<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/NCT01734330</url>
  </required_header>
  <id_info>
    <org_study_id>119/2010</org_study_id>
    <nct_id>NCT01734330</nct_id>
  </id_info>
  <brief_title>Cognitive Behaviour Therapy and Nicotine Replacement to Increase Tobacco Cessation</brief_title>
  <official_title>Efficacy of Cognitive Behaviour Therapy Associated to Nicotine Replacement in Tobacco Cessation: a Randomised Open Label Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital do Coracao</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Health, Brazil</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital do Coracao</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: Pharmacological strategies to improve smoking cessation have been largely&#xD;
      studied. The efficacy of cognitive behavior therapy associated to nicotine replacement in&#xD;
      tobacco cessation has not yet been demonstrated.&#xD;
&#xD;
      Objective: Evaluate if cognitive behavior therapy during six weeks associated to nicotine&#xD;
      replacement for twelve weeks is able to contribute to tobacco cessation at the end of 52&#xD;
      weeks.&#xD;
&#xD;
      Methods: Multicentre, open-label, and pragmatic randomized controlled trial will include 334&#xD;
      patients. Analysis will follow intention-to-treat principle.&#xD;
&#xD;
      Patients older than 18 years old and who had smoked at least 5 cigarettes in the past year&#xD;
      before randomization will be included.&#xD;
&#xD;
      All of them will receive nicotine replacement therapy with patches and gum. They will be&#xD;
      randomized 1:1 ratio to attend or not cognitive behavior therapy once a week for the first&#xD;
      six weeks of the treatment. Every two weeks all of the patients will be evaluated by a&#xD;
      physician in order to access any adverse effects from the nicotine replacement.&#xD;
&#xD;
      All patients will have carbon monoxide levels accessed at baseline and after 6 weeks.&#xD;
      Telephonic interview will be done at 16, 28, and 52 weeks to access the rates of tobacco&#xD;
      cessation, relapses episodes and abstinence maintenance.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2010</start_date>
  <completion_date type="Actual">November 2012</completion_date>
  <primary_completion_date type="Actual">September 2012</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Smoking cessation</measure>
    <time_frame>52 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Levels of anxiety</measure>
    <time_frame>6 weeks</time_frame>
    <description>Evaluated by the State-Trait Anxiety Inventory</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Levels of depression</measure>
    <time_frame>6 weeks</time_frame>
    <description>Evaluated by Beck Depression Inventory</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Smoking Relapse rates</measure>
    <time_frame>52 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Smokers</condition>
  <arm_group>
    <arm_group_label>Cognitive behavior therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cognitive behavior therapy for 6 weeks associated to nicotine replacement for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nicotine replacement</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Nicotine replacement for 12 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive behavioral therapy in group</intervention_name>
    <arm_group_label>Cognitive behavior therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nicotine replacement</intervention_name>
    <arm_group_label>Cognitive behavior therapy</arm_group_label>
    <arm_group_label>Nicotine replacement</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Smokers (≥ 5 cigarettes/day during the previous year) who had not had a period of&#xD;
             abstinence greater than 3 months before randomization&#xD;
&#xD;
          -  Age ≥ 18 years &lt; 75 years;&#xD;
&#xD;
          -  Capable of reading and understanding Portuguese;&#xD;
&#xD;
          -  Willing to quit smoking.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Dementia;&#xD;
&#xD;
          -  Alcoholism;&#xD;
&#xD;
          -  Regular use of illicit drugs;&#xD;
&#xD;
          -  Panic disorders;&#xD;
&#xD;
          -  Psychosis;&#xD;
&#xD;
          -  Current pregnancy;&#xD;
&#xD;
          -  History of bipolar disturbance;&#xD;
&#xD;
          -  Contraindication to nicotine patches;&#xD;
&#xD;
          -  Prior use of bupropion and/or varenicline in the previous 12 months before&#xD;
             randomization;&#xD;
&#xD;
          -  Patients who refused to provide informed consent;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Silvia Ismael</last_name>
    <role>Study Chair</role>
    <affiliation>Hospital do Coração</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Instituto de Medicina Integral Professor Fernando Figueira - IMIP</name>
      <address>
        <city>Recife</city>
        <state>Pernanbuco</state>
        <zip>50070-550</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital do Coração</name>
      <address>
        <city>São Paulo</city>
        <state>SP</state>
        <zip>04005000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 22, 2012</study_first_submitted>
  <study_first_submitted_qc>November 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 27, 2012</study_first_posted>
  <last_update_submitted>November 26, 2012</last_update_submitted>
  <last_update_submitted_qc>November 26, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 27, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>behavior cognitive therapy</keyword>
  <keyword>Smokers</keyword>
  <keyword>randomized clinical trial</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nicotine</mesh_term>
  </intervention_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/NCT01734330
org study id: 119/2010
nct id: NCT01734330
lead sponsor: 
collaborator: 
has dmc: No
Background: Pharmacological strategies to improve smoking cessation have been largely
      studied. The efficacy of cognitive behavior therapy associated to nicotine replacement in
      tobacco cessation has not yet been demonstrated.

      Objective: Evaluate if cognitive behavior therapy during six weeks associated to nicotine
      replacement for twelve weeks is able to contribute to tobacco cessation at the end of 52
      weeks.

      Methods: Multicentre, open-label, and pragmatic randomized controlled trial will include 334
      patients. Analysis will follow intention-to-treat principle.

      Patients older than 18 years old and who had smoked at least 5 cigarettes in the past year
      before randomization will be included.

      All of them will receive nicotine replacement therapy with patches and gum. They will be
      randomized 1:1 ratio to attend or not cognitive behavior therapy once a week for the first
      six weeks of the treatment. Every two weeks all of the patients will be evaluated by a
      physician in order to access any adverse effects from the nicotine replacement.

      All patients will have carbon monoxide levels accessed at baseline and after 6 weeks.
      Telephonic interview will be done at 16, 28, and 52 weeks to access the rates of tobacco
      cessation, relapses episodes and abstinence maintenance.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Smoking cessation
time frame: 52 weeks
measure: Levels of anxiety
time frame: 6 weeks
description: Evaluated by the State-Trait Anxiety Inventory
measure: Levels of depression
time frame: 6 weeks
description: Evaluated by Beck Depression Inventory
measure: Smoking Relapse rates
time frame: 52 weeks
arm group label: Cognitive behavior therapy
arm group type: Experimental
description: Cognitive behavior therapy for 6 weeks associated to nicotine replacement for 12 weeks
arm group label: Nicotine replacement
arm group type: Other
description: Nicotine replacement for 12 weeks
intervention type: Behavioral
intervention name: Cognitive behavioral therapy in group
arm group label: Cognitive behavior therapy
intervention type: Drug
intervention name: Nicotine replacement
arm group label: Cognitive behavior therapy
arm group label: Nicotine replacement
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Silvia Ismael
role: Study Chair
affiliation: Hospital do Coração
facility: 
facility: 
country: Brazil
responsible party type: Sponsor
mesh term: Nicotine