<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/NCT01729507</url>
  </required_header>
  <id_info>
    <org_study_id>489-11</org_study_id>
    <nct_id>NCT01729507</nct_id>
  </id_info>
  <brief_title>tDCS as Add on Therapy for Treatment of Tobacco Dependence by Standardized Behaviour Therapy</brief_title>
  <official_title>Transcranial Direct Current Stimulation (TDCS) as Add on Therapy for Treatment of Tobacco Dependence by Standardized Behaviour Therapy - Active and Placebo Controlled Double Blind Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ludwig-Maximilians - University of Munich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ludwig-Maximilians - University of Munich</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      As an add-on treatment to behavioural therapy for tobacco dependence, anodal transcranial&#xD;
      direct current stimulation (tDCS) significantly increases the cessation rate compared to&#xD;
      treatment with sham tDCS; endpoint analysis will be performed 1, 3, 6 and 12 months after&#xD;
      completion of the smoke-free programme in combination with tDCS.&#xD;
&#xD;
      Craving, assessed with a visual analog scale (VAS), is reduced significantly in the verum&#xD;
      treatment group compared to the sham tDCS group.&#xD;
&#xD;
      tDCS is suitable for use in larger groups (8-12 people).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. General design and study population&#xD;
&#xD;
           Controlled, randomised, double-blind study with no crossover; sample size estimate:&#xD;
           20-36 participants.&#xD;
&#xD;
           Sample size calculations are not necessary for pilot studies. A general 'rule of thumb'&#xD;
           is to use 30 or more patients.&#xD;
&#xD;
           An interim analysis of the data will be performed after completion of the second course&#xD;
           (stimulation of 24 patients). We reserve the right to increase the sample size by 12-24,&#xD;
           depending on the effect size, so that we have data from 30 participants per arm and the&#xD;
           estimate is reliable.&#xD;
&#xD;
           Study participants will be recruited via newspaper advertisements, advertisements on the&#xD;
           internet page of the tobacco outpatient clinic and announcements on notice boards in the&#xD;
           Department of Psychiatry.&#xD;
&#xD;
           Study duration: it is estimated that 12 days will be required for each patient to&#xD;
           complete the study protocol. The total study duration for 36 patients is estimated to be&#xD;
           12 months.&#xD;
&#xD;
        2. Screening&#xD;
&#xD;
           No screening investigations will be performed.&#xD;
&#xD;
        3. Randomisation and blinding&#xD;
&#xD;
           Patients will be randomised to two groups of 10-18 patients each. One group will receive&#xD;
           7x verum treatment with tDSC, the other 7x sham treatment. All participants will then&#xD;
           receive standardised behavioural therapy ('The smoke-free programme'). Both patients and&#xD;
           clinical raters will be blind to the treatment condition. Unblinding will take place&#xD;
           only after completion of the study or if the whole study is discontinued because of&#xD;
           severe incidents.&#xD;
&#xD;
        4. Experimental paradigm&#xD;
&#xD;
           Up to 12 participants (maximum number of participants for the smoke-free programme) will&#xD;
           be stimulated per course. A total of 3x12 participants will be stimulated during the&#xD;
           study and subsequently participate in the certified behavioural therapy 'Smoke-free&#xD;
           programme' by Gradl, S. and Kröger, C. (2008).&#xD;
&#xD;
           Blinding will be performed before the start of the study. Every participant will be&#xD;
           given a number (pseudonym), which will be programmed into the stimulator. Each number&#xD;
           will be randomly assigned to sham or verum treatment and the same treatment will then be&#xD;
           performed at every session. The stimulator can be programmed beforehand to assign&#xD;
           numbers randomly to the verum or sham group, so that the respective patient data are&#xD;
           unknown to both the person who performs the stimulation and the course leaders. Half of&#xD;
           the participants will be randomly assigned to the sham group and half to the verum&#xD;
           group. The stimulator will be programmed at the start of the study.&#xD;
&#xD;
           Stimulation will be performed with a DC stimulator MC (neuroConn GmbH, Ilmenau,&#xD;
           Germany). The stimulator is a micro-processor-controlled constant current source with up&#xD;
           to 16 freely programmable independent channels. The maximum current strength is 5 mA and&#xD;
           the maximum stimulation duration 30 minutes. The stimulator is a CE-certified medical&#xD;
           product that has been used in various national and international studies.&#xD;
&#xD;
           The current is transmitted via sponge electrodes (35 cm2) soaked in physiological salt&#xD;
           solution. The electrodes are attached to the head with elasticated bands.&#xD;
&#xD;
           Location of stimulation: Anode over the left dorsolateral cortex, corresponding with F3&#xD;
           (in 10-20 EEG system); cathode over the right temporal cortex; Intensity: 2 mA; Total&#xD;
           duration: Constant stimulation for 20 minutes, plus 15 seconds ramp-in and ramp-out&#xD;
           phase during which the current will be regulated up and down, respectively.&#xD;
&#xD;
           Stimulation time schedule: Each participant will be stimulated a total of 7 times over 7&#xD;
           weeks.&#xD;
&#xD;
           The stimulation will be followed by a 90-minute session of the 'Smoke-free programme'.&#xD;
&#xD;
           The standardised behavioural therapy will be performed according to the certified&#xD;
           &quot;Smoke-free programme' of the of the Institute for Therapy Research ('Institut für&#xD;
           Therapieforschung', IFT). The course leaders' manual specifies that the ideal number of&#xD;
           participants is 8-12.&#xD;
&#xD;
           IFT 6-week course&#xD;
&#xD;
           Schedule:&#xD;
&#xD;
           Duration: 7 weeks 1 group session for 90 minutes/week for 7 weeks 2 telephone calls of&#xD;
           10 minutes each, first after the fourth session 3 days after collective smoking&#xD;
           cessation, second on day 3 after the last session.&#xD;
&#xD;
           Study procedures:&#xD;
&#xD;
             -  1st session: Smoking and a smoke-free life&#xD;
&#xD;
             -  2nd session: The smoker's ambivalence&#xD;
&#xD;
             -  3rd session: Errors in reasoning and alternatives&#xD;
&#xD;
             -  4th session: Preparing to quit smoking&#xD;
&#xD;
           SMOKING CESSATION&#xD;
&#xD;
             -  1st telephone call: Individual telephone support&#xD;
&#xD;
             -  5th session: Experiences from quitting smoking&#xD;
&#xD;
             -  6th session: Identity as a smoke-free person&#xD;
&#xD;
             -  7th session: Planning the future&#xD;
&#xD;
             -  2nd telephone call: Individual telephone support&#xD;
&#xD;
        5. Evaluation scales&#xD;
&#xD;
             -  Edinburgh Handedness Test: Test to assess left- or right-handedness to evaluate the&#xD;
                dominant hemisphere.&#xD;
&#xD;
             -  Comfort Rating Questionnaire: Questionnaire to record symptoms after tDCS&#xD;
&#xD;
             -  Fagerström Test: Questionnaire to evaluate physical tobacco dependence&#xD;
&#xD;
             -  Questionnaire on Smoking Urges (Tiffany &amp; Drobes, 1991) (German version: Müller,&#xD;
                Mucha, Ackermann &amp; Pauli, 2001): Uses two scales to measure craving for cigarettes.&#xD;
&#xD;
        6. Additional evaluations&#xD;
&#xD;
           As an additional evaluation, at the start of the stimulation and at four follow-up&#xD;
           appointments salivary cotinine (a degradation product of tobacco) and the carbon&#xD;
           monoxide content of expired air will be measured. Carbon monoxide will be measured with&#xD;
           a Micro Smokerlyzer (Bedfont Scientific Ltd., Maidstone, England).&#xD;
&#xD;
           At the end of each tDCS treatment, the study participants will complete a Comfort Rating&#xD;
           Questionnaire (CRQ). Our research group has used this questionnaire about direct current&#xD;
           stimulation for several years and has continually improved and updated it. The&#xD;
           questionnaire records unpleasant sensations and side effects during and after direct&#xD;
           current stimulation.&#xD;
&#xD;
        7. Sample size estimate&#xD;
&#xD;
           Sample size estimation and study design correspond with the usual procedures in&#xD;
           comparable pilot studies (e.g. on tDCS or TMS).&#xD;
&#xD;
        8. Statistical analysis&#xD;
&#xD;
      Data will be analysed with a multivariate analysis of covariance (MANCOVA). The absolute&#xD;
      values of the evaluation scales will be the dependent variables and the treatment condition&#xD;
      the independent factor.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2012</start_date>
  <completion_date type="Anticipated">July 2013</completion_date>
  <primary_completion_date type="Anticipated">July 2013</primary_completion_date>
  <phase>Phase 4</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>cessation rate</measure>
    <time_frame>at 4 weeks after last intervention</time_frame>
    <description>salivary cotinine in ng/ml and the carbon monoxide content of expired air (COppm and %COHb)will be measured.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Craving</measure>
    <time_frame>week one directly before first tDCS intervention</time_frame>
    <description>Craving, assessed with a visual analog scale (VAS)and Questionnaire on Smoking Urges (QSU), is reduced significantly in the verum treatment group compared to the sham tDCS group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Craving</measure>
    <time_frame>week two directly before second tDCS intervention</time_frame>
    <description>Craving, assessed with a visual analog scale (VAS)and Questionnaire on Smoking Urges (QSU), is reduced significantly in the verum treatment group compared to the sham tDCS group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Craving</measure>
    <time_frame>week three directly before third tDCS intervention</time_frame>
    <description>Craving, assessed with a visual analog scale (VAS)and Questionnaire on Smoking Urges (QSU), is reduced significantly in the verum treatment group compared to the sham tDCS group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Craving</measure>
    <time_frame>week four directly before fourth tDCS intervention</time_frame>
    <description>Craving, assessed with a visual analog scale (VAS)and Questionnaire on Smoking Urges (QSU), is reduced significantly in the verum treatment group compared to the sham tDCS group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Craving</measure>
    <time_frame>week five directly before fifth tDCS intervention</time_frame>
    <description>Craving, assessed with a visual analog scale (VAS)and Questionnaire on Smoking Urges (QSU), is reduced significantly in the verum treatment group compared to the sham tDCS group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Craving</measure>
    <time_frame>week six directly before sixth tDCS intervention</time_frame>
    <description>Craving, assessed with a visual analog scale (VAS)and Questionnaire on Smoking Urges (QSU), is reduced significantly in the verum treatment group compared to the sham tDCS group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Craving</measure>
    <time_frame>week seven directly before seventh tDCS intervention</time_frame>
    <description>Craving, assessed with a visual analog scale (VAS)and Questionnaire on Smoking Urges (QSU), is reduced significantly in the verum treatment group compared to the sham tDCS group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Craving</measure>
    <time_frame>four weeks after last intervention</time_frame>
    <description>Craving, assessed with a visual analog scale (VAS)and Questionnaire on Smoking Urges (QSU), is reduced significantly in the verum treatment group compared to the sham tDCS group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Craving</measure>
    <time_frame>twelve weeks after last intervention</time_frame>
    <description>Craving, assessed with a visual analog scale (VAS)and Questionnaire on Smoking Urges (QSU), is reduced significantly in the verum treatment group compared to the sham tDCS group.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>cessation rate</measure>
    <time_frame>at 12 weeks after last intervention</time_frame>
    <description>salivary cotinine in ng/ml and the carbon monoxide content of expired air (COppm and %COHb)will be measured.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Smoking Cessation</condition>
  <condition>Tobacco Dependence</condition>
  <arm_group>
    <arm_group_label>Treatment with tDCS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group will receive 7x verum treatment with tDSC. All participants receive standardised behavioural therapy ('The smoke-free programme')</description>
  </arm_group>
  <arm_group>
    <arm_group_label>7x sham treatment</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>This group will receive 7x sham treatment. All participants will receive standardised behavioural therapy ('The smoke-free programme')</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>tDCS</intervention_name>
    <description>Stimulation will be performed with a DC stimulator MC Location of stimulation: Anode over the left dorsolateral cortex, corresponding with F3 (in 10-20 EEG system); cathode over the right temporal cortex Intensity: 2 mA Total duration: Constant stimulation for 20 minutes</description>
    <arm_group_label>Treatment with tDCS</arm_group_label>
    <other_name>Stimulator MC (neuroConn GmbH, Ilmenau, Germany).</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>standardised behavioural therapy</intervention_name>
    <description>The standardised behavioural therapy will be performed according to the certified &quot;Smoke-free programme' of the of the Institute for Therapy Research ('Institut für Therapieforschung', IFT). The course leaders' manual specifies that the ideal number of participants is 8-12.&#xD;
1 group session for 90 minutes/week for 7 weeks, 2 telephone calls of 10 minutes each, first after the fourth session 3 days after collective smoking cessation, second on day 3 after the last session.</description>
    <arm_group_label>7x sham treatment</arm_group_label>
    <arm_group_label>Treatment with tDCS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Age of legal majority&#xD;
&#xD;
          -  Smoker for &gt; 1 year, &gt;10 cigarettes/day&#xD;
&#xD;
          -  CO&gt;10ppm; measurement in expired air by means of a Micro Smokerlyzer (Bedfont&#xD;
             Scientific Ltd., Maidstone, England)&#xD;
&#xD;
          -  Quantification of tobacco dependence with the Fagerström Test&#xD;
&#xD;
          -  The patient should not have attempted to quit smoking or have received drug treatment&#xD;
             for quitting smoking for at least 3 months before the start of the study&#xD;
&#xD;
          -  Ability to give informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute psychiatric disorders according to ISD-10/DSM-IV&#xD;
&#xD;
          -  Under legal care&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Contraceptive methods with a Pearl Index &gt;1&#xD;
&#xD;
          -  Other severe psychiatric disorders&#xD;
&#xD;
          -  Acute suicidality&#xD;
&#xD;
          -  Drug, medication or alcohol abuse at the time of the study&#xD;
&#xD;
          -  Dementia (DSM-IV/ICD-10 criteria)&#xD;
&#xD;
          -  History of severe craniocerebral trauma&#xD;
&#xD;
          -  Indications of structural damage to the basal ganglia or the brain stem&#xD;
&#xD;
          -  Severe neurological disorders (such as prolapsed disk in the past 6 months,&#xD;
             polyneuropathy, Parkinson syndrome, epilepsy, dementia, systemic neurological&#xD;
             diseases, cerebrovascular diseases, history of stroke, repeated cerebral ischaemia&#xD;
             with progressive worsening, elevated cerebral pressure, normal pressure hydrocephalus)&#xD;
&#xD;
          -  Severe medical disorders (such as manifest arterial hypertension, severe&#xD;
             cardiovascular disorders, cardiac pacemaker, respiratory insufficiency)&#xD;
&#xD;
          -  Any electronic implants&#xD;
&#xD;
          -  Malignant diseases of any kind, also in the medical history&#xD;
&#xD;
          -  Severe active infectious diseases&#xD;
&#xD;
          -  Chronic and systemic skin diseases&#xD;
&#xD;
          -  Bone diseases (such as Paget's disease, osteoporosis with spontaneous fractures, fresh&#xD;
             fractures)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Frank Padberg, PD Dr.</last_name>
    <role>Study Director</role>
    <affiliation>Department of Psychotherapy and Psychosomatic Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ludwig Maximilans University</name>
      <address>
        <city>Munich</city>
        <state>Bavaria</state>
        <zip>80336</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andrea Linhardt</last_name>
      <phone>00498951605707</phone>
      <email>andrea.linhardt@med.uni-muenchen.de</email>
    </contact>
    <investigator>
      <last_name>Andrea Linhardt</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>May 28, 2012</study_first_submitted>
  <study_first_submitted_qc>November 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 20, 2012</study_first_posted>
  <last_update_submitted>November 25, 2012</last_update_submitted>
  <last_update_submitted_qc>November 25, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 27, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ludwig-Maximilians - University of Munich</investigator_affiliation>
    <investigator_full_name>Andrea Linhardt</investigator_full_name>
    <investigator_title>physician</investigator_title>
  </responsible_party>
  <keyword>Smoking cessation</keyword>
  <keyword>Add on and smoking cessation</keyword>
  <keyword>Therapy for tobacco dependence</keyword>
  <keyword>Transcranial direct current stimulation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tobacco Use Disorder</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/NCT01729507
org study id: 489-11
nct id: NCT01729507
lead sponsor: 
has dmc: No
As an add-on treatment to behavioural therapy for tobacco dependence, anodal transcranial
      direct current stimulation (tDCS) significantly increases the cessation rate compared to
      treatment with sham tDCS; endpoint analysis will be performed 1, 3, 6 and 12 months after
      completion of the smoke-free programme in combination with tDCS.

      Craving, assessed with a visual analog scale (VAS), is reduced significantly in the verum
      treatment group compared to the sham tDCS group.

      tDCS is suitable for use in larger groups (8-12 people).
1. General design and study population

           Controlled, randomised, double-blind study with no crossover; sample size estimate:
           20-36 participants.

           Sample size calculations are not necessary for pilot studies. A general 'rule of thumb'
           is to use 30 or more patients.

           An interim analysis of the data will be performed after completion of the second course
           (stimulation of 24 patients). We reserve the right to increase the sample size by 12-24,
           depending on the effect size, so that we have data from 30 participants per arm and the
           estimate is reliable.

           Study participants will be recruited via newspaper advertisements, advertisements on the
           internet page of the tobacco outpatient clinic and announcements on notice boards in the
           Department of Psychiatry.

           Study duration: it is estimated that 12 days will be required for each patient to
           complete the study protocol. The total study duration for 36 patients is estimated to be
           12 months.

        2. Screening

           No screening investigations will be performed.

        3. Randomisation and blinding

           Patients will be randomised to two groups of 10-18 patients each. One group will receive
           7x verum treatment with tDSC, the other 7x sham treatment. All participants will then
           receive standardised behavioural therapy ('The smoke-free programme'). Both patients and
           clinical raters will be blind to the treatment condition. Unblinding will take place
           only after completion of the study or if the whole study is discontinued because of
           severe incidents.

        4. Experimental paradigm

           Up to 12 participants (maximum number of participants for the smoke-free programme) will
           be stimulated per course. A total of 3x12 participants will be stimulated during the
           study and subsequently participate in the certified behavioural therapy 'Smoke-free
           programme' by Gradl, S. and Kröger, C. (2008).

           Blinding will be performed before the start of the study. Every participant will be
           given a number (pseudonym), which will be programmed into the stimulator. Each number
           will be randomly assigned to sham or verum treatment and the same treatment will then be
           performed at every session. The stimulator can be programmed beforehand to assign
           numbers randomly to the verum or sham group, so that the respective patient data are
           unknown to both the person who performs the stimulation and the course leaders. Half of
           the participants will be randomly assigned to the sham group and half to the verum
           group. The stimulator will be programmed at the start of the study.

           Stimulation will be performed with a DC stimulator MC (neuroConn GmbH, Ilmenau,
           Germany). The stimulator is a micro-processor-controlled constant current source with up
           to 16 freely programmable independent channels. The maximum current strength is 5 mA and
           the maximum stimulation duration 30 minutes. The stimulator is a CE-certified medical
           product that has been used in various national and international studies.

           The current is transmitted via sponge electrodes (35 cm2) soaked in physiological salt
           solution. The electrodes are attached to the head with elasticated bands.

           Location of stimulation: Anode over the left dorsolateral cortex, corresponding with F3
           (in 10-20 EEG system); cathode over the right temporal cortex; Intensity: 2 mA; Total
           duration: Constant stimulation for 20 minutes, plus 15 seconds ramp-in and ramp-out
           phase during which the current will be regulated up and down, respectively.

           Stimulation time schedule: Each participant will be stimulated a total of 7 times over 7
           weeks.

           The stimulation will be followed by a 90-minute session of the 'Smoke-free programme'.

           The standardised behavioural therapy will be performed according to the certified
           "Smoke-free programme' of the of the Institute for Therapy Research ('Institut für
           Therapieforschung', IFT). The course leaders' manual specifies that the ideal number of
           participants is 8-12.

           IFT 6-week course

           Schedule:

           Duration: 7 weeks 1 group session for 90 minutes/week for 7 weeks 2 telephone calls of
           10 minutes each, first after the fourth session 3 days after collective smoking
           cessation, second on day 3 after the last session.

           Study procedures:

             -  1st session: Smoking and a smoke-free life

             -  2nd session: The smoker's ambivalence

             -  3rd session: Errors in reasoning and alternatives

             -  4th session: Preparing to quit smoking

           SMOKING CESSATION

             -  1st telephone call: Individual telephone support

             -  5th session: Experiences from quitting smoking

             -  6th session: Identity as a smoke-free person

             -  7th session: Planning the future

             -  2nd telephone call: Individual telephone support

        5. Evaluation scales

             -  Edinburgh Handedness Test: Test to assess left- or right-handedness to evaluate the
                dominant hemisphere.

             -  Comfort Rating Questionnaire: Questionnaire to record symptoms after tDCS

             -  Fagerström Test: Questionnaire to evaluate physical tobacco dependence

             -  Questionnaire on Smoking Urges (Tiffany & Drobes, 1991) (German version: Müller,
                Mucha, Ackermann & Pauli, 2001): Uses two scales to measure craving for cigarettes.

        6. Additional evaluations

           As an additional evaluation, at the start of the stimulation and at four follow-up
           appointments salivary cotinine (a degradation product of tobacco) and the carbon
           monoxide content of expired air will be measured. Carbon monoxide will be measured with
           a Micro Smokerlyzer (Bedfont Scientific Ltd., Maidstone, England).

           At the end of each tDCS treatment, the study participants will complete a Comfort Rating
           Questionnaire (CRQ). Our research group has used this questionnaire about direct current
           stimulation for several years and has continually improved and updated it. The
           questionnaire records unpleasant sensations and side effects during and after direct
           current stimulation.

        7. Sample size estimate

           Sample size estimation and study design correspond with the usual procedures in
           comparable pilot studies (e.g. on tDCS or TMS).

        8. Statistical analysis

      Data will be analysed with a multivariate analysis of covariance (MANCOVA). The absolute
      values of the evaluation scales will be the dependent variables and the treatment condition
      the independent factor.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: cessation rate
time frame: at 4 weeks after last intervention
description: salivary cotinine in ng/ml and the carbon monoxide content of expired air (COppm and %COHb)will be measured.
measure: Craving
time frame: week one directly before first tDCS intervention
description: Craving, assessed with a visual analog scale (VAS)and Questionnaire on Smoking Urges (QSU), is reduced significantly in the verum treatment group compared to the sham tDCS group.
measure: Craving
time frame: week two directly before second tDCS intervention
description: Craving, assessed with a visual analog scale (VAS)and Questionnaire on Smoking Urges (QSU), is reduced significantly in the verum treatment group compared to the sham tDCS group.
measure: Craving
time frame: week three directly before third tDCS intervention
description: Craving, assessed with a visual analog scale (VAS)and Questionnaire on Smoking Urges (QSU), is reduced significantly in the verum treatment group compared to the sham tDCS group.
measure: Craving
time frame: week four directly before fourth tDCS intervention
description: Craving, assessed with a visual analog scale (VAS)and Questionnaire on Smoking Urges (QSU), is reduced significantly in the verum treatment group compared to the sham tDCS group.
measure: Craving
time frame: week five directly before fifth tDCS intervention
description: Craving, assessed with a visual analog scale (VAS)and Questionnaire on Smoking Urges (QSU), is reduced significantly in the verum treatment group compared to the sham tDCS group.
measure: Craving
time frame: week six directly before sixth tDCS intervention
description: Craving, assessed with a visual analog scale (VAS)and Questionnaire on Smoking Urges (QSU), is reduced significantly in the verum treatment group compared to the sham tDCS group.
measure: Craving
time frame: week seven directly before seventh tDCS intervention
description: Craving, assessed with a visual analog scale (VAS)and Questionnaire on Smoking Urges (QSU), is reduced significantly in the verum treatment group compared to the sham tDCS group.
measure: Craving
time frame: four weeks after last intervention
description: Craving, assessed with a visual analog scale (VAS)and Questionnaire on Smoking Urges (QSU), is reduced significantly in the verum treatment group compared to the sham tDCS group.
measure: Craving
time frame: twelve weeks after last intervention
description: Craving, assessed with a visual analog scale (VAS)and Questionnaire on Smoking Urges (QSU), is reduced significantly in the verum treatment group compared to the sham tDCS group.
measure: cessation rate
time frame: at 12 weeks after last intervention
description: salivary cotinine in ng/ml and the carbon monoxide content of expired air (COppm and %COHb)will be measured.
arm group label: Treatment with tDCS
arm group type: Active Comparator
description: This group will receive 7x verum treatment with tDSC. All participants receive standardised behavioural therapy ('The smoke-free programme')
arm group label: 7x sham treatment
arm group type: Placebo Comparator
description: This group will receive 7x sham treatment. All participants will receive standardised behavioural therapy ('The smoke-free programme')
intervention type: Other
intervention name: tDCS
description: Stimulation will be performed with a DC stimulator MC Location of stimulation: Anode over the left dorsolateral cortex, corresponding with F3 (in 10-20 EEG system); cathode over the right temporal cortex Intensity: 2 mA Total duration: Constant stimulation for 20 minutes
arm group label: Treatment with tDCS
other name: Stimulator MC (neuroConn GmbH, Ilmenau, Germany).
intervention type: Behavioral
intervention name: standardised behavioural therapy
description: The standardised behavioural therapy will be performed according to the certified "Smoke-free programme' of the of the Institute for Therapy Research ('Institut für Therapieforschung', IFT). The course leaders' manual specifies that the ideal number of participants is 8-12.
1 group session for 90 minutes/week for 7 weeks, 2 telephone calls of 10 minutes each, first after the fourth session 3 days after collective smoking cessation, second on day 3 after the last session.
arm group label: 7x sham treatment
arm group label: Treatment with tDCS
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Frank Padberg, PD Dr.
role: Study Director
affiliation: Department of Psychotherapy and Psychosomatic Medicine
facility: 
status: Recruiting
contact: 
investigator: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Ludwig-Maximilians - University of Munich
investigator full name: Andrea Linhardt
investigator title: physician
mesh term: Tobacco Use Disorder