of&#xD;
        Addictive Behaviour and Addiction Medicine group 2: healthy controls, recruited from the&#xD;
        local community&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women of childbearing age&#xD;
&#xD;
          -  Women an Men between 18 and 65 years&#xD;
&#xD;
          -  Adequate ability to reach an Agreement with the Investigator, to answer oral and&#xD;
             written questions&#xD;
&#xD;
          -  Ability to consent after detailed reconnaissance&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
          -  Patients: Diagnosis of alcohol use disorder&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants wich are unable to consent&#xD;
&#xD;
          -  Severe internal, neurological ans psychiatric comorbidities&#xD;
&#xD;
          -  Abstinence phenomenon (CIWA-R &gt; 3)&#xD;
&#xD;
          -  Axis I psychiatric disorder (except nicotine dependence and specific phobias within&#xD;
             the last 12 months as well as patients with alcohol use disorder)&#xD;
&#xD;
          -  Pharmacotherapy with psychoactive substances&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sabine Vollstädt-Klein</last_name>
    <role>Principal Investigator</role>
    <affiliation>ZI Mannheim</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sabine Vollstädt-Klein</last_name>
    <phone>0621 / 17033912</phone>
    <email>sabine.vollstaedt-klein@zi-mannheim.de</email>
  </overall_contact>
  <location>
    <facility>
      <name>Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit</name>
      <address>
        <city>Mannheim</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sabine Vollstädt-Klein</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>January 24, 2023</last_update_submitted>
  <last_update_submitted_qc>January 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 26, 2023</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>
    <mesh_term>Alcohol Drinking</mesh_term>
  </condition_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/NCT03816527
org study id: Emo-Dotprobe
nct id: NCT03816527
lead sponsor: 
has dmc: No
This study examines the selective attention to emotional- and alcohol- associated cues in
      alcohol- dependant and healthy participants.
The planned study will investigate the selective attention to emotional and alcohol-related
      stimuli in alcohol-dependent patients and healthy volunteers.

      background Attitudinal shifts in the implicit cognitive processing of alcohol-associated
      stimuli play a major role in the maintenance of addictive disorders, in the development of
      alcohol cravings, and ultimately in relapse. There are several experimental methods to study
      the selective attention to image stimuli. For preliminary studies as well as for the planned
      study, we opted for the so-called Dotprobe task , in which image pairs (alcohol versus
      neutral stimulus) are presented. The selective attention can be measured by means of reaction
      time differences. In addition to alcohol-related stimuli, photos of fearful and happy faces
      that act as emotional stimuli are also used.

      In a preliminary study, the investigators were able to show that not only alcoholics, but
      also healthy light social drinkers, showed an initial orientation towards alcohol stimuli.
      The presence of such a shift in attention to alcoholic stimuli, even in healthy individuals,
      could be a consequence of the processing of alcoholic stimuli as emotional stimuli of
      increased salience compared to affectively neutral stimuli. There are still no studies that
      collectively examine selective attention to both emotional and alcohol-associated stimuli.
      While some studies have shown selective attention to fear stimuli compared to neutral stimuli
      only in populations with clinically relevant increased anxiety, there are also studies who
      were able to show that there is selective attention to evolutionarily relevant anxiety even
      in healthy individuals. In these non-clinical populations, this selective attention appears
      to be particularly prevalent in subjects with increased anxiety.

      Studies using affective positive stimuli such as happy faces showed selective attention to
      these positive valent stimuli in healthy people compared to neutral stimuli, which was also
      associated with the current mood . Thus, the selective attention to cheerful faces, for
      example, in a positive mood was also increased. Emotional processing is relevant in the
      development and maintenance of addictive diseases as well as in so-called "prolonged
      withdrawal". Thus, during abstinence among alcoholics, increased anxiety, irritability and
      dysphoria, the so-called "negative emotional state of withdrawal", appear. In a functional
      Magnetic Resonance Imaging (fMRI) study, it was shown that when anxious faces were seen,
      acute alcohol abuse had anxiolytic effects. In a separate study with disgusting images on
      cigarette packs as an aversive fear stimuli, we found that smokers showed a shift in
      attention to these disgusting images was associated with relief craving and was also
      associated with increased anxiety, especially in heavy smokers.

      Objective:

      The study will compare the selective attention to emotional and alcohol-related stimuli
      between alcoholics and healthy people. Furthermore, their association with positive and
      negative mood as well as anxiety should be considered. The aim is to investigate whether
      alcoholic stimuli are processed the same way in healthy people, such as appetitive, emotional
      stimuli and whether patients' alcohol stimuli are processed like aversive, emotional stimuli.

      This question is interesting both methodically and clinically. On the one hand, it would be
      methodologically important to interpret whether healthy alcohol-associated stimuli are
      appetitive or similar to affectively positive stimuli for the interpretation of studies on
      selective attention to alcohol stimuli and alcohol-stimulant reactivity. Clinically
      significant would be the identification of patients with increased selective attention to
      alcohol and anxiety stimuli, for whom the risk of relapse could be increased by confronting
      these stimuli. From these findings, therapeutic options could be derived, such as the
      application of exposure therapies.

      Hypotheses:

        1. Alcohol-dependent patients as well as healthy volunteers have a selective shift of
           attention to alcohol-associated versus neutral stimuli.

        2. The selective attention to happy faces is associated with positive mood.

        3. The selective attention to anxious faces is associated with the degree of anxiety.

        4. The selective attention to anxious faces is increased in alcoholics compared to healthy
           controls.

        5. The selective attention to happy faces is lowered in alcoholics in comparison to healthy
           controls.

        6. Selective attention to alcohol-associated stimuli in healthy controls is associated with
           positive mood.

        7. Selective attention to alcohol-related stimuli is associated with negative mood in
           alcohol-dependent patients.

      Target population:

      The study will examine 40 alcohol-dependent patients and 40 healthy volunteers.
observational model: Case-Control
time perspective: Prospective
measure: attentional bias to alcohol cues
time frame: at examination 1 day (single examination, no follow-up)
description: measured with reaction time differences (in milliseconds) using the dotprobe-task (Vollstädt-Klein et al. 2009) [reaction time differences is not a change over time; it is measured during one experimental session]
measure: attentional bias to emotional cues
time frame: at examination 1 day (single examination, no follow-up)
description: measured with reaction time differences (in milliseconds) using the dotprobe-task (like in Vollstädt-Klein et al. 2009, but with emotional pictures) [reaction time differences is not a change over time; it is measured during one experimental session]
measure: severity of nicotine dependence
time frame: at examination 1 day (single examination, no follow-up)
description: Fagerstrøm Test of Nicotine Dependence (Heatherton, Kozlowski, Frecker, & Fagerstrom, 1991)
measure: nicotine consumption
time frame: at examination 1 day (single examination, no follow-up), retrospectively for the last 3 months
description: amount of nicotine consumed during the last 3 months (like (Scheurich et al., 2005) but for nicotine instead of alcohol)
measure: alcohol consumption
time frame: at examination 1 day (single examination, no follow-up), retrospectively for the last 3 months
description: amount of alcohol consumed during the last 3 months (Scheurich et al., 2005)
measure: severity of alcohol use disorder
time frame: at examination 1 day (single examination, no follow-up),
description: Alcohol Dependence Scale, ADS (Skinner & Horn, 1984), score ranges between 0 and 47, higher score means higher severity of alcohol use disorder
measure: habitual alcohol consumption
time frame: at examination 1 day (single examination, no follow-up), retrospectively for the last 7 days
description: automated and habitual alcohol consumption during the last 7 days, measured with Craving Automated Scale for Alcohol" (CAS-A) (Vollstädt-Klein et al., 2015). 5 subscales (factors): Factor 1 ("only aware in hindsight") ranges from 0 to 35, factor 2 ("no deliberate decision") from 0 to 35, factor 3 ("contrary to intention") from 0 to 40, factor 4 ("no perception") from 0 to 20, and factor 5 ("no control") from 0 to 10. , higher score means more habitual alcohol consumption
measure: alcohol craving
time frame: at examination 1 day (single examination, no follow-up), retrospectively for the last 7 days
description: measured with Obsessive Compulsive Drinking Scale (OCDS, (Mann & Ackermann, 2000)), score ranges between 0 and 40, higher score means higher craving (obsessive-compulsive alcohol use)
arm group label: AUD patients
description: Individuals with alcohol use disorder
arm group label: Healthy controls
description: Healthy controls
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sabine Vollstädt-Klein
role: Principal Investigator
affiliation: ZI Mannheim
last name: Sabine Vollstädt-Klein
phone: 0621 / 17033912
email: sabine.vollstaedt-klein@zi-mannheim.de
facility: 
status: Recruiting
contact: 
country: Germany
responsible party type: Sponsor
mesh term: Alcoholism
mesh term: Alcohol Drinking