<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/NCT02201810</url>
  </required_header>
  <id_info>
    <org_study_id>FWH20140076H</org_study_id>
    <nct_id>NCT02201810</nct_id>
  </id_info>
  <brief_title>Enhancing the Efficacy of Smoking Quit Line in the Military (AFIII Renewal)</brief_title>
  <acronym>Freedom</acronym>
  <official_title>Enhancing the Efficacy of Smoking Quit Line in the Military</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Virginia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Tennessee</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Virginia</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a randomized clinical trial designed to measure the effectiveness of three QL&#xD;
      interventions for smokers who failed to quit an initial smoking cessation intervention, but&#xD;
      remain motivated to quit smoking.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the investigators' previous QL protocol, FWH20080093H, the investigators documented that a&#xD;
      military-tailored QL was associated with high rates of sustained smoking cessation. The&#xD;
      proactive QL produced superior cessation rates at a one year follow-up compared to a reactive&#xD;
      QL. Unfortunately, even with high rates of cessation, a large number of participants (the&#xD;
      majority of participants) fail to remain quit at follow-up. Civilian QLs have observed the&#xD;
      same marked decay of sustained cessation rates from the end of treatment to the one year&#xD;
      follow-up.&#xD;
&#xD;
      An opportunity exists to reengage these smokers who relapse or fail to quit by the end of QL&#xD;
      treatment. Civilian QLs use one of two treatments, Recycling (repeat the smoking cessation&#xD;
      counseling) or Rate Reduction (cut down over time), as the primary methods for treatment&#xD;
      reengagement. Unfortunately, these methods of reengaging the relapsed/failed to quit smoker&#xD;
      have not been systematically evaluated. As such, we propose to randomize participants who&#xD;
      relapse or fail to quit by the end of the intervention to either (1) repeating the proactive&#xD;
      QL (Recycle); (2) smoking reduction with the goal of eventual cessation (Rate Reduction); or&#xD;
      (3) the choice of Recycle or Rate Reduction (Choice). Efficacy will be established by&#xD;
      assessing both point prevalence and continuous abstinence at a 12 month follow-up.&#xD;
&#xD;
      All participants (approximately 1900) are consented to follow-up treatment reengagement since&#xD;
      we do not know a priori who will quit and who will not quit/relapse. The investigators&#xD;
      anticipate, based on the investigators' QL study that about 30% will quit and remain quit&#xD;
      based on the eight-week proactive QL and about 70% will either not quit or relapse (n≈1300).&#xD;
      Those that are smoking at the three-month follow-up are stratified (based on whether they&#xD;
      quit and relapsed vs. not quitting at all in the Proactive QL based upon self-report) and&#xD;
      randomized to the three treatment reengagement strategies (Recycle, Rate Reduction, or&#xD;
      Choice), each one lasting 8 weeks. Then, at one year follow-up, the investigators will assess&#xD;
      both point prevalence and continuous abstinence. Since we are intervening on those that&#xD;
      initially failed to quit or relapsed, continuous abstinence will be defined from the point of&#xD;
      the last treatment reengagement intervention (one year from that point).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2015</start_date>
  <completion_date type="Actual">November 30, 2020</completion_date>
  <primary_completion_date type="Actual">November 30, 2020</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Effectiveness of randomized reengagement interventions</measure>
    <time_frame>From 3 months follow up to 1 year follow up</time_frame>
    <description>We will assess tobacco status (both 7-day point prevalence and continuous abstinence) at the follow-up period (one year after reengagement interventions are completed) to assess outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>One-year outcome from the initially successful group that quit smoking</measure>
    <time_frame>1-yr after initial randomization</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">614</enrollment>
  <condition>Initial Efficacy of Quit Line</condition>
  <condition>Efficacy of Secondary Reengagement Intervention</condition>
  <arm_group>
    <arm_group_label>2nd level intervention: Rate Reduction</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Rate reduction intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2nd level intervention: Recycling</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Recycling Group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2nd level intervention: Choice</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Choice Group</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Rate reduction intervention</intervention_name>
    <arm_group_label>2nd level intervention: Rate Reduction</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Recycling Group</intervention_name>
    <arm_group_label>2nd level intervention: Recycling</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Choice Group</intervention_name>
    <arm_group_label>2nd level intervention: Choice</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Proactive QL</intervention_name>
    <arm_group_label>2nd level intervention: Choice</arm_group_label>
    <arm_group_label>2nd level intervention: Rate Reduction</arm_group_label>
    <arm_group_label>2nd level intervention: Recycling</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: To be included, individuals will be&#xD;
&#xD;
          -  Active Duty, Retired, or Dependent with Tricare benefits&#xD;
&#xD;
          -  Participants must be at least 18 years old&#xD;
&#xD;
          -  Smoked five or more cigarettes a day for at least one year&#xD;
&#xD;
          -  Live in the 48 contiguous states, Alaska or Hawaii&#xD;
&#xD;
          -  Participants must have the ability to understand consent procedures, and have access&#xD;
             to a telephone for participation&#xD;
&#xD;
          -  Seriously thinking of quitting smoking cigarettes in the next 30 days&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Persons who have a known or unknown knowledge of an allergy or hypersensitivity to&#xD;
             Nicotine Replacement Therapy (NRT)&#xD;
&#xD;
          -  Women who are pregnant, breastfeeding or planning to become pregnant during the next&#xD;
             12 months&#xD;
&#xD;
          -  Persons diagnosed with an unstable heart condition will be excluded as NRT is&#xD;
             contraindicated in these groups&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert Klesges, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UTHSC</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Wayne Talcott, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UTHSC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Wilford Hall Ambulatory Surgical Center</name>
      <address>
        <city>Lackland Air Force Base</city>
        <state>Texas</state>
        <zip>78236</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Little MA, Ebbert JO, Bursac Z, Talcott GW, Talley L, LeRoy KM, Womack CR, Hryshko-Mullen AS, Klesges RC. Enhancing the efficacy of a smoking quit line in the military: Study rationale, design and methods of the Freedom quit line. Contemp Clin Trials. 2017 Aug;59:51-56. doi: 10.1016/j.cct.2017.04.011. Epub 2017 May 4. No abstract available.</citation>
    <PMID>28479219</PMID>
  </reference>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>July 24, 2014</study_first_submitted>
  <study_first_submitted_qc>July 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 28, 2014</study_first_posted>
  <last_update_submitted>May 20, 2022</last_update_submitted>
  <last_update_submitted_qc>May 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 26, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Virginia</investigator_affiliation>
    <investigator_full_name>Melissa Little, PhD, MPH</investigator_full_name>
    <investigator_title>Associate Professor, Department of Public Health Sciences</investigator_title>
  </responsible_party>
  <keyword>smoking cessation</keyword>
  <keyword>quit line</keyword>
  <keyword>nicotine replacement therapy</keyword>
  <keyword>tobacco intervention</keyword>
  <!-- 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/NCT02201810
org study id: FWH20140076H
nct id: NCT02201810
lead sponsor: 
collaborator: 
has dmc: Yes
This study is a randomized clinical trial designed to measure the effectiveness of three QL
      interventions for smokers who failed to quit an initial smoking cessation intervention, but
      remain motivated to quit smoking.
In the investigators' previous QL protocol, FWH20080093H, the investigators documented that a
      military-tailored QL was associated with high rates of sustained smoking cessation. The
      proactive QL produced superior cessation rates at a one year follow-up compared to a reactive
      QL. Unfortunately, even with high rates of cessation, a large number of participants (the
      majority of participants) fail to remain quit at follow-up. Civilian QLs have observed the
      same marked decay of sustained cessation rates from the end of treatment to the one year
      follow-up.

      An opportunity exists to reengage these smokers who relapse or fail to quit by the end of QL
      treatment. Civilian QLs use one of two treatments, Recycling (repeat the smoking cessation
      counseling) or Rate Reduction (cut down over time), as the primary methods for treatment
      reengagement. Unfortunately, these methods of reengaging the relapsed/failed to quit smoker
      have not been systematically evaluated. As such, we propose to randomize participants who
      relapse or fail to quit by the end of the intervention to either (1) repeating the proactive
      QL (Recycle); (2) smoking reduction with the goal of eventual cessation (Rate Reduction); or
      (3) the choice of Recycle or Rate Reduction (Choice). Efficacy will be established by
      assessing both point prevalence and continuous abstinence at a 12 month follow-up.

      All participants (approximately 1900) are consented to follow-up treatment reengagement since
      we do not know a priori who will quit and who will not quit/relapse. The investigators
      anticipate, based on the investigators' QL study that about 30% will quit and remain quit
      based on the eight-week proactive QL and about 70% will either not quit or relapse (n≈1300).
      Those that are smoking at the three-month follow-up are stratified (based on whether they
      quit and relapsed vs. not quitting at all in the Proactive QL based upon self-report) and
      randomized to the three treatment reengagement strategies (Recycle, Rate Reduction, or
      Choice), each one lasting 8 weeks. Then, at one year follow-up, the investigators will assess
      both point prevalence and continuous abstinence. Since we are intervening on those that
      initially failed to quit or relapsed, continuous abstinence will be defined from the point of
      the last treatment reengagement intervention (one year from that point).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Effectiveness of randomized reengagement interventions
time frame: From 3 months follow up to 1 year follow up
description: We will assess tobacco status (both 7-day point prevalence and continuous abstinence) at the follow-up period (one year after reengagement interventions are completed) to assess outcome.
measure: One-year outcome from the initially successful group that quit smoking
time frame: 1-yr after initial randomization
arm group label: 2nd level intervention: Rate Reduction
arm group type: Experimental
description: Rate reduction intervention
arm group label: 2nd level intervention: Recycling
arm group type: Experimental
description: Recycling Group
arm group label: 2nd level intervention: Choice
arm group type: Experimental
description: Choice Group
intervention type: Behavioral
intervention name: Rate reduction intervention
arm group label: 2nd level intervention: Rate Reduction
intervention type: Behavioral
intervention name: Recycling Group
arm group label: 2nd level intervention: Recycling
intervention type: Behavioral
intervention name: Choice Group
arm group label: 2nd level intervention: Choice
intervention type: Behavioral
intervention name: Proactive QL
arm group label: 2nd level intervention: Choice
arm group label: 2nd level intervention: Rate Reduction
arm group label: 2nd level intervention: Recycling
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Robert Klesges, PhD
role: Principal Investigator
affiliation: UTHSC
last name: Wayne Talcott, PhD
role: Principal Investigator
affiliation: UTHSC
facility: 
country: United States
citation: Little MA, Ebbert JO, Bursac Z, Talcott GW, Talley L, LeRoy KM, Womack CR, Hryshko-Mullen AS, Klesges RC. Enhancing the efficacy of a smoking quit line in the military: Study rationale, design and methods of the Freedom quit line. Contemp Clin Trials. 2017 Aug;59:51-56. doi: 10.1016/j.cct.2017.04.011. Epub 2017 May 4. No abstract available.
PMID: 28479219
responsible party type: Principal Investigator
investigator affiliation: University of Virginia
investigator full name: Melissa Little, PhD, MPH
investigator title: Associate Professor, Department of Public Health Sciences