<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/NCT03810950</url>
  </required_header>
  <id_info>
    <org_study_id>TRR265 A03-Pilot</org_study_id>
    <nct_id>NCT03810950</nct_id>
  </id_info>
  <brief_title>Psychobiology of Stress and Alcohol Craving</brief_title>
  <official_title>Physiological, Neural and Behavioral Correlates of Psychosocial Stress and Alcohol Craving</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Central Institute of Mental Health, Mannheim</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Project Group for Automation in Medicine and Biotechnology PAMB, Mannheim</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Central Institute of Mental Health, Mannheim</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this feasibility study the investigators are using a setup of stress-related body sensors&#xD;
      including established as well as innovative sensor-based measures to identify predictor&#xD;
      profiles for alcohol-related behavioral and neural measures in Alcohol Use Disorder (AUD).&#xD;
      Long-term aim is the definition of a setup of mobile sensors and their integration in a&#xD;
      mobile infrastructure that allows the prediction of stress related alcohol intake in an&#xD;
      ambulatory setting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The long-term aim is the definition of a setup of mobile sensors and their integration in a&#xD;
      mobile infrastructure that allows the prediction of stress related alcohol intake in an&#xD;
      ambulatory setting.&#xD;
&#xD;
      In patients with Alcohol Use Disorder (AUD) stress exposure is known to affect craving,&#xD;
      cue-reactivity and relapse risk. Here, the investigators aim to identify stress- and alcohol&#xD;
      cue-related physiological markers in a lab experiment to assess interactions between acute&#xD;
      psychological stress exposure and alcohol cue-exposure regarding their effects on alcohol&#xD;
      craving and related markers (attentional bias to alcohol-cues, implicit association task,&#xD;
      neural cue-reactivity). In addition to applying established stress-related markers (cortisol&#xD;
      in saliva, heart-rate variability, systolic blood pressure and electrodermal activity), the&#xD;
      investigators will integrate innovative measures currently under investigation (e.g. voice&#xD;
      stress analysis) to identify whether these additional parameters increase the predictive&#xD;
      significance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</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>change in heart rate</measure>
    <time_frame>at examination day: continuous measurement throughout the whole experiment (except during MRI scanning); duration around 2 hours; starting 1 hour 50 minutes after arrival of the proband</time_frame>
    <description>heart rate acquired with ear clip (continuous time series)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in heart rate variability</measure>
    <time_frame>at examination day: continuous measurement throughout the whole experiment (except during MRI scanning); duration around 2 hours; starting 1 hour 50 minutes after arrival of the proband</time_frame>
    <description>heart rate variability acquired with ear clip (continuous time series)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in blood pressure (systolic and diastolic)</measure>
    <time_frame>at examination day: 6 time points measured throughout the whole experiment (except during MRI scanning); at 2:20h, 2:50h, 3:20h, 3:50h, 4:50h, 5:05h after arrival of the proband</time_frame>
    <description>acquired with pressure sleeve</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in electrodermal activity</measure>
    <time_frame>at examination day: continuous measurement throughout the whole experiment (except during MRI scanning); duration around 2 hour; starting 1h 50min after arrival of the proband</time_frame>
    <description>time series acquired with body sensor</description>
  </primary_outcome>
  <primary_outcome>
    <measure>neural alcohol-related cue-reactivity</measure>
    <time_frame>at examination day: measured directly after the behavioral tasks at the end of the lab experiment</time_frame>
    <description>% signal change, measured with fMRI; paradigm Vollstädt-Klein et al. 2010 [% signal change is not a change over time; it is measured during one experimental session]</description>
  </primary_outcome>
  <primary_outcome>
    <measure>neural inhibition processing</measure>
    <time_frame>at examination day: measured directly after the behavioral tasks at the end of the lab experiment</time_frame>
    <description>% signal change, measured with fMRI; stop-signal reaction time task (Fauth-Buhler et al. 2012) [% signal change is not a change over time; it is measured during one experimental session]</description>
  </primary_outcome>
  <primary_outcome>
    <measure>neural emotion processing</measure>
    <time_frame>at examination day: measured directly after the behavioral tasks at the end of the lab experiment</time_frame>
    <description>% signal change, measured with fMRI; faces task (Hariri et al. 2002) [% signal change is not a change over time; it is measured during one experimental session]</description>
  </primary_outcome>
  <primary_outcome>
    <measure>resting state activity</measure>
    <time_frame>at examination day: measured directly after the behavioral tasks at the end of the lab experiment</time_frame>
    <description>resting state connectivity measured with fMRI</description>
  </primary_outcome>
  <primary_outcome>
    <measure>attentional bias to alcohol cues</measure>
    <time_frame>at examination day: measured directly after the stress task / newspaper reading; before &quot;implicit alcohol association&quot; and MRI session</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>implicit alcohol association</measure>
    <time_frame>at examination day: measured after the stress task / newspaper reading, directly after the &quot;attentional bias to alcohol cues&quot; ; before MRI session</time_frame>
    <description>measured with reaction time differences (in milliseconds) using the implicit association task (Wiers et al. 2016) [reaction time differences is not a change over time; it is measured during one experimental session]</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in level of cortisol</measure>
    <time_frame>at examination day: 6 time points measured throughout the whole experiment (except during MRI scanning); at hours:minutes 2:20, 2:50, 3:20, 3:50, 4:50, 5:05 after arrival of the proband</time_frame>
    <description>cortisol measured in saliva as a stress marker</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in voice stress pattern</measure>
    <time_frame>at examination day: 6 time points measured throughout the whole experiment (except during MRI scanning); at hours:minutes 2:20, 2:50, 3:20, 3:50, 4:50, 5:05 after arrival of the proband</time_frame>
    <description>audio file of participants' voice for voice stress pattern analysis will be recorded. From this a multivariate measure (i.e. multivariate vector) will be acquired (including frequency, loudness etc.)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in alcohol urges</measure>
    <time_frame>at examination day: 6 time points measured throughout the whole experiment (except during MRI scanning); at hours:minutes 2:20, 2:50, 3:20, 3:50, 4:50, 5:05 after arrival of the proband</time_frame>
    <description>elf-report questionnaire: &quot;Alcohol Urge Questionnaire (AUQ)&quot;; Bohn et al. 1995</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in alcohol craving</measure>
    <time_frame>at examination day: 6 time points measured throughout the whole experiment (except during MRI scanning); at hours:minutes 2:20, 2:50, 3:20, 3:50, 4:50, 5:05 after arrival of the proband</time_frame>
    <description>self-report &quot;How strong is your craving for alcohol?&quot;: reported on a visual analogue scale ranging from 0 to 100</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Alcohol Use Disorder</condition>
  <condition>Stress Reaction</condition>
  <condition>Social Stress</condition>
  <condition>Craving</condition>
  <condition>Behavior</condition>
  <arm_group>
    <arm_group_label>Social Stress Test</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants undergo the Trier Social Stress Test before Barlab-Exposure</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Condition</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants reads newspaper before Barlab-Exposure</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Trier Social Stress Test</intervention_name>
    <description>Test to induce high levels of acute social stress, including actors and a faked exam situation</description>
    <arm_group_label>Social Stress Test</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Reading Newspaper</intervention_name>
    <description>Participants read newspaper</description>
    <arm_group_label>Control Condition</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Barlab-Exposure</intervention_name>
    <description>Participants are exposed to a bar situation with different sorts of alcohol available. They sniff at water and at one alcoholic drink.</description>
    <arm_group_label>Control Condition</arm_group_label>
    <arm_group_label>Social Stress Test</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Heavy drinking, defined by alcohol consumption of at least 20g alcohol per day (at 5&#xD;
             days per week)&#xD;
&#xD;
          -  sufficient ability to communicate with the investigators, to answer questions in oral&#xD;
             and written form&#xD;
&#xD;
          -  fully informed consent&#xD;
&#xD;
          -  written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  withdrawal of the declaration of consent&#xD;
&#xD;
          -  positive urin drug screening (cannabis, amphetamine, opiates, benzodiazepines,&#xD;
             cocaine)&#xD;
&#xD;
          -  Lifetime history of DSM-5 bipolar disorder, schizophrenia or schizophrenia spectrum&#xD;
             disorder, or substance dependence other than alcohol or nicotine or cannabis&#xD;
             dependence.&#xD;
&#xD;
          -  Current threshold DSM-5 diagnosis of major depressive disorder, or presence of&#xD;
             suicidal intention&#xD;
&#xD;
          -  History of severe head trauma or other severe central nervous system disorder (e.g.,&#xD;
             dementia, Parkinson's disease, multiple sclerosis)&#xD;
&#xD;
          -  Current use of medications or drugs known to interact with the CNS within at least&#xD;
             four half-lives post last intake&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sabine Vollstädt-Klein, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Central Institute of Mental Health, Mannheim</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit</name>
      <address>
        <city>Mannheim</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>November 26, 2018</study_first_submitted>
  <study_first_submitted_qc>January 16, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 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>Fractures, Stress</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/NCT03810950
org study id: TRR265 A03-Pilot
nct id: NCT03810950
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
In this feasibility study the investigators are using a setup of stress-related body sensors
      including established as well as innovative sensor-based measures to identify predictor
      profiles for alcohol-related behavioral and neural measures in Alcohol Use Disorder (AUD).
      Long-term aim is the definition of a setup of mobile sensors and their integration in a
      mobile infrastructure that allows the prediction of stress related alcohol intake in an
      ambulatory setting.
The long-term aim is the definition of a setup of mobile sensors and their integration in a
      mobile infrastructure that allows the prediction of stress related alcohol intake in an
      ambulatory setting.

      In patients with Alcohol Use Disorder (AUD) stress exposure is known to affect craving,
      cue-reactivity and relapse risk. Here, the investigators aim to identify stress- and alcohol
      cue-related physiological markers in a lab experiment to assess interactions between acute
      psychological stress exposure and alcohol cue-exposure regarding their effects on alcohol
      craving and related markers (attentional bias to alcohol-cues, implicit association task,
      neural cue-reactivity). In addition to applying established stress-related markers (cortisol
      in saliva, heart-rate variability, systolic blood pressure and electrodermal activity), the
      investigators will integrate innovative measures currently under investigation (e.g. voice
      stress analysis) to identify whether these additional parameters increase the predictive
      significance.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: change in heart rate
time frame: at examination day: continuous measurement throughout the whole experiment (except during MRI scanning); duration around 2 hours; starting 1 hour 50 minutes after arrival of the proband
description: heart rate acquired with ear clip (continuous time series)
measure: change in heart rate variability
time frame: at examination day: continuous measurement throughout the whole experiment (except during MRI scanning); duration around 2 hours; starting 1 hour 50 minutes after arrival of the proband
description: heart rate variability acquired with ear clip (continuous time series)
measure: change in blood pressure (systolic and diastolic)
time frame: at examination day: 6 time points measured throughout the whole experiment (except during MRI scanning); at 2:20h, 2:50h, 3:20h, 3:50h, 4:50h, 5:05h after arrival of the proband
description: acquired with pressure sleeve
measure: change in electrodermal activity
time frame: at examination day: continuous measurement throughout the whole experiment (except during MRI scanning); duration around 2 hour; starting 1h 50min after arrival of the proband
description: time series acquired with body sensor
measure: neural alcohol-related cue-reactivity
time frame: at examination day: measured directly after the behavioral tasks at the end of the lab experiment
description: % signal change, measured with fMRI; paradigm Vollstädt-Klein et al. 2010 [% signal change is not a change over time; it is measured during one experimental session]
measure: neural inhibition processing
time frame: at examination day: measured directly after the behavioral tasks at the end of the lab experiment
description: % signal change, measured with fMRI; stop-signal reaction time task (Fauth-Buhler et al. 2012) [% signal change is not a change over time; it is measured during one experimental session]
measure: neural emotion processing
time frame: at examination day: measured directly after the behavioral tasks at the end of the lab experiment
description: % signal change, measured with fMRI; faces task (Hariri et al. 2002) [% signal change is not a change over time; it is measured during one experimental session]
measure: resting state activity
time frame: at examination day: measured directly after the behavioral tasks at the end of the lab experiment
description: resting state connectivity measured with fMRI
measure: attentional bias to alcohol cues
time frame: at examination day: measured directly after the stress task / newspaper reading; before "implicit alcohol association" and MRI session
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: implicit alcohol association
time frame: at examination day: measured after the stress task / newspaper reading, directly after the "attentional bias to alcohol cues" ; before MRI session
description: measured with reaction time differences (in milliseconds) using the implicit association task (Wiers et al. 2016) [reaction time differences is not a change over time; it is measured during one experimental session]
measure: change in level of cortisol
time frame: at examination day: 6 time points measured throughout the whole experiment (except during MRI scanning); at hours:minutes 2:20, 2:50, 3:20, 3:50, 4:50, 5:05 after arrival of the proband
description: cortisol measured in saliva as a stress marker
measure: change in voice stress pattern
time frame: at examination day: 6 time points measured throughout the whole experiment (except during MRI scanning); at hours:minutes 2:20, 2:50, 3:20, 3:50, 4:50, 5:05 after arrival of the proband
description: audio file of participants' voice for voice stress pattern analysis will be recorded. From this a multivariate measure (i.e. multivariate vector) will be acquired (including frequency, loudness etc.)
measure: change in alcohol urges
time frame: at examination day: 6 time points measured throughout the whole experiment (except during MRI scanning); at hours:minutes 2:20, 2:50, 3:20, 3:50, 4:50, 5:05 after arrival of the proband
description: elf-report questionnaire: "Alcohol Urge Questionnaire (AUQ)"; Bohn et al. 1995
measure: change in alcohol craving
time frame: at examination day: 6 time points measured throughout the whole experiment (except during MRI scanning); at hours:minutes 2:20, 2:50, 3:20, 3:50, 4:50, 5:05 after arrival of the proband
description: self-report "How strong is your craving for alcohol?": reported on a visual analogue scale ranging from 0 to 100
arm group label: Social Stress Test
arm group type: Experimental
description: Participants undergo the Trier Social Stress Test before Barlab-Exposure
arm group label: Control Condition
arm group type: Active Comparator
description: Participants reads newspaper before Barlab-Exposure
intervention type: Behavioral
intervention name: Trier Social Stress Test
description: Test to induce high levels of acute social stress, including actors and a faked exam situation
arm group label: Social Stress Test
intervention type: Behavioral
intervention name: Reading Newspaper
description: Participants read newspaper
arm group label: Control Condition
intervention type: Behavioral
intervention name: Barlab-Exposure
description: Participants are exposed to a bar situation with different sorts of alcohol available. They sniff at water and at one alcoholic drink.
arm group label: Control Condition
arm group label: Social Stress Test
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Sabine Vollstädt-Klein, Prof. Dr.
role: Principal Investigator
affiliation: Central Institute of Mental Health, Mannheim
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Alcoholism
mesh term: Fractures, Stress