<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/NCT02192762</url>
  </required_header>
  <id_info>
    <org_study_id>F110601002</org_study_id>
    <nct_id>NCT02192762</nct_id>
  </id_info>
  <brief_title>Withdrawal Exposure With Withdrawal Regulation Training for Smoking Cessation</brief_title>
  <official_title>A Pilot Study of Withdrawal Regulation Training vs. Relaxation Training for Smoking Cessation (Withdrawal Exposure With Withdrawal Regulation Training for Smoking Cessation)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alabama at Birmingham</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a pilot study of a withdrawal regulation training program compared to relaxation&#xD;
      training for individuals that are interested in smoking cessation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will be recruited through newspaper and internet advertisements, advertisements&#xD;
      on public transportation, community centers and community based organizations. All&#xD;
      recruitment materials will contain a toll-free telephone number with 24-hour voice mail. The&#xD;
      first contact with potential participant will be by telephone interview to assess for&#xD;
      eligibility of participant. Participants who meet eligibility criteria will be invited to an&#xD;
      orientation meeting where a breath carbon monoxide sample will be obtained. Women participant&#xD;
      of childbearing potential will have a pregnancy test administered.&#xD;
&#xD;
      Participants will be randomized to one of two conditions: Early Withdrawal Exposure +&#xD;
      Withdrawal Relaxation Training (E+WT) or Relaxation Training (RT) control. The E+WT condition&#xD;
      will consist of the development, application, modification, and repeated practice of&#xD;
      individualized withdrawal regulation for behavioral and cognitive strategies. the RT&#xD;
      condition will control for the therapeutic contact received by those in the E+WT condition&#xD;
      and will consist of the development, application, modification, and repeated practice of&#xD;
      individualized relaxation techniques (e.g. breathing exercises, imagery).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2011</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</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>Triple (Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Biochemically verified smoking abstinence</measure>
    <time_frame>2 months after end-of-treatment</time_frame>
    <description>Smoking abstinence will be determined by self-report and confirmed via breath carbon monoxide (CO) analysis. Self-report of no smoking over the past 7 days (7-day point prevalence abstinence) and a CO value of less than 8 parts per million will be indicative of smoking abstinence. Self-report of any smoking over the past 7 days and/or CO values of 8 or greater will be indicative of cigarette use.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Biochemically-verified smoking abstinence</measure>
    <time_frame>3 months after end-of-treatment</time_frame>
    <description>Smoking abstinence will be determined by self-report and confirmed via breath carbon monoxide (CO) analysis. Self-report of no smoking over the past 7 days (7-day point prevalence abstinence) and a CO value of less than 8 parts per million will be indicative of smoking abstinence. Self-report of any smoking over the past 7 days and/or CO values of 8 or greater will be indicative of cigarette use.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Withdrawal symptoms</measure>
    <time_frame>2 months after end-of-treatment</time_frame>
    <description>Withdrawal symptoms will be measured via self-report with the Wisconsin Smoking Withdrawal Scale (WSWS), a reliable and valid instrument of smoking withdrawal symptomatology.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Withdrawal symptoms</measure>
    <time_frame>3 months after end-of-treament</time_frame>
    <description>Withdrawal symptoms will be measured via self-report with the Wisconsin Smoking Withdrawal Scale (WSWS), a reliable and valid instrument of smoking withdrawal symptomatology.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Smoking Cessation</condition>
  <arm_group>
    <arm_group_label>Withdrawal regulation training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Withdrawal coping skills</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Relaxation training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Relaxation skills instruction</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Withdrawal regulation training</intervention_name>
    <description>Withdrawal coping skills</description>
    <arm_group_label>Withdrawal regulation training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Relaxation training</intervention_name>
    <description>Relaxation skills instruction</description>
    <arm_group_label>Relaxation training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women at least 19 years of age&#xD;
&#xD;
          -  Reports smoking at least 10 cigarettes per day&#xD;
&#xD;
          -  Must have expired breath carbon monoxide reading of at least eight parts per million&#xD;
&#xD;
          -  Report the intention to quit smoking&#xD;
&#xD;
          -  Reside in the Birmingham area with no plan to relocate outside of the area in the next&#xD;
             six months&#xD;
&#xD;
          -  Have access to a telephone for scheduling follow up assessments&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to speak English&#xD;
&#xD;
          -  Presence of a condition that contraindicates use of transdermal nicotine patch (i.e.&#xD;
             angina pectoris, arrhythmia, recent myocardial infarction, allergies to adhesives,&#xD;
             serious skin disorders, and current pregnancy or breast feeding)&#xD;
&#xD;
          -  Presence of conditions that might interfere with compliance with protocol or greatly&#xD;
             complicate treatment (i.e. current alcohol or other substance dependence, dementia,&#xD;
             psychosis, schizophrenia, bipolar disorder, suicidal or homicidal ideation, and any&#xD;
             disease acutely life-threatening or so severe that the participant cannot comply with&#xD;
             the protocol)&#xD;
&#xD;
          -  Concurrent participation in a formal treatment program for smoking cessation&#xD;
&#xD;
          -  Current use of any pharmacotherapy for smoking cessation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter S Hendricks, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alabama at Birmingham</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama at Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>April 10, 2014</study_first_submitted>
  <study_first_submitted_qc>July 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 17, 2014</study_first_posted>
  <last_update_submitted>December 26, 2021</last_update_submitted>
  <last_update_submitted_qc>December 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 13, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alabama at Birmingham</investigator_affiliation>
    <investigator_full_name>Peter Hendricks</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <!-- 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/NCT02192762
org study id: F110601002
nct id: NCT02192762
lead sponsor: 
has dmc: No
This is a pilot study of a withdrawal regulation training program compared to relaxation
      training for individuals that are interested in smoking cessation.
Participants will be recruited through newspaper and internet advertisements, advertisements
      on public transportation, community centers and community based organizations. All
      recruitment materials will contain a toll-free telephone number with 24-hour voice mail. The
      first contact with potential participant will be by telephone interview to assess for
      eligibility of participant. Participants who meet eligibility criteria will be invited to an
      orientation meeting where a breath carbon monoxide sample will be obtained. Women participant
      of childbearing potential will have a pregnancy test administered.

      Participants will be randomized to one of two conditions: Early Withdrawal Exposure +
      Withdrawal Relaxation Training (E+WT) or Relaxation Training (RT) control. The E+WT condition
      will consist of the development, application, modification, and repeated practice of
      individualized withdrawal regulation for behavioral and cognitive strategies. the RT
      condition will control for the therapeutic contact received by those in the E+WT condition
      and will consist of the development, application, modification, and repeated practice of
      individualized relaxation techniques (e.g. breathing exercises, imagery).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Care Provider, Investigator, Outcomes Assessor)
measure: Biochemically verified smoking abstinence
time frame: 2 months after end-of-treatment
description: Smoking abstinence will be determined by self-report and confirmed via breath carbon monoxide (CO) analysis. Self-report of no smoking over the past 7 days (7-day point prevalence abstinence) and a CO value of less than 8 parts per million will be indicative of smoking abstinence. Self-report of any smoking over the past 7 days and/or CO values of 8 or greater will be indicative of cigarette use.
measure: Biochemically-verified smoking abstinence
time frame: 3 months after end-of-treatment
description: Smoking abstinence will be determined by self-report and confirmed via breath carbon monoxide (CO) analysis. Self-report of no smoking over the past 7 days (7-day point prevalence abstinence) and a CO value of less than 8 parts per million will be indicative of smoking abstinence. Self-report of any smoking over the past 7 days and/or CO values of 8 or greater will be indicative of cigarette use.
measure: Withdrawal symptoms
time frame: 2 months after end-of-treatment
description: Withdrawal symptoms will be measured via self-report with the Wisconsin Smoking Withdrawal Scale (WSWS), a reliable and valid instrument of smoking withdrawal symptomatology.
measure: Withdrawal symptoms
time frame: 3 months after end-of-treament
description: Withdrawal symptoms will be measured via self-report with the Wisconsin Smoking Withdrawal Scale (WSWS), a reliable and valid instrument of smoking withdrawal symptomatology.
arm group label: Withdrawal regulation training
arm group type: Experimental
description: Withdrawal coping skills
arm group label: Relaxation training
arm group type: Active Comparator
description: Relaxation skills instruction
intervention type: Behavioral
intervention name: Withdrawal regulation training
description: Withdrawal coping skills
arm group label: Withdrawal regulation training
intervention type: Behavioral
intervention name: Relaxation training
description: Relaxation skills instruction
arm group label: Relaxation training
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Peter S Hendricks, PhD
role: Principal Investigator
affiliation: University of Alabama at Birmingham
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Alabama at Birmingham
investigator full name: Peter Hendricks
investigator title: Principal Investigator