<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/NCT02228486</url>
  </required_header>
  <id_info>
    <org_study_id>aCR</org_study_id>
    <nct_id>NCT02228486</nct_id>
  </id_info>
  <brief_title>Relapse Prevention in Alcohol Dependency by Transcranial Direct Current Stimulation Supported Cue Exposure Therapy</brief_title>
  <official_title>Alcohol Cue-Reactivity in Patients With Alcohol Dependency and Effects of Transcranial Direct Current Stimulation (tDCS) on Cue-exposure Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Tuebingen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital Tuebingen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Relapse is a major risk in substance abuse disorders, which is closely related to craving for&#xD;
      a substance, describing a strong urge for consumption. Cue-exposure therapy is an&#xD;
      intervention aiming at the reduction of perceived craving by repeated confrontation. It is&#xD;
      based on the assumption that craving drops after repeated exposure without the reinforcing&#xD;
      experience elicited by consumption. In the present study, patients with alcohol dependency&#xD;
      take part in nine cue-exposure training sessions. Each session consists of mood induction&#xD;
      reflecting a high risk situation with subsequent in vivo confrontation with one's preferred&#xD;
      alcoholic beverage followed by the training of coping strategies. During the cue-exposure,&#xD;
      patients focus on perceiving automatic responses to alcohol-related cues. We hypothesize that&#xD;
      especially patients exhibiting initially high reactions to such cues should profit from this&#xD;
      intervention the most. The reactions are measured on a subjective (craving) and physiological&#xD;
      level (hemodynamics of the prefrontal cortex, heart rate variability, electrodermal&#xD;
      activity). Furthermore, we want to strengthen the expected training effects during the&#xD;
      cue-exposure by an activating transcranial direct current stimulation of the dorsolateral&#xD;
      prefrontal cortex, which has been shown to be hypoactive in substance abuse disorders. We&#xD;
      investigate how the cue-exposure training affects the processing of alcoholic cues&#xD;
      (cue-reactivity) and its relation to clinical symptoms of alcohol dependency.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2014</start_date>
  <completion_date type="Anticipated">August 2016</completion_date>
  <primary_completion_date type="Anticipated">August 2016</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>alcohol consumption days</measure>
    <time_frame>six months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum subjective alcohol craving during alcohol cue-exposure (10-point scale)</measure>
    <time_frame>5 weeks</time_frame>
    <description>During alcohol cue-exposure, subjects rate the subjective craving regularly on a scale from 0 to 10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>subjective rating of self-efficacy (score on a 10 item-scale)</measure>
    <time_frame>6 months</time_frame>
    <description>questionnaire (General Self-Efficacy Scale, Schwarzer &amp; Jerusalem, 1995)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Hemodynamics in the orbitofrontal cortex and the dorsolateral prefrontal cortex during cue-exposure</measure>
    <time_frame>5 weeks</time_frame>
    <description>With near-infrared spectroscopy, changes in the concentrations of oxygenated (O2HB) and deoxygenated (HHb) haemoglobin are assessed (in mmol*mm), peaks in those concentrations are evaluated</description>
  </other_outcome>
  <other_outcome>
    <measure>heart-rate variability during alcohol cue-exposure</measure>
    <time_frame>5 weeks</time_frame>
    <description>low frequency/ high frequency (LF/HF) power ratio and standard deviation of the duration between R-peaks (RR) during cue-exposure</description>
  </other_outcome>
  <other_outcome>
    <measure>Skin conductance level during alcohol cue exposure</measure>
    <time_frame>5 weeks</time_frame>
    <description>skin conductance level (SCL) in Mikrosiemens (μS)</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">48</enrollment>
  <condition>Alcohol Dependency</condition>
  <arm_group>
    <arm_group_label>Cue Exposure Therapy and verum tDCS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>During alcohol cue exposure, an active tDCS with a duration of 15 minutes and 2 mA is applied to the left dorsolateral prefrontal cortex (F3, anode) and a reference electrode placed over Fp2 (electrode positions determined by the international 10-20 system). The electrodes are rectangular (35cm2).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cue Exposure Therapy and sham tDCS</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>During alcohol cue exposure, a placebo tDCS is used with electrodes placed over the left dorsolateral prefrontal cortex (F3, anode) and a reference electrode placed over Fp2 (electrode positions determined by the international 10-20 system). The electrodes are rectangular (35cm2). There is a 20 second ramp going up until 2 mA and back to 0 again at the beginning and the end of the placebo stimulation with no active stimulation during the cue exposure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Waiting list control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The Cue-Reactivity of patients assigned to this arm will be measured twice with an interval of 5 weeks. Afterwards, patients will take part in the cue exposure therapy like subjects assigned to the active arms of the study</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>tDCS</intervention_name>
    <description>2 mA (verum group) over the left dorsolateral prefrontal cortex (F3, anodal), 15 min; 10 seconds ramp in verum and sham group (see also above)</description>
    <arm_group_label>Cue Exposure Therapy and verum tDCS</arm_group_label>
    <other_name>transcrancial direct currenct stimulation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cue Exposure Therapy</intervention_name>
    <description>5 weeks (9 sessions) of cue-exposure therapy with preferred alcoholic beverage (see also above)</description>
    <arm_group_label>Cue Exposure Therapy and sham tDCS</arm_group_label>
    <arm_group_label>Cue Exposure Therapy and verum tDCS</arm_group_label>
    <other_name>Cue-Exposure Training</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of an alcohol dependence (F10.2)&#xD;
&#xD;
          -  abstinence motivation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  epileptic seizures&#xD;
&#xD;
          -  acute psychotic episode&#xD;
&#xD;
          -  another substance use disorder besides nicotine dependency (F17.2)&#xD;
&#xD;
          -  acute withdrawal symptoms&#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>Ann-Christine Ehlis, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Tuebingen</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Agnes Kroczek, Dipl.-Psych.</last_name>
    <phone>0049 7071 29</phone>
    <phone_ext>82627</phone_ext>
    <email>Agnes.Kroczek@med.uni-tuebingen.de</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Psychiatry and Psychotherapy, University Hospital Tuebingen</name>
      <address>
        <city>Tuebingen</city>
        <state>Baden-Württemberg</state>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Agnes Kroczek, Dipl.-Psych.</last_name>
      <phone>0049 7071 29</phone>
      <phone_ext>82627</phone_ext>
      <email>Agnes.Kroczek@med.uni-tuebingen.de</email>
    </contact>
    <contact_backup>
      <last_name>Ann-Christine Ehlis, PhD</last_name>
      <phone>0049 7071 29</phone>
      <phone_ext>87103</phone_ext>
      <email>Ann-Christine.Ehlis@med.uni-tuebingen.de</email>
    </contact_backup>
    <investigator>
      <last_name>Ann-Christine Ehlis, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 15, 2014</study_first_submitted>
  <study_first_submitted_qc>August 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2014</study_first_posted>
  <last_update_submitted>August 26, 2014</last_update_submitted>
  <last_update_submitted_qc>August 26, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 29, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital Tuebingen</investigator_affiliation>
    <investigator_full_name>Dr. Ann-Christine Ehlis</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alcoholism</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/NCT02228486
org study id: aCR
nct id: NCT02228486
lead sponsor: 
has dmc: No
Relapse is a major risk in substance abuse disorders, which is closely related to craving for
      a substance, describing a strong urge for consumption. Cue-exposure therapy is an
      intervention aiming at the reduction of perceived craving by repeated confrontation. It is
      based on the assumption that craving drops after repeated exposure without the reinforcing
      experience elicited by consumption. In the present study, patients with alcohol dependency
      take part in nine cue-exposure training sessions. Each session consists of mood induction
      reflecting a high risk situation with subsequent in vivo confrontation with one's preferred
      alcoholic beverage followed by the training of coping strategies. During the cue-exposure,
      patients focus on perceiving automatic responses to alcohol-related cues. We hypothesize that
      especially patients exhibiting initially high reactions to such cues should profit from this
      intervention the most. The reactions are measured on a subjective (craving) and physiological
      level (hemodynamics of the prefrontal cortex, heart rate variability, electrodermal
      activity). Furthermore, we want to strengthen the expected training effects during the
      cue-exposure by an activating transcranial direct current stimulation of the dorsolateral
      prefrontal cortex, which has been shown to be hypoactive in substance abuse disorders. We
      investigate how the cue-exposure training affects the processing of alcoholic cues
      (cue-reactivity) and its relation to clinical symptoms of alcohol dependency.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: alcohol consumption days
time frame: six months
measure: Maximum subjective alcohol craving during alcohol cue-exposure (10-point scale)
time frame: 5 weeks
description: During alcohol cue-exposure, subjects rate the subjective craving regularly on a scale from 0 to 10.
measure: subjective rating of self-efficacy (score on a 10 item-scale)
time frame: 6 months
description: questionnaire (General Self-Efficacy Scale, Schwarzer & Jerusalem, 1995)
measure: Hemodynamics in the orbitofrontal cortex and the dorsolateral prefrontal cortex during cue-exposure
time frame: 5 weeks
description: With near-infrared spectroscopy, changes in the concentrations of oxygenated (O2HB) and deoxygenated (HHb) haemoglobin are assessed (in mmol*mm), peaks in those concentrations are evaluated
measure: heart-rate variability during alcohol cue-exposure
time frame: 5 weeks
description: low frequency/ high frequency (LF/HF) power ratio and standard deviation of the duration between R-peaks (RR) during cue-exposure
measure: Skin conductance level during alcohol cue exposure
time frame: 5 weeks
description: skin conductance level (SCL) in Mikrosiemens (μS)
arm group label: Cue Exposure Therapy and verum tDCS
arm group type: Active Comparator
description: During alcohol cue exposure, an active tDCS with a duration of 15 minutes and 2 mA is applied to the left dorsolateral prefrontal cortex (F3, anode) and a reference electrode placed over Fp2 (electrode positions determined by the international 10-20 system). The electrodes are rectangular (35cm2).
arm group label: Cue Exposure Therapy and sham tDCS
arm group type: Placebo Comparator
description: During alcohol cue exposure, a placebo tDCS is used with electrodes placed over the left dorsolateral prefrontal cortex (F3, anode) and a reference electrode placed over Fp2 (electrode positions determined by the international 10-20 system). The electrodes are rectangular (35cm2). There is a 20 second ramp going up until 2 mA and back to 0 again at the beginning and the end of the placebo stimulation with no active stimulation during the cue exposure.
arm group label: Waiting list control group
arm group type: No Intervention
description: The Cue-Reactivity of patients assigned to this arm will be measured twice with an interval of 5 weeks. Afterwards, patients will take part in the cue exposure therapy like subjects assigned to the active arms of the study
intervention type: Device
intervention name: tDCS
description: 2 mA (verum group) over the left dorsolateral prefrontal cortex (F3, anodal), 15 min; 10 seconds ramp in verum and sham group (see also above)
arm group label: Cue Exposure Therapy and verum tDCS
other name: transcrancial direct currenct stimulation
intervention type: Behavioral
intervention name: Cue Exposure Therapy
description: 5 weeks (9 sessions) of cue-exposure therapy with preferred alcoholic beverage (see also above)
arm group label: Cue Exposure Therapy and sham tDCS
arm group label: Cue Exposure Therapy and verum tDCS
other name: Cue-Exposure Training
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ann-Christine Ehlis, PhD
role: Principal Investigator
affiliation: University Hospital Tuebingen
last name: Agnes Kroczek, Dipl.-Psych.
phone: 0049 7071 29
phone ext: 82627
email: Agnes.Kroczek@med.uni-tuebingen.de
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: University Hospital Tuebingen
investigator full name: Dr. Ann-Christine Ehlis
investigator title: Dr.
mesh term: Alcoholism