<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/NCT02994082</url>
  </required_header>
  <id_info>
    <org_study_id>201611737</org_study_id>
    <nct_id>NCT02994082</nct_id>
  </id_info>
  <brief_title>Treating Smokeless Tobacco Use in Rural Veterans</brief_title>
  <official_title>Treating Smokeless Tobacco Use in Rural Veterans</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mark Vander Weg</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Iowa City VA Health Care System</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Iowa City Veterans Affairs Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a pilot study designed in an effort to develop and improve access to effective&#xD;
      treatments for tobacco use in rural Veterans using a tailored intervention approach.&#xD;
      Specifically, we will evaluate a combined behavioral and pharmacological smokeless tobacco&#xD;
      cessation which concomitantly addresses comorbid issues commonly experienced by rural tobacco&#xD;
      users including elevated depressive symptoms, risky alcohol use, and concerns about weight&#xD;
      gain. The objectives are to:&#xD;
&#xD;
        1. Evaluate the feasibility of an individually-tailored telephone intervention for rural&#xD;
           smokeless tobacco users&#xD;
&#xD;
        2. Examine the impact of the intervention on treatment utilization, patient satisfaction,&#xD;
           and smokeless tobacco cessation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">May 2020</completion_date>
  <primary_completion_date type="Anticipated">September 2019</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 (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Treatment satisfaction</measure>
    <time_frame>Three month follow-up</time_frame>
    <description>Participants' impressions of and satisfaction with their assigned intervention will be assessed via interview.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tobacco use</measure>
    <time_frame>Three-and six-month follow-up</time_frame>
    <description>At three- and six-months, participants will be questioned regarding tobacco use over the prior seven days (seven-day point prevalence abstinence). Those reporting abstinence at six-months will be asked to provide a saliva sample for measuring cotinine in order to biochemically verify self-reported tobacco use.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alcohol use</measure>
    <time_frame>Three- and six-month follow-up</time_frame>
    <description>Alcohol use during the previous seven days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depressive symptoms</measure>
    <time_frame>Three- and six-month follow-up</time_frame>
    <description>Depressive symptoms will be assessed using the Patient Health Questionnaire 9 (PHQ-9)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body weight</measure>
    <time_frame>Three- and six-month follow-up</time_frame>
    <description>Body weight will be assessed via self-report.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Enrollment rate</measure>
    <time_frame>Six months after study initiation</time_frame>
    <description>The number of participants enrolled will be tracked as a measure of the feasibility of the intervention approach.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Retention</measure>
    <time_frame>Six months after study initiation</time_frame>
    <description>The proportion of participants who remain in the study throughout the entire six-month study period will be determined as an indicator of the feasibility of the treatment approach.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment attendance</measure>
    <time_frame>Three-month follow-up</time_frame>
    <description>The number of treatment calls completed at the time of the three-month follow-up assessment will be determined for all participants in the Tailored intervention condition as an indicator of the feasibility of the treatment approach.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">123</enrollment>
  <condition>Smokeless Tobacco</condition>
  <condition>Nicotine Dependence</condition>
  <arm_group>
    <arm_group_label>Tailored Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The tailored behavioral intervention includes both behavioral and pharmacological components. The behavioral component will consist of six sessions of cognitive behavioral therapy and coping skills training delivered over the telephone. In addition, participants will be screened for conditions commonly associated with tobacco use (depressive symptoms, risky alcohol use, weight concerns) and offered supplementary behavioral treatment modules to address these issues. Participants will also be offered pharmacotherapy for tobacco cessation, with decisions regarding specific medication(s) based on patients' medical history, contraindications, prior experiences, and preferences.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Facilitated tobacco quit line referral</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants assigned to this condition will receive information about the VA telephone tobacco quit line and educational materials and encouraged to enroll in treatment. In addition, they will be given information regarding available medications for smoking cessation and encouraged to contact their primary care provider to discuss their options.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Tailored behavioral intervention</intervention_name>
    <description>Participants will receive a standard six session cognitive behavioral intervention for smokeless tobacco cessation combined with supplemental treatment modules based on individual need and preferences.</description>
    <arm_group_label>Tailored Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Behavioral activation for elevated depressive symptoms</intervention_name>
    <description>Participants with elevated depressive symptoms may receive this six session telephone-based behavioral activation intervention.</description>
    <arm_group_label>Tailored Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Post-cessation weight gain management</intervention_name>
    <description>Participants with concerns about gaining weight after quitting smokeless tobacco use may receive this six session telephone-based behavioral self-management intervention designed to help attenuate post-cessation weight gain.</description>
    <arm_group_label>Tailored Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Alcohol use risk reduction</intervention_name>
    <description>Participants engaging in risky alcohol use may receive this six session telephone-based behavioral intervention for reducing alcohol use.</description>
    <arm_group_label>Tailored Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nicotine replacement therapy - transdermal nicotine patch</intervention_name>
    <description>Medication selection will be based on individual participant preferences, medical history, and contraindications.</description>
    <arm_group_label>Tailored Intervention</arm_group_label>
    <other_name>Nicotine patch</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nicotine replacement therapy - nicotine lozenge</intervention_name>
    <description>Medication selection will be based on individual participant preferences, medical history, and contraindications.</description>
    <arm_group_label>Tailored Intervention</arm_group_label>
    <other_name>Nicotine lozenge</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nicotine replacement therapy - nicotine gum</intervention_name>
    <description>Medication selection will be based on individual participant preferences, medical history, and contraindications.</description>
    <arm_group_label>Tailored Intervention</arm_group_label>
    <other_name>Nicotine gum</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupropion sustained release</intervention_name>
    <description>Medication selection will be based on individual participant preferences, medical history, and contraindications.</description>
    <arm_group_label>Tailored Intervention</arm_group_label>
    <other_name>Zyban</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Varenicline</intervention_name>
    <description>Medication selection will be based on individual participant preferences, medical history, and contraindications.</description>
    <arm_group_label>Tailored Intervention</arm_group_label>
    <other_name>Chantix</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Combination nicotine replacement therapy</intervention_name>
    <description>Medication selection will be based on individual participant preferences, medical history, and contraindications. Possible combinations include nicotine patch + nicotine lozenge and nicotine patch + nicotine gum.</description>
    <arm_group_label>Tailored Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Combination nicotine replacement therapy + bupropion</intervention_name>
    <description>Medication selection will be based on individual participant preferences, medical history, and contraindications. Possible combinations include nicotine patch + bupropion, nicotine gum + bupropion, and nicotine lozenge + bupropion.</description>
    <arm_group_label>Tailored Intervention</arm_group_label>
    <other_name>Medication selection will be based on individual participant preferences, medical history, and contraindications.</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Tobacco quit line</intervention_name>
    <description>Referral to the Department of Veterans Affairs tobacco telephone quit line.</description>
    <arm_group_label>Facilitated tobacco quit line referral</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Educational materials</intervention_name>
    <description>Information regarding the VA tobacco quit line and associated treatment services, self-help materials for tobacco cessation, and information about tobacco cessation medications available in the VA,</description>
    <arm_group_label>Facilitated tobacco quit line referral</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Use smokeless tobacco on a daily basis&#xD;
&#xD;
          2. Be willing to make a quit attempt in the next 30 days&#xD;
&#xD;
          3. Reside in a rural location&#xD;
&#xD;
          4. Receiving care through the Iowa City VA Health Care System or an affiliated&#xD;
             community-based outpatient clinic&#xD;
&#xD;
          5. Able to provide informed consent&#xD;
&#xD;
          6. Telephone access&#xD;
&#xD;
          7. Stable residence&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Planning to move in the next 12 months&#xD;
&#xD;
          2. Terminal illness&#xD;
&#xD;
          3. Unstable psychiatric disorder&#xD;
&#xD;
          4. Incarcerated&#xD;
&#xD;
          5. Institutionalized&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mark W. Vander Weg, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Iowa City VA Health Care System</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Iowa City VA Healthcare System</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52246</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>December 8, 2016</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <last_update_submitted>July 22, 2019</last_update_submitted>
  <last_update_submitted_qc>July 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Iowa City Veterans Affairs Medical Center</investigator_affiliation>
    <investigator_full_name>Mark Vander Weg</investigator_full_name>
    <investigator_title>Reserach Specialist</investigator_title>
  </responsible_party>
  <keyword>Rural health</keyword>
  <keyword>Veterans</keyword>
  <keyword>Smokeless tobacco cessation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tobacco Use Disorder</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bupropion</mesh_term>
    <mesh_term>Nicotine</mesh_term>
    <mesh_term>Varenicline</mesh_term>
  </intervention_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/NCT02994082
org study id: 201611737
nct id: NCT02994082
lead sponsor: 
collaborator: 
has dmc: No
This is a pilot study designed in an effort to develop and improve access to effective
      treatments for tobacco use in rural Veterans using a tailored intervention approach.
      Specifically, we will evaluate a combined behavioral and pharmacological smokeless tobacco
      cessation which concomitantly addresses comorbid issues commonly experienced by rural tobacco
      users including elevated depressive symptoms, risky alcohol use, and concerns about weight
      gain. The objectives are to:

        1. Evaluate the feasibility of an individually-tailored telephone intervention for rural
           smokeless tobacco users

        2. Examine the impact of the intervention on treatment utilization, patient satisfaction,
           and smokeless tobacco cessation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Treatment satisfaction
time frame: Three month follow-up
description: Participants' impressions of and satisfaction with their assigned intervention will be assessed via interview.
measure: Tobacco use
time frame: Three-and six-month follow-up
description: At three- and six-months, participants will be questioned regarding tobacco use over the prior seven days (seven-day point prevalence abstinence). Those reporting abstinence at six-months will be asked to provide a saliva sample for measuring cotinine in order to biochemically verify self-reported tobacco use.
measure: Alcohol use
time frame: Three- and six-month follow-up
description: Alcohol use during the previous seven days.
measure: Depressive symptoms
time frame: Three- and six-month follow-up
description: Depressive symptoms will be assessed using the Patient Health Questionnaire 9 (PHQ-9)
measure: Body weight
time frame: Three- and six-month follow-up
description: Body weight will be assessed via self-report.
measure: Enrollment rate
time frame: Six months after study initiation
description: The number of participants enrolled will be tracked as a measure of the feasibility of the intervention approach.
measure: Retention
time frame: Six months after study initiation
description: The proportion of participants who remain in the study throughout the entire six-month study period will be determined as an indicator of the feasibility of the treatment approach.
measure: Treatment attendance
time frame: Three-month follow-up
description: The number of treatment calls completed at the time of the three-month follow-up assessment will be determined for all participants in the Tailored intervention condition as an indicator of the feasibility of the treatment approach.
arm group label: Tailored Intervention
arm group type: Experimental
description: The tailored behavioral intervention includes both behavioral and pharmacological components. The behavioral component will consist of six sessions of cognitive behavioral therapy and coping skills training delivered over the telephone. In addition, participants will be screened for conditions commonly associated with tobacco use (depressive symptoms, risky alcohol use, weight concerns) and offered supplementary behavioral treatment modules to address these issues. Participants will also be offered pharmacotherapy for tobacco cessation, with decisions regarding specific medication(s) based on patients' medical history, contraindications, prior experiences, and preferences.
arm group label: Facilitated tobacco quit line referral
arm group type: Active Comparator
description: Participants assigned to this condition will receive information about the VA telephone tobacco quit line and educational materials and encouraged to enroll in treatment. In addition, they will be given information regarding available medications for smoking cessation and encouraged to contact their primary care provider to discuss their options.
intervention type: Behavioral
intervention name: Tailored behavioral intervention
description: Participants will receive a standard six session cognitive behavioral intervention for smokeless tobacco cessation combined with supplemental treatment modules based on individual need and preferences.
arm group label: Tailored Intervention
intervention type: Behavioral
intervention name: Behavioral activation for elevated depressive symptoms
description: Participants with elevated depressive symptoms may receive this six session telephone-based behavioral activation intervention.
arm group label: Tailored Intervention
intervention type: Behavioral
intervention name: Post-cessation weight gain management
description: Participants with concerns about gaining weight after quitting smokeless tobacco use may receive this six session telephone-based behavioral self-management intervention designed to help attenuate post-cessation weight gain.
arm group label: Tailored Intervention
intervention type: Behavioral
intervention name: Alcohol use risk reduction
description: Participants engaging in risky alcohol use may receive this six session telephone-based behavioral intervention for reducing alcohol use.
arm group label: Tailored Intervention
intervention type: Drug
intervention name: Nicotine replacement therapy - transdermal nicotine patch
description: Medication selection will be based on individual participant preferences, medical history, and contraindications.
arm group label: Tailored Intervention
other name: Nicotine patch
intervention type: Drug
intervention name: Nicotine replacement therapy - nicotine lozenge
description: Medication selection will be based on individual participant preferences, medical history, and contraindications.
arm group label: Tailored Intervention
other name: Nicotine lozenge
intervention type: Drug
intervention name: Nicotine replacement therapy - nicotine gum
description: Medication selection will be based on individual participant preferences, medical history, and contraindications.
arm group label: Tailored Intervention
other name: Nicotine gum
intervention type: Drug
intervention name: Bupropion sustained release
description: Medication selection will be based on individual participant preferences, medical history, and contraindications.
arm group label: Tailored Intervention
other name: Zyban
intervention type: Drug
intervention name: Varenicline
description: Medication selection will be based on individual participant preferences, medical history, and contraindications.
arm group label: Tailored Intervention
other name: Chantix
intervention type: Drug
intervention name: Combination nicotine replacement therapy
description: Medication selection will be based on individual participant preferences, medical history, and contraindications. Possible combinations include nicotine patch + nicotine lozenge and nicotine patch + nicotine gum.
arm group label: Tailored Intervention
intervention type: Drug
intervention name: Combination nicotine replacement therapy + bupropion
description: Medication selection will be based on individual participant preferences, medical history, and contraindications. Possible combinations include nicotine patch + bupropion, nicotine gum + bupropion, and nicotine lozenge + bupropion.
arm group label: Tailored Intervention
other name: Medication selection will be based on individual participant preferences, medical history, and contraindications.
intervention type: Behavioral
intervention name: Tobacco quit line
description: Referral to the Department of Veterans Affairs tobacco telephone quit line.
arm group label: Facilitated tobacco quit line referral
intervention type: Behavioral
intervention name: Educational materials
description: Information regarding the VA tobacco quit line and associated treatment services, self-help materials for tobacco cessation, and information about tobacco cessation medications available in the VA,
arm group label: Facilitated tobacco quit line referral
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mark W. Vander Weg, PhD
role: Principal Investigator
affiliation: Iowa City VA Health Care System
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Iowa City Veterans Affairs Medical Center
investigator full name: Mark Vander Weg
investigator title: Reserach Specialist
mesh term: Tobacco Use Disorder
mesh term: Bupropion
mesh term: Nicotine
mesh term: Varenicline
sharing ipd: No