<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/NCT01679145</url>
  </required_header>
  <id_info>
    <org_study_id>HE2597/141;ZI1119/31;WI709/101</org_study_id>
    <nct_id>NCT01679145</nct_id>
  </id_info>
  <brief_title>Learning and Relapse Risk in Alcohol Dependence</brief_title>
  <acronym>LeAD</acronym>
  <official_title>Learning Mechanisms as Predictors of Treatment Outcome in Alcohol- Dependent Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Technische Universität Dresden</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Charite University, Berlin, Germany</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital Carl Gustav Carus</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Technische Universität Dresden</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this project is to assess which behavioral and neuroimaging alterations associated&#xD;
      with reward- based learning predict relapse in alcohol- dependent patients within a follow-&#xD;
      up period of 12 months.&#xD;
&#xD;
      The investigators will explore how these alterations interact with clinical and psychosocial&#xD;
      factors which can modify the relapse risk. Functional magnetic resonance imaging (fMRI) and&#xD;
      positron emission tomography (PET) will be used to identify neurofunctional abnormalities in&#xD;
      neurotransmitter systems. The investigators will also provide data for genetic analysis and&#xD;
      modeling.&#xD;
&#xD;
      Patients will be detoxified in an inpatient setting and followed for 12 months using the&#xD;
      Time-Line Follow- Back Procedure. Clinical assessments, behavioral paradigms of learning and&#xD;
      brain imaging will be carried out within at least 4 half- lives after any psychotropic&#xD;
      medication.&#xD;
&#xD;
      The investigators will implement and apply functional imaging paradigms assessing&#xD;
      Pavlovian-to-instrumental transfer and reversal learning tasks and associate model parameters&#xD;
      of learning with alcohol craving, intake and prospective relapse risk.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This project will examine 150 detoxified alcohol-dependent patients and 100 age- and gender&#xD;
      matched controls. The main aim of this project is to assess 1) which behavioural and&#xD;
      neuroimaging alterations (fMRI) associated with reward-based learning (see Projects 1 &amp; 3)&#xD;
      predict relapse within the follow-up period of 6 months, 2) how these interact with clinical&#xD;
      and psychosocial factors which can modify the relapse risk, and 3) to provide data for&#xD;
      genetic and imaging analyses and modelling. Furthermore, we will explore gender effects on&#xD;
      functional imaging parameters of learning. Patients will be detoxified in an inpatient&#xD;
      setting and followed for 6 months using the Form 90 and Time-Line Follow-Back Procedure.&#xD;
      Clinical assessments, behavioral paradigms of learning, and brain imaging will be carried out&#xD;
      within at least 4 half-lives after any psychotropic medication. Subjects will undergo medical&#xD;
      management with bimonthly follow-ups and predefined in- and exclusion criteria as described&#xD;
      previously. We will implement and apply functional imaging paradigms assessing&#xD;
      Pavlovian-to-instrumental transfer and reversal learning as described in Projects 1 and 3. We&#xD;
      will associate model parameters of learning with alcohol craving, intake and prospective&#xD;
      relapse risk. Independent of these central questions, we will also assess comorbidity,&#xD;
      psychosocial and neurobiological disease severity markers to control for specificity of&#xD;
      findings.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>blood oxygenation level dependent (BOLD) response</measure>
    <time_frame>first assessment time point (alc. dependent pat. up to 21 days after detoxification)</time_frame>
    <description>investigation of neuronal activation of the mesolimbic system in alcohol-dependent patients and healthy controls using 3 Tesla magnetic resonance imaging</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Treatment response</measure>
    <time_frame>12-month follow-up period beginning after first assessment timepoint</time_frame>
    <description>test the predictive effects of learning parameters and related neuronal correlates for treatment outcome (relapse vs abstinence) in alcohol-dependent patients</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">225</enrollment>
  <condition>Alcohol Use Disorders</condition>
  <arm_group>
    <arm_group_label>Alcohol- dependent patients</arm_group_label>
    <description>Detoxified alcohol- dependent patients in an inpatient setting</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <description>Age- and gender matched healthy controls</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      liver encymes&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Detoxified alcohol- dependent patients and age- and gender matched healthy controls living&#xD;
        in Germany&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Alcohol dependence according to DSM-IV&#xD;
&#xD;
          -  Minimum of 72 hours of abstinence, maximum of 21 days of abstinence&#xD;
&#xD;
          -  Minimum of three years of alcohol dependence&#xD;
&#xD;
          -  Low severity of withdrawal symptoms&#xD;
&#xD;
          -  Ability to provide fully informed consent and to use self- rating scales&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Lifetime history of DSM- IV bipolar or psychotic disorder&#xD;
&#xD;
          -  Current threshold DSM-IV diagnosis of any following disorders: current major -&#xD;
             depressive disorder, generalized anxiety disorder, PTSD, borderline personality&#xD;
             disorder or obsessive- compulsive disorder&#xD;
&#xD;
          -  History of substance dependence other than alcohol or nicotine dependence&#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>Andreas Heinz, Prof MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Charite University, Berlin, Germany</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ulrich S Zimmermann, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Carl Gustav Carus, Dresden, Germany</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Andreas Heinz, Prof MD</last_name>
    <role>Study Chair</role>
    <affiliation>Charité University, Berlin, Germany</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hans-Ulrich Wittchen, Prof PhD</last_name>
    <role>Study Director</role>
    <affiliation>Technische Universität Dresden, Dresden, Germany</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Technische Universität Dresden</name>
      <address>
        <city>Dresden</city>
        <state>Saxony</state>
        <zip>01187</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Carl Gustav Carus at the Technische Universitaet Dresden</name>
      <address>
        <city>Dresden</city>
        <state>Saxony</state>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charité - Universitätsmedizin Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <link>
    <url>http://lead-studie.de/</url>
    <description>Official study group website</description>
  </link>
  <link>
    <url>http://gepris.dfg.de/gepris/projekt/209290463</url>
    <description>English study description</description>
  </link>
  <verification_date>July 2016</verification_date>
  <study_first_submitted>August 31, 2012</study_first_submitted>
  <study_first_submitted_qc>September 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2012</study_first_posted>
  <last_update_submitted>July 27, 2016</last_update_submitted>
  <last_update_submitted_qc>July 27, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 28, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Reward- based learning</keyword>
  <keyword>Pavlovian-to-instrumental transfer</keyword>
  <keyword>Functional imaging</keyword>
  <keyword>Relapse risk</keyword>
  <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/NCT01679145
org study id: HE2597/141;ZI1119/31;WI709/101
nct id: NCT01679145
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The aim of this project is to assess which behavioral and neuroimaging alterations associated
      with reward- based learning predict relapse in alcohol- dependent patients within a follow-
      up period of 12 months.

      The investigators will explore how these alterations interact with clinical and psychosocial
      factors which can modify the relapse risk. Functional magnetic resonance imaging (fMRI) and
      positron emission tomography (PET) will be used to identify neurofunctional abnormalities in
      neurotransmitter systems. The investigators will also provide data for genetic analysis and
      modeling.

      Patients will be detoxified in an inpatient setting and followed for 12 months using the
      Time-Line Follow- Back Procedure. Clinical assessments, behavioral paradigms of learning and
      brain imaging will be carried out within at least 4 half- lives after any psychotropic
      medication.

      The investigators will implement and apply functional imaging paradigms assessing
      Pavlovian-to-instrumental transfer and reversal learning tasks and associate model parameters
      of learning with alcohol craving, intake and prospective relapse risk.
This project will examine 150 detoxified alcohol-dependent patients and 100 age- and gender
      matched controls. The main aim of this project is to assess 1) which behavioural and
      neuroimaging alterations (fMRI) associated with reward-based learning (see Projects 1 & 3)
      predict relapse within the follow-up period of 6 months, 2) how these interact with clinical
      and psychosocial factors which can modify the relapse risk, and 3) to provide data for
      genetic and imaging analyses and modelling. Furthermore, we will explore gender effects on
      functional imaging parameters of learning. Patients will be detoxified in an inpatient
      setting and followed for 6 months using the Form 90 and Time-Line Follow-Back Procedure.
      Clinical assessments, behavioral paradigms of learning, and brain imaging will be carried out
      within at least 4 half-lives after any psychotropic medication. Subjects will undergo medical
      management with bimonthly follow-ups and predefined in- and exclusion criteria as described
      previously. We will implement and apply functional imaging paradigms assessing
      Pavlovian-to-instrumental transfer and reversal learning as described in Projects 1 and 3. We
      will associate model parameters of learning with alcohol craving, intake and prospective
      relapse risk. Independent of these central questions, we will also assess comorbidity,
      psychosocial and neurobiological disease severity markers to control for specificity of
      findings.
observational model: Case-Control
time perspective: Prospective
measure: blood oxygenation level dependent (BOLD) response
time frame: first assessment time point (alc. dependent pat. up to 21 days after detoxification)
description: investigation of neuronal activation of the mesolimbic system in alcohol-dependent patients and healthy controls using 3 Tesla magnetic resonance imaging
measure: Treatment response
time frame: 12-month follow-up period beginning after first assessment timepoint
description: test the predictive effects of learning parameters and related neuronal correlates for treatment outcome (relapse vs abstinence) in alcohol-dependent patients
arm group label: Alcohol- dependent patients
description: Detoxified alcohol- dependent patients in an inpatient setting
arm group label: Control group
description: Age- and gender matched healthy controls
liver encymes
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: Andreas Heinz, Prof MD
role: Principal Investigator
affiliation: Charite University, Berlin, Germany
last name: Ulrich S Zimmermann, MD
role: Principal Investigator
affiliation: University Hospital Carl Gustav Carus, Dresden, Germany
last name: Andreas Heinz, Prof MD
role: Study Chair
affiliation: Charité University, Berlin, Germany
last name: Hans-Ulrich Wittchen, Prof PhD
role: Study Director
affiliation: Technische Universität Dresden, Dresden, Germany
facility: 
facility: 
facility: 
country: Germany
url: http://lead-studie.de/
description: Official study group website
url: http://gepris.dfg.de/gepris/projekt/209290463
description: English study description
responsible party type: Sponsor
mesh term: Alcoholism