<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/NCT01710410</url>
  </required_header>
  <id_info>
    <org_study_id>016-2015</org_study_id>
    <nct_id>NCT01710410</nct_id>
  </id_info>
  <brief_title>Transcranial Direct Current Stimulation in a Smoking Cessation Trial</brief_title>
  <acronym>tDCS</acronym>
  <official_title>Pilot Study of Transcranial Direct Current Stimulation (tDCS) as a Smoking Cessation Treatment for Nicotine Dependent Smokers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre for Addiction and Mental Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Nuraleve, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre for Addiction and Mental Health</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the effectiveness of transcranial direct current&#xD;
      stimulation (tDCS) plus nicotine patch as a viable smoking cessation program for nicotine&#xD;
      dependent smokers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      BACKGROUND: Transcranial direct current stimulation (tDCS) is a form of non-invasive brain&#xD;
      stimulation that involves the application of brief weak electric current to the scalp. tDCS&#xD;
      may induce neuroplasticity, thereby engaging some of the same systems that figure prominently&#xD;
      in the pathological neuroplasticity caused by addictive drugs.&#xD;
&#xD;
      OBJECTIVE: To assess whether tDCS delivered along with nicotine patch reliably increases a)&#xD;
      quit rates, b) duration of abstinence, and c) percentage of participants abstinent at&#xD;
      follow-up.&#xD;
&#xD;
      METHOD: Active (20min; 2mA) and sham (30sec; 2mA) stimulation will be applied to the&#xD;
      dorsolateral prefrontal cortex (DLPFC) in both cerebral hemispheres.&#xD;
&#xD;
      HYPOTHESES:&#xD;
&#xD;
        1. Active tDCS (20-min; 2 mA) will increase abstinence in a standard smoking cessation&#xD;
           protocol relative to a sham procedure.&#xD;
&#xD;
        2. The benefits of active left anodal stimulation (anode-left/cathode-right) to the DLPFC&#xD;
           will be greater than of active tDCS in the reverse configuration&#xD;
           (cathode-left/anode-right).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Funding&#xD;
  </why_stopped>
  <start_date>October 2016</start_date>
  <completion_date type="Anticipated">October 2016</completion_date>
  <primary_completion_date type="Anticipated">October 2016</primary_completion_date>
  <phase>Phase 2</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, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Smoking Cessation</measure>
    <time_frame>Participants will be followed for the duration of the study, an expected average of 9 months.</time_frame>
    <description>Measure whether active tDCS increases abstinence in a standard smoking cessation protocol relative to a sham tDCS procedure</description>
  </primary_outcome>
  <other_outcome>
    <measure>Smoking cessation rate following transcranial direct current stimulation (tDCS) applied to the left dorsolateral prefrontal cortex (DLPFC) versus the right DLPFC.</measure>
    <time_frame>Participants will be followed for the duration of the study, an expected average of 9 months.</time_frame>
    <description>Measure whether the benefits of active tDCS (anode-left/cathode-right) to the DLPFC will be greater than of active tDCS in the reverse configuration (cathode-left/anode-right) to that region.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Nicotine Dependence</condition>
  <arm_group>
    <arm_group_label>DLPFC tDCS (left anode/right cathode)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Active transcranial Direct Current Stimulation (tDCS) administered to the left DLPFC. Brief (20-min) application of weak electric current (e.g., 2 mA) to the scalp.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DLPFC tDCS (left cathode/right anode)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Active transcranial Direct Current Stimulation (tDCS) administered to the right DLPFC. Brief (20-min) application of weak electric current (e.g., 2 mA) to the scalp.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DLPFC tDCS</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Sham transcranial Direct Current Stimulation (tDCS) delivered to the DLPFC. Brief (30-sec) application of weak electric current (e.g., 2mA) to the scalp.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>active transcranial Direct Current Stimulation</intervention_name>
    <description>Brief (20-min) application of weak electric current (e.g., 2 mA) to the scalp.</description>
    <arm_group_label>DLPFC tDCS (left anode/right cathode)</arm_group_label>
    <arm_group_label>DLPFC tDCS (left cathode/right anode)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>sham transcranial Direct Current Stimulation</intervention_name>
    <description>Brief (30-sec) application of weak electric current (e.g., 2mA) to the scalp.</description>
    <arm_group_label>DLPFC tDCS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  nicotine dependent&#xD;
&#xD;
          -  treatment-seeking&#xD;
&#xD;
          -  smoke minimum of 15 cigarettes per day&#xD;
&#xD;
          -  able to provide written informed consent&#xD;
&#xD;
          -  able and willing to attend weekly appointments, inter-treatment and follow-up&#xD;
             assessment&#xD;
&#xD;
          -  able and willing to wear nicotine patch&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  currently taking GABA receptor agonists, NMDA receptor antagonists, dopamine receptor&#xD;
             agonists/antagonists, SSRIs, L-dopa, anticholinergics&#xD;
&#xD;
          -  pregnancy or lactation&#xD;
&#xD;
          -  any serious medical condition requiring treatment or medication including high blood&#xD;
             pressure, heart problems, asthma, epilepsy&#xD;
&#xD;
          -  brain/neurological injury/disease/disorder&#xD;
&#xD;
          -  skin disease&#xD;
&#xD;
          -  current DSM-IV Axis I psychiatric disorder&#xD;
&#xD;
          -  metal or medical device implants&#xD;
&#xD;
          -  current treatment for alcohol or drug use&#xD;
&#xD;
          -  current use of herbal/holistic preparations&#xD;
&#xD;
          -  current use of recreational drugs&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Laurie Zawertailo, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre for Addiction and Mental Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre for Addiction and Mental Health (Nicotine Dependence Clinic)</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5T 1P5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <link>
    <url>http://www.camh.ca</url>
    <description>Centre for Addiction and Mental Health (investigator-driven, not initiated, study)</description>
  </link>
  <link>
    <url>http://www.braininstitute.ca/</url>
    <description>Ontario Brain Institute</description>
  </link>
  <link>
    <url>http://www.nuraleve.com</url>
    <description>Nuraleve, Inc. (regulatory sponsor with Health Canada)</description>
  </link>
  <reference>
    <citation>Boggio PS, Liguori P, Sultani N, Rezende L, Fecteau S, Fregni F. Cumulative priming effects of cortical stimulation on smoking cue-induced craving. Neurosci Lett. 2009 Sep 29;463(1):82-6. doi: 10.1016/j.neulet.2009.07.041. Epub 2009 Jul 18.</citation>
    <PMID>19619607</PMID>
  </reference>
  <reference>
    <citation>Feil J, Zangen A. Brain stimulation in the study and treatment of addiction. Neurosci Biobehav Rev. 2010 Mar;34(4):559-74. doi: 10.1016/j.neubiorev.2009.11.006. Epub 2009 Nov 13.</citation>
    <PMID>19914283</PMID>
  </reference>
  <reference>
    <citation>Fregni F, Liguori P, Fecteau S, Nitsche MA, Pascual-Leone A, Boggio PS. Cortical stimulation of the prefrontal cortex with transcranial direct current stimulation reduces cue-provoked smoking craving: a randomized, sham-controlled study. J Clin Psychiatry. 2008 Jan;69(1):32-40. doi: 10.4088/jcp.v69n0105.</citation>
    <PMID>18312035</PMID>
  </reference>
  <verification_date>June 2016</verification_date>
  <study_first_submitted>September 21, 2012</study_first_submitted>
  <study_first_submitted_qc>October 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 19, 2012</study_first_posted>
  <last_update_submitted>June 9, 2016</last_update_submitted>
  <last_update_submitted_qc>June 9, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 13, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centre for Addiction and Mental Health</investigator_affiliation>
    <investigator_full_name>Laurie Zawertailo</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>transcranial direct current stimulation</keyword>
  <keyword>nicotine dependence</keyword>
  <keyword>dorsolateral prefrontal cortex</keyword>
  <keyword>nicotine replacement therapy</keyword>
  <keyword>nicotine patch</keyword>
  <keyword>addiction</keyword>
  <keyword>smoking cessation</keyword>
  <keyword>neuroplasticity</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/NCT01710410
org study id: 016-2015
nct id: NCT01710410
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to determine the effectiveness of transcranial direct current
      stimulation (tDCS) plus nicotine patch as a viable smoking cessation program for nicotine
      dependent smokers.
BACKGROUND: Transcranial direct current stimulation (tDCS) is a form of non-invasive brain
      stimulation that involves the application of brief weak electric current to the scalp. tDCS
      may induce neuroplasticity, thereby engaging some of the same systems that figure prominently
      in the pathological neuroplasticity caused by addictive drugs.

      OBJECTIVE: To assess whether tDCS delivered along with nicotine patch reliably increases a)
      quit rates, b) duration of abstinence, and c) percentage of participants abstinent at
      follow-up.

      METHOD: Active (20min; 2mA) and sham (30sec; 2mA) stimulation will be applied to the
      dorsolateral prefrontal cortex (DLPFC) in both cerebral hemispheres.

      HYPOTHESES:

        1. Active tDCS (20-min; 2 mA) will increase abstinence in a standard smoking cessation
           protocol relative to a sham procedure.

        2. The benefits of active left anodal stimulation (anode-left/cathode-right) to the DLPFC
           will be greater than of active tDCS in the reverse configuration
           (cathode-left/anode-right).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Smoking Cessation
time frame: Participants will be followed for the duration of the study, an expected average of 9 months.
description: Measure whether active tDCS increases abstinence in a standard smoking cessation protocol relative to a sham tDCS procedure
measure: Smoking cessation rate following transcranial direct current stimulation (tDCS) applied to the left dorsolateral prefrontal cortex (DLPFC) versus the right DLPFC.
time frame: Participants will be followed for the duration of the study, an expected average of 9 months.
description: Measure whether the benefits of active tDCS (anode-left/cathode-right) to the DLPFC will be greater than of active tDCS in the reverse configuration (cathode-left/anode-right) to that region.
arm group label: DLPFC tDCS (left anode/right cathode)
arm group type: Experimental
description: Active transcranial Direct Current Stimulation (tDCS) administered to the left DLPFC. Brief (20-min) application of weak electric current (e.g., 2 mA) to the scalp.
arm group label: DLPFC tDCS (left cathode/right anode)
arm group type: Experimental
description: Active transcranial Direct Current Stimulation (tDCS) administered to the right DLPFC. Brief (20-min) application of weak electric current (e.g., 2 mA) to the scalp.
arm group label: DLPFC tDCS
arm group type: Sham Comparator
description: Sham transcranial Direct Current Stimulation (tDCS) delivered to the DLPFC. Brief (30-sec) application of weak electric current (e.g., 2mA) to the scalp.
intervention type: Device
intervention name: active transcranial Direct Current Stimulation
description: Brief (20-min) application of weak electric current (e.g., 2 mA) to the scalp.
arm group label: DLPFC tDCS (left anode/right cathode)
arm group label: DLPFC tDCS (left cathode/right anode)
intervention type: Device
intervention name: sham transcranial Direct Current Stimulation
description: Brief (30-sec) application of weak electric current (e.g., 2mA) to the scalp.
arm group label: DLPFC tDCS
criteria: 
gender: All
minimum age: 19 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Laurie Zawertailo, Ph.D.
role: Principal Investigator
affiliation: Centre for Addiction and Mental Health
facility: 
country: Canada
url: http://www.camh.ca
description: Centre for Addiction and Mental Health (investigator-driven, not initiated, study)
url: http://www.braininstitute.ca/
description: Ontario Brain Institute
url: http://www.nuraleve.com
description: Nuraleve, Inc. (regulatory sponsor with Health Canada)
citation: Boggio PS, Liguori P, Sultani N, Rezende L, Fecteau S, Fregni F. Cumulative priming effects of cortical stimulation on smoking cue-induced craving. Neurosci Lett. 2009 Sep 29;463(1):82-6. doi: 10.1016/j.neulet.2009.07.041. Epub 2009 Jul 18.
PMID: 19619607
citation: Feil J, Zangen A. Brain stimulation in the study and treatment of addiction. Neurosci Biobehav Rev. 2010 Mar;34(4):559-74. doi: 10.1016/j.neubiorev.2009.11.006. Epub 2009 Nov 13.
PMID: 19914283
citation: Fregni F, Liguori P, Fecteau S, Nitsche MA, Pascual-Leone A, Boggio PS. Cortical stimulation of the prefrontal cortex with transcranial direct current stimulation reduces cue-provoked smoking craving: a randomized, sham-controlled study. J Clin Psychiatry. 2008 Jan;69(1):32-40. doi: 10.4088/jcp.v69n0105.
PMID: 18312035
responsible party type: Principal Investigator
investigator affiliation: Centre for Addiction and Mental Health
investigator full name: Laurie Zawertailo
investigator title: Principal Investigator
mesh term: Tobacco Use Disorder