<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/NCT04501016</url>
  </required_header>
  <id_info>
    <org_study_id>IowacityVAMC</org_study_id>
    <nct_id>NCT04501016</nct_id>
  </id_info>
  <brief_title>A Stepped Care Approach to Treating Tobacco Use in Rural Veterans</brief_title>
  <acronym>Stepped Care</acronym>
  <official_title>A Stepped Care Approach to Treating Tobacco Use in Rural Veterans</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Iowa City Veterans Affairs Medical Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>US Department of Veterans Affairs</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>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Tobacco use remains prevalent among Veterans. Although effective smoking cessation&#xD;
      interventions exist, long-term term quit rates remain sub-optimal. The project will&#xD;
      investigate the feasibility of a stepped care approach to treating tobacco use that includes&#xD;
      enhancements based on initial response to treatment to augment the investigators' existing&#xD;
      tailored tobacco treatment intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rural tobacco users (cigarette smokers, smokeless tobacco users, and users of other forms of&#xD;
      tobacco) from the Iowa City VA Health Care System will be proactively recruited using&#xD;
      information obtained from the electronic medical record. All participants will receive the&#xD;
      investigators' tailored, six session smoking cessation intervention developed over a series&#xD;
      of projects funded by ORH. This includes a counseling protocol tailored to tobacco users'&#xD;
      individual needs and associated risk factors as well as pharmacotherapy selected using shared&#xD;
      decision making. Participants who are unable to quit initially will be provided with enhanced&#xD;
      counseling based on self-monitoring and scheduled reduced smoking. Those who are able to quit&#xD;
      using tobacco during the initial treatment phase will be given an extended, four-session&#xD;
      counseling protocol that incorporates new content based on established interventions from&#xD;
      positive psychology in an effort to reduce relapse.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 2020</start_date>
  <completion_date type="Anticipated">September 2023</completion_date>
  <primary_completion_date type="Anticipated">August 2021</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>All tobacco users will receive a tailored pharmacological and behavioral intervention. The specific counseling protocol will vary depending upon their response to treatment and initial success with quitting.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Tobacco cessation</measure>
    <time_frame>6 months</time_frame>
    <description>7-day point prevalence tobacco cessation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tobacco cessation</measure>
    <time_frame>3 months</time_frame>
    <description>7-day point prevalence tobacco cessation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Salivary cotinine levels (in ng/ml)</measure>
    <time_frame>6 months</time_frame>
    <description>Salivary cotinine</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Level of satisfaction with the intervention as measured according to a five-point scale (extremely, very, moderately, slightly, not at all)</measure>
    <time_frame>3 months</time_frame>
    <description>Self-reported satisfaction with the intervention according to the dimensions of usefulness, convenience, difficulty, liking, and helpfulness using five response options (extremely, very, moderately, slightly, not at all) using a scale developed specifically for the project.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Tobacco Cessation</condition>
  <arm_group>
    <arm_group_label>Tailored Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tailored behavioral counseling combined with tobacco cessation pharmacotherapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Tailored behavioral counseling</intervention_name>
    <description>Participants will initially receive a six-session telephone intervention. Standard cognitive behavioral treatment strategies will be included. Participants will be screened for elevated depressive symptoms, risky alcohol use, and concerns about weight and and offered supplemental behavioral counseling related to these issues as appropriate. Those that are unable to quit tobacco initially will receive an enhanced, four-session counseling module focused on reduced scheduled smoking. Those who do quit tobacco use initially will receive four sessions of extended counseling based on positive psychology intervention strategies.</description>
    <arm_group_label>Tailored Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tobacco cessation pharmacotherapy</intervention_name>
    <description>Pharmacotherapy will be selected based on medical and psychiatric history and potential interactions with other current medications combined with shared decision making. Options will include nicotine gum (2 and 4 mg), nicotine lozenge (2 and 4 mg), nicotine patch (7, 14, and 21 mg), bupropion (150 mg twice daily) and varenicline (1 mg twice daily). Monotherapy and combination therapy options will be provided.</description>
    <arm_group_label>Tailored Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Use tobacco (cigarettes, smokeless tobacco, pipes, cigars, hookah) on a daily basis&#xD;
&#xD;
          -  Be willing to make a quit attempt in the next 30 days&#xD;
&#xD;
          -  Able to provide informed consent&#xD;
&#xD;
          -  Have access to a telephone&#xD;
&#xD;
          -  Have a stable residence,&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Planning to move within the next 6 months&#xD;
&#xD;
          -  Terminal illness&#xD;
&#xD;
          -  Unstable psychiatric disorder (e.g., acute psychosis)&#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 Vander Weg, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Iowa City VA Health Care System</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Theresa Morano, MS</last_name>
    <phone>319-338-0581</phone>
    <phone_ext>63-7663</phone_ext>
    <email>theresa.morano@va.gov</email>
  </overall_contact>
  <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>August 2020</verification_date>
  <study_first_submitted>July 29, 2020</study_first_submitted>
  <study_first_submitted_qc>August 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>August 2, 2020</last_update_submitted>
  <last_update_submitted_qc>August 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal 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>Core Investigator</investigator_title>
  </responsible_party>
  <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/NCT04501016
org study id: IowacityVAMC
nct id: NCT04501016
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Tobacco use remains prevalent among Veterans. Although effective smoking cessation
      interventions exist, long-term term quit rates remain sub-optimal. The project will
      investigate the feasibility of a stepped care approach to treating tobacco use that includes
      enhancements based on initial response to treatment to augment the investigators' existing
      tailored tobacco treatment intervention.
Rural tobacco users (cigarette smokers, smokeless tobacco users, and users of other forms of
      tobacco) from the Iowa City VA Health Care System will be proactively recruited using
      information obtained from the electronic medical record. All participants will receive the
      investigators' tailored, six session smoking cessation intervention developed over a series
      of projects funded by ORH. This includes a counseling protocol tailored to tobacco users'
      individual needs and associated risk factors as well as pharmacotherapy selected using shared
      decision making. Participants who are unable to quit initially will be provided with enhanced
      counseling based on self-monitoring and scheduled reduced smoking. Those who are able to quit
      using tobacco during the initial treatment phase will be given an extended, four-session
      counseling protocol that incorporates new content based on established interventions from
      positive psychology in an effort to reduce relapse.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: All tobacco users will receive a tailored pharmacological and behavioral intervention. The specific counseling protocol will vary depending upon their response to treatment and initial success with quitting.
primary purpose: Treatment
masking: None (Open Label)
measure: Tobacco cessation
time frame: 6 months
description: 7-day point prevalence tobacco cessation
measure: Tobacco cessation
time frame: 3 months
description: 7-day point prevalence tobacco cessation
measure: Salivary cotinine levels (in ng/ml)
time frame: 6 months
description: Salivary cotinine
measure: Level of satisfaction with the intervention as measured according to a five-point scale (extremely, very, moderately, slightly, not at all)
time frame: 3 months
description: Self-reported satisfaction with the intervention according to the dimensions of usefulness, convenience, difficulty, liking, and helpfulness using five response options (extremely, very, moderately, slightly, not at all) using a scale developed specifically for the project.
arm group label: Tailored Intervention
arm group type: Experimental
description: Tailored behavioral counseling combined with tobacco cessation pharmacotherapy.
intervention type: Behavioral
intervention name: Tailored behavioral counseling
description: Participants will initially receive a six-session telephone intervention. Standard cognitive behavioral treatment strategies will be included. Participants will be screened for elevated depressive symptoms, risky alcohol use, and concerns about weight and and offered supplemental behavioral counseling related to these issues as appropriate. Those that are unable to quit tobacco initially will receive an enhanced, four-session counseling module focused on reduced scheduled smoking. Those who do quit tobacco use initially will receive four sessions of extended counseling based on positive psychology intervention strategies.
arm group label: Tailored Intervention
intervention type: Drug
intervention name: Tobacco cessation pharmacotherapy
description: Pharmacotherapy will be selected based on medical and psychiatric history and potential interactions with other current medications combined with shared decision making. Options will include nicotine gum (2 and 4 mg), nicotine lozenge (2 and 4 mg), nicotine patch (7, 14, and 21 mg), bupropion (150 mg twice daily) and varenicline (1 mg twice daily). Monotherapy and combination therapy options will be provided.
arm group label: Tailored Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mark Vander Weg, PhD
role: Principal Investigator
affiliation: Iowa City VA Health Care System
last name: Theresa Morano, MS
phone: 319-338-0581
phone ext: 63-7663
email: theresa.morano@va.gov
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Iowa City Veterans Affairs Medical Center
investigator full name: Mark Vander Weg
investigator title: Core Investigator
sharing ipd: No