<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/NCT03287154</url>
  </required_header>
  <id_info>
    <org_study_id>2016-A00304-47</org_study_id>
    <nct_id>NCT03287154</nct_id>
  </id_info>
  <brief_title>Interest of tDCS in Help for Supporting Alcohol Abstinence</brief_title>
  <acronym>ITAMAA</acronym>
  <official_title>Interest of tDCS in Help for Supporting Alcohol Abstinence</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Henri Laborit</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Henri Laborit</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to evaluate in patients with alcohol disorder and forehand weaned the&#xD;
      efficiency of 10 active tDCS sessions versus 10 sham (placebo) sessions in the support of&#xD;
      abstinence at 3 months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study takes place at one site (Henri Laborit Hospital, Poitiers, France) and is&#xD;
      comparative, randomized and controlled.&#xD;
&#xD;
      There are 2 groups : one group is receiving sessions of active tDCS (active group) whereas&#xD;
      the second group is receiving sham (placebo) sessions (control group).&#xD;
&#xD;
      Patients are randomized either in the active group or in the control group with a 1:1 ratio.&#xD;
&#xD;
      An unblinded investigator is responsible of the stimulation part and could not evaluate the&#xD;
      patients. The other investigators are blinded and could evaluate the patients.&#xD;
&#xD;
      The study is going to evaluate the effect produces by stimulations in the two groups.&#xD;
&#xD;
      In the placebo group, after the intensity has reached its maximal intensity (the same as in&#xD;
      the active group), the stimulation is stopped after few seconds (30 seconds in mostly&#xD;
      studies). This process allow patients in the placebo group to feel the same sensations as&#xD;
      patients in the active group (indeed, tingles and itches are felt only during the first few&#xD;
      seconds of stimulation). The poor duration of stimulation do not produces clinical effect.&#xD;
&#xD;
      The study begins after a withdrawal period of 7 days +/- 3 days with 10 stimulations of 2 mA&#xD;
      during 20 minutes from Monday to Friday during 2 weeks.&#xD;
&#xD;
      Following these stimulation sessions, the patient will have 5 follow-up visits on site with&#xD;
      an investigator and 2 phone follow-up.&#xD;
&#xD;
      Visits:&#xD;
&#xD;
        -  Pre-inclusion visit&#xD;
&#xD;
        -  V0 visit (inclusion visit): takes place at the earliest 48 hours after stopping&#xD;
           benzodiazepines used in the withdrawal period.&#xD;
&#xD;
        -  Treatment (weeks 0 and 1): 5 days of treatment per week during 2 weeks 2 arms : sham&#xD;
           (placebo, 10 stimulations) vs active (10 stimulations of 2 mA)&#xD;
&#xD;
        -  Visit 1 (Week 4) : short nurse consultation&#xD;
&#xD;
        -  Visit 2 (Week 6) : short medical consultation&#xD;
&#xD;
        -  Visit 3 (Week 10) : short medical consultation&#xD;
&#xD;
        -  Visit 4 (Week 14) : long medical consultation&#xD;
&#xD;
        -  Visit 5 (Week 18) : nurse phone follow-up&#xD;
&#xD;
        -  Visit 6 (Week 22) : nurse phone follow-up&#xD;
&#xD;
        -  Visit 7 (Week 26) : long medical consultation&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 8, 2017</start_date>
  <completion_date type="Anticipated">November 2024</completion_date>
  <primary_completion_date type="Anticipated">February 2024</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Alcohol Abstinence</measure>
    <time_frame>3 months</time_frame>
    <description>The primary outcome is to evaluate the interest of the transcranial Direct Current Stimulation (tDCS) for helping the abstinence support in addictive alcoholic patients.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Relapse control</measure>
    <time_frame>6 months</time_frame>
    <description>Evaluation of tDCS interest in help for relapse control.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alcohol consumption</measure>
    <time_frame>6 months</time_frame>
    <description>Impact on alcohol consumption based on the Total Alcohol Consumption (TAC).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety-depression</measure>
    <time_frame>6 months</time_frame>
    <description>Impact on the anxiety-depression symptomatology</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tobacco consumption</measure>
    <time_frame>6 months</time_frame>
    <description>Impact on tobacco consumption (decrease of cigarette consumption).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety assessment with adverse and/or intercurrent events analysis.</measure>
    <time_frame>6 months</time_frame>
    <description>The clinical tolerability will be objectified through the analysis of adverse and /or intercurrent events occuring all along the study. Theses events will be assessed at every study visit during patient examination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive functions assessments with the Moca-test questionnaire.</measure>
    <time_frame>6 months</time_frame>
    <description>The score to the Moca-test will permit to assessed the cognitive functions from baseline (week 0) to the week 14 and from baseline from the week 26.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Executive functions assessments with the scale Barratt Impulsiveness Scale (BIS 11).</measure>
    <time_frame>6 months</time_frame>
    <description>This examination will be assessed from week 0 to Day 9, from week 0 to week 14 and from week 0 to week 26.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Executive functions assessments with the Go NoGo task.</measure>
    <time_frame>6 months</time_frame>
    <description>This examination will be assessed from week 0 to Day 9, from week 0 to week 14 and from week 0 to week 26.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Executive functions assessments with the Wisconsin Card Sorting Test (WCST).</measure>
    <time_frame>6 months</time_frame>
    <description>This examination will be assessed from week 0 to Day 9, from week 0 to week 14 and from week 0 to week 26.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Executive functions assessments with the Stroop test.</measure>
    <time_frame>6 months</time_frame>
    <description>This examination will be assessed from week 0 to Day 9, from week 0 to week 14 and from week 0 to week 26.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Executive functions assessments with the IOWA Gambling Task (IGT).</measure>
    <time_frame>6 months</time_frame>
    <description>This examination will be assessed from week 0 to Day 9, from week 0 to week 14 and from week 0 to week 26.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Alcoholic Intoxication</condition>
  <arm_group>
    <arm_group_label>Active tDCS stimulations</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in this arm will receive 10 tDCS active stimulations of 2 mA (1 stimulation per day from Monday to Friday during 2 weeks).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham tDCS</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Patients in this arm will receive 10 sham stimulations (1 stimulation per day from Monday to Friday during 2 weeks).&#xD;
As soon as the power will have reached the maximal intensity as in the active arm, the stimulation will be stopped.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Active tDCS stimulations</intervention_name>
    <description>20 min, 2mA</description>
    <arm_group_label>Active tDCS stimulations</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham tDCS</intervention_name>
    <description>20 min, Sham</description>
    <arm_group_label>Sham tDCS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patient aged from 18 to 70 years old&#xD;
&#xD;
          -  patient free, without guardianship&#xD;
&#xD;
          -  absence of epileptic pathology&#xD;
&#xD;
          -  patient affiliated to the french health security or benefiting through a third party&#xD;
&#xD;
          -  signed informed consent after having received a clear and honest information on the&#xD;
             study.&#xD;
&#xD;
          -  patient with a disorder linked to the use of alcohol (define by the Diagnostic and&#xD;
             Statistical Manual of Mental Disorders (DSM-5) classification) clinically evaluated.&#xD;
&#xD;
          -  patient requesting for an alcohol withdrawal&#xD;
&#xD;
          -  patient able to read and write&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patient not affiliated to the french health security or not benefiting through a third&#xD;
             party&#xD;
&#xD;
          -  woman in reproductive capacity without effective contraception (hormonal/mechanical:&#xD;
             per os, injectable, transcutaneous, implantable, intra-uterine device or chirurgical:&#xD;
             tubal ligation, hysterectomy, total ovariectomy) or breastfeeding&#xD;
&#xD;
          -  patient hospitalized under duress&#xD;
&#xD;
          -  patient with guardianship&#xD;
&#xD;
          -  somatic complications during the alcohol withdrawal phase&#xD;
&#xD;
          -  current psychiatric decompensation (mood disorder, suicide risk, psychotic disorders).&#xD;
&#xD;
          -  patient under benzodiazepines treatment&#xD;
&#xD;
          -  patient with scalp cutaneous lesion&#xD;
&#xD;
          -  history of cranial traumatism&#xD;
&#xD;
          -  patient with intra-cerebral metallic object&#xD;
&#xD;
          -  patient with a pacemaker&#xD;
&#xD;
          -  epileptic pathology&#xD;
&#xD;
          -  patient in emergency condition or unable to give personally her/his consent&#xD;
&#xD;
          -  another dependence other than alcohol or tobacco&#xD;
&#xD;
          -  mental illness syndrome and Korsakoff&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nematollah Jaafari, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Hospitalier Henri Laborit</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nematollah Jaafari, Professor</last_name>
    <phone>0033 5 16 52 61 18</phone>
    <email>nemat.jaafari@ch-poitiers.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Centre Hospitalier Henri Laborit</name>
      <address>
        <city>Poitiers</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nematollah Jaafari, Professor</last_name>
      <phone>0033 5 16 52 61 18</phone>
      <email>nemat.jaafari@ch-poitiers.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Nord-Deux-Sèvres</name>
      <address>
        <city>Thouars</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Issa Wassouf, Doctor</last_name>
      <email>wassouf.issa@chnds.fr</email>
    </contact>
    <investigator>
      <last_name>Issa Wassouf, Doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>September 7, 2017</study_first_submitted>
  <study_first_submitted_qc>September 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 19, 2017</study_first_posted>
  <last_update_submitted>August 2, 2023</last_update_submitted>
  <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Alcohol Abstinence</keyword>
  <keyword>Alcohol Addiction</keyword>
  <keyword>Alcohol Consumption</keyword>
  <keyword>Alcohol Dependence</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alcoholic Intoxication</mesh_term>
    <mesh_term>Alcohol Abstinence</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03287154
org study id: 2016-A00304-47
nct id: NCT03287154
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to evaluate in patients with alcohol disorder and forehand weaned the
      efficiency of 10 active tDCS sessions versus 10 sham (placebo) sessions in the support of
      abstinence at 3 months.
The study takes place at one site (Henri Laborit Hospital, Poitiers, France) and is
      comparative, randomized and controlled.

      There are 2 groups : one group is receiving sessions of active tDCS (active group) whereas
      the second group is receiving sham (placebo) sessions (control group).

      Patients are randomized either in the active group or in the control group with a 1:1 ratio.

      An unblinded investigator is responsible of the stimulation part and could not evaluate the
      patients. The other investigators are blinded and could evaluate the patients.

      The study is going to evaluate the effect produces by stimulations in the two groups.

      In the placebo group, after the intensity has reached its maximal intensity (the same as in
      the active group), the stimulation is stopped after few seconds (30 seconds in mostly
      studies). This process allow patients in the placebo group to feel the same sensations as
      patients in the active group (indeed, tingles and itches are felt only during the first few
      seconds of stimulation). The poor duration of stimulation do not produces clinical effect.

      The study begins after a withdrawal period of 7 days +/- 3 days with 10 stimulations of 2 mA
      during 20 minutes from Monday to Friday during 2 weeks.

      Following these stimulation sessions, the patient will have 5 follow-up visits on site with
      an investigator and 2 phone follow-up.

      Visits:

        -  Pre-inclusion visit

        -  V0 visit (inclusion visit): takes place at the earliest 48 hours after stopping
           benzodiazepines used in the withdrawal period.

        -  Treatment (weeks 0 and 1): 5 days of treatment per week during 2 weeks 2 arms : sham
           (placebo, 10 stimulations) vs active (10 stimulations of 2 mA)

        -  Visit 1 (Week 4) : short nurse consultation

        -  Visit 2 (Week 6) : short medical consultation

        -  Visit 3 (Week 10) : short medical consultation

        -  Visit 4 (Week 14) : long medical consultation

        -  Visit 5 (Week 18) : nurse phone follow-up

        -  Visit 6 (Week 22) : nurse phone follow-up

        -  Visit 7 (Week 26) : long medical consultation
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Alcohol Abstinence
time frame: 3 months
description: The primary outcome is to evaluate the interest of the transcranial Direct Current Stimulation (tDCS) for helping the abstinence support in addictive alcoholic patients.
measure: Relapse control
time frame: 6 months
description: Evaluation of tDCS interest in help for relapse control.
measure: Alcohol consumption
time frame: 6 months
description: Impact on alcohol consumption based on the Total Alcohol Consumption (TAC).
measure: Anxiety-depression
time frame: 6 months
description: Impact on the anxiety-depression symptomatology
measure: Tobacco consumption
time frame: 6 months
description: Impact on tobacco consumption (decrease of cigarette consumption).
measure: Safety assessment with adverse and/or intercurrent events analysis.
time frame: 6 months
description: The clinical tolerability will be objectified through the analysis of adverse and /or intercurrent events occuring all along the study. Theses events will be assessed at every study visit during patient examination.
measure: Cognitive functions assessments with the Moca-test questionnaire.
time frame: 6 months
description: The score to the Moca-test will permit to assessed the cognitive functions from baseline (week 0) to the week 14 and from baseline from the week 26.
measure: Executive functions assessments with the scale Barratt Impulsiveness Scale (BIS 11).
time frame: 6 months
description: This examination will be assessed from week 0 to Day 9, from week 0 to week 14 and from week 0 to week 26.
measure: Executive functions assessments with the Go NoGo task.
time frame: 6 months
description: This examination will be assessed from week 0 to Day 9, from week 0 to week 14 and from week 0 to week 26.
measure: Executive functions assessments with the Wisconsin Card Sorting Test (WCST).
time frame: 6 months
description: This examination will be assessed from week 0 to Day 9, from week 0 to week 14 and from week 0 to week 26.
measure: Executive functions assessments with the Stroop test.
time frame: 6 months
description: This examination will be assessed from week 0 to Day 9, from week 0 to week 14 and from week 0 to week 26.
measure: Executive functions assessments with the IOWA Gambling Task (IGT).
time frame: 6 months
description: This examination will be assessed from week 0 to Day 9, from week 0 to week 14 and from week 0 to week 26.
arm group label: Active tDCS stimulations
arm group type: Experimental
description: Patients in this arm will receive 10 tDCS active stimulations of 2 mA (1 stimulation per day from Monday to Friday during 2 weeks).
arm group label: Sham tDCS
arm group type: Sham Comparator
description: Patients in this arm will receive 10 sham stimulations (1 stimulation per day from Monday to Friday during 2 weeks).
As soon as the power will have reached the maximal intensity as in the active arm, the stimulation will be stopped.
intervention type: Device
intervention name: Active tDCS stimulations
description: 20 min, 2mA
arm group label: Active tDCS stimulations
intervention type: Device
intervention name: Sham tDCS
description: 20 min, Sham
arm group label: Sham tDCS
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Nematollah Jaafari, Professor
role: Principal Investigator
affiliation: Centre Hospitalier Henri Laborit
last name: Nematollah Jaafari, Professor
phone: 0033 5 16 52 61 18
email: nemat.jaafari@ch-poitiers.fr
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Alcoholic Intoxication
mesh term: Alcohol Abstinence
sharing ipd: No