<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/NCT03290430</url>
  </required_header>
  <id_info>
    <org_study_id>CASE3Z17</org_study_id>
    <nct_id>NCT03290430</nct_id>
  </id_info>
  <brief_title>End Nicotine Dependence Clinic</brief_title>
  <official_title>End Nicotine Dependence (END) Clinic</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Case Comprehensive Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Case Comprehensive Cancer 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>
      The purpose of this research is to study a smoking cessation program for adult smokers in&#xD;
      Northeast Ohio. The study will also look at how different people respond to the program.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective 1: To examine the feasibility of conducting an evidence-based, cognitive behavioral&#xD;
      therapy (CBT) for tobacco cessation delivered in multiple formats. Participants will have the&#xD;
      opportunity to receive a CBT-based tobacco intervention delivered several possible formats&#xD;
      (face-to-face, telephone, video-counseling) based on availability and participant&#xD;
      preferences. Study participants will be exposed to cognitive-behavioral cessation and relapse&#xD;
      prevention strategies, and discuss barriers to cessation, previous quit attempts, risky&#xD;
      situations, and benefits observed after quitting. Participants may also complete exercises&#xD;
      designed to assist cessation attempts (e.g., mental and behavioral coping skills, cognitive&#xD;
      reframing exercise, health benefits of cessation; and no-smoking behavioral contracts). As&#xD;
      supplemental treatment, participants may have the option to receive up to 8 weeks of nicotine&#xD;
      replacement therapy and text-messaging support.&#xD;
&#xD;
      Objective 2: To examine the rates of smoking abstinence across intervention formats.&#xD;
      Investigators will attempt to follow-up with participants for a 6-months after program&#xD;
      completion. Investigators will assess point prevalence abstinence for each intervention&#xD;
      delivery method.&#xD;
&#xD;
      Objective 3: To assess individual difference variables that influence outcomes. Investigators&#xD;
      will examine individual-difference predictors of outcomes, such as readiness to quit, social&#xD;
      support, distress, and environmental factors.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 9, 2018</start_date>
  <completion_date type="Actual">January 6, 2020</completion_date>
  <primary_completion_date type="Actual">December 6, 2019</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>this is a quasi-experiment, with 4 intervention arms plus options for supplemental intervention support</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of 24 hour smoking abstinence across intervention</measure>
    <time_frame>Up to 24 hours after session 1</time_frame>
    <description>Number of participants who did not smoke for 24 hours. Coded as binary (1 = cessation, 0 = smoking)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of 7-day smoking abstinence across intervention</measure>
    <time_frame>Up to 7 days after session 1</time_frame>
    <description>Number of participants who did not smoke for 7 days (1 = cessation, 0 = smoking)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of 28-day smoking abstinence across intervention</measure>
    <time_frame>Up to 28 days after session 1</time_frame>
    <description>Number of participants who did not smoke for 28 days (1 = cessation, 0 = smoking)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average intervention rating</measure>
    <time_frame>Up to 4 weeks after session 1</time_frame>
    <description>Scaled survey will be used to assess the quality and the content of the intervention [i.e., the extent to which the content was informative, encouraging, attention capturing, credible, applicable to their lives, and comprehensible.]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sessions completed</measure>
    <time_frame>Up to 4 weeks after session 1</time_frame>
    <description>Average count of sessions each participant completed (1-8)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Study Retention</measure>
    <time_frame>Up to 4 weeks after session 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nicotine Replacement Therapy (NRT) Completed</measure>
    <time_frame>Up to 4 weeks after session 1</time_frame>
    <description>Average count of doses of NRT taken by participants</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">56</enrollment>
  <condition>Smoking Cessation</condition>
  <arm_group>
    <arm_group_label>Group Counseling</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be asked to complete a set of surveys that should take about 30 minutes to finish. The surveys will ask questions about the participant, their health history, their desire to quit smoking, and their beliefs and attitudes. There will be 8 sessions over 4 week, each lasting between 1-2 hours. During these sessions, participants will learn about how to quit smoking by changing habits. Sessions may be audio or video taped.&#xD;
The study team will use text messaging as a way to keep in contact with all participants. Participants will have the option of getting text-based support throughout the program no matter which session format they chose. Subjects will receive up to 8 weeks of nicotine replacement therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Individual Counseling</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be asked to complete a set of surveys that should take about 30 minutes to finish. The surveys will ask questions about the participant, their health history, their desire to quit smoking, and their beliefs and attitudes. There will be 8 sessions over 4 week, each lasting between 30-45 minutes. During these sessions, participants will learn about how to quit smoking by changing habits. Sessions may be audio or video taped.&#xD;
The study team will use text messaging as a way to keep in contact with all participants. Participants will have the option of getting text-based support throughout the program no matter which session format they chose. Subjects will receive up to 8 weeks of nicotine replacement therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Telephone Counseling</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be asked to complete a set of surveys that should take about 30 minutes to finish. The surveys will ask questions about the participant, their health history, their desire to quit smoking, and their beliefs and attitudes. There will be 8 phone calls over 4 week, each lasting between 30-45 minutes. During these phone calls, participants will learn about how to quit smoking by changing habits. Sessions may be audio taped.&#xD;
The study team will use text messaging as a way to keep in contact with all participants. Participants will have the option of getting text-based support throughout the program no matter which session format they chose. Subjects will receive up to 8 weeks of nicotine replacement therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Video Counseling</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be asked to complete a set of surveys that should take about 30 minutes to finish. The surveys will ask questions about the participant, their health history, their desire to quit smoking, and their beliefs and attitudes. There will be 8 video calls over 4 week, each lasting between 30-45 minutes. During these video calls, participants will learn about how to quit smoking by changing habits. Sessions may be recorded.&#xD;
The study team will use text messaging as a way to keep in contact with all participants. Participants will have the option of getting text-based support throughout the program no matter which session format they chose. Subjects will receive up to 8 weeks of nicotine replacement therapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Group Counseling</intervention_name>
    <description>8 sessions over 4 weeks. Lasting 1-2 hours each</description>
    <arm_group_label>Group Counseling</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Individual Counseling</intervention_name>
    <description>8 in person sessions over 4 weeks. Lasting 30-45 minutes each</description>
    <arm_group_label>Individual Counseling</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Phone Counseling</intervention_name>
    <description>8 phone sessions over 4 weeks. Lasting 30-45 minutes each</description>
    <arm_group_label>Telephone Counseling</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Video Counseling</intervention_name>
    <description>8 video call sessions over 4 weeks. Lasting 30-45 minutes each</description>
    <arm_group_label>Video Counseling</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Texting support</intervention_name>
    <description>Texts with smoking cessation support throughout the program</description>
    <arm_group_label>Group Counseling</arm_group_label>
    <arm_group_label>Individual Counseling</arm_group_label>
    <arm_group_label>Telephone Counseling</arm_group_label>
    <arm_group_label>Video Counseling</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nicotine Replacement Therapy</intervention_name>
    <description>Participants will receive up to 8 weeks of over-the-counter nicotine replacement therapy</description>
    <arm_group_label>Group Counseling</arm_group_label>
    <arm_group_label>Individual Counseling</arm_group_label>
    <arm_group_label>Telephone Counseling</arm_group_label>
    <arm_group_label>Video Counseling</arm_group_label>
    <other_name>Nicotine Patch</other_name>
    <other_name>Nicotine Gum</other_name>
    <other_name>NRT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Current smokers who would like help quitting (≥ 5 cigarettes per day and/or have a&#xD;
             breath carbon monoxide (CO) reading of ≥ 8 ppm)&#xD;
&#xD;
          -  Able to speak and read English&#xD;
&#xD;
          -  Able to engage using at least one of the intervention formats.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Enrollment in another cessation program&#xD;
&#xD;
          -  Do not speak and read English&#xD;
&#xD;
          -  Do not have access to at least one intervention format&#xD;
&#xD;
          -  Have contraindications for NRT&#xD;
&#xD;
          -  Do not have contact information (e.g., address, telephone number)&#xD;
&#xD;
          -  Are in treatment for substance abuse (e.g., illicit drugs, alcohol abuse)&#xD;
&#xD;
          -  They endorse active addiction to another substance (e.g., illicit drugs or alcohol).&#xD;
&#xD;
          -  People who self-report having a severe mental illness&#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>Monica Webb Hooper, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Case Comprehensive Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Case Western Reserve University, Case Comprehensive Cancer Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>September 19, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 21, 2017</study_first_posted>
  <last_update_submitted>April 10, 2020</last_update_submitted>
  <last_update_submitted_qc>April 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Nicotine Dependence</keyword>
  <keyword>applied behavioral research</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>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/NCT03290430
org study id: CASE3Z17
nct id: NCT03290430
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The purpose of this research is to study a smoking cessation program for adult smokers in
      Northeast Ohio. The study will also look at how different people respond to the program.
Objective 1: To examine the feasibility of conducting an evidence-based, cognitive behavioral
      therapy (CBT) for tobacco cessation delivered in multiple formats. Participants will have the
      opportunity to receive a CBT-based tobacco intervention delivered several possible formats
      (face-to-face, telephone, video-counseling) based on availability and participant
      preferences. Study participants will be exposed to cognitive-behavioral cessation and relapse
      prevention strategies, and discuss barriers to cessation, previous quit attempts, risky
      situations, and benefits observed after quitting. Participants may also complete exercises
      designed to assist cessation attempts (e.g., mental and behavioral coping skills, cognitive
      reframing exercise, health benefits of cessation; and no-smoking behavioral contracts). As
      supplemental treatment, participants may have the option to receive up to 8 weeks of nicotine
      replacement therapy and text-messaging support.

      Objective 2: To examine the rates of smoking abstinence across intervention formats.
      Investigators will attempt to follow-up with participants for a 6-months after program
      completion. Investigators will assess point prevalence abstinence for each intervention
      delivery method.

      Objective 3: To assess individual difference variables that influence outcomes. Investigators
      will examine individual-difference predictors of outcomes, such as readiness to quit, social
      support, distress, and environmental factors.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: this is a quasi-experiment, with 4 intervention arms plus options for supplemental intervention support
primary purpose: Supportive Care
masking: None (Open Label)
measure: Rate of 24 hour smoking abstinence across intervention
time frame: Up to 24 hours after session 1
description: Number of participants who did not smoke for 24 hours. Coded as binary (1 = cessation, 0 = smoking)
measure: Rate of 7-day smoking abstinence across intervention
time frame: Up to 7 days after session 1
description: Number of participants who did not smoke for 7 days (1 = cessation, 0 = smoking)
measure: Rate of 28-day smoking abstinence across intervention
time frame: Up to 28 days after session 1
description: Number of participants who did not smoke for 28 days (1 = cessation, 0 = smoking)
measure: Average intervention rating
time frame: Up to 4 weeks after session 1
description: Scaled survey will be used to assess the quality and the content of the intervention [i.e., the extent to which the content was informative, encouraging, attention capturing, credible, applicable to their lives, and comprehensible.]
measure: Sessions completed
time frame: Up to 4 weeks after session 1
description: Average count of sessions each participant completed (1-8)
measure: Study Retention
time frame: Up to 4 weeks after session 1
measure: Nicotine Replacement Therapy (NRT) Completed
time frame: Up to 4 weeks after session 1
description: Average count of doses of NRT taken by participants
arm group label: Group Counseling
arm group type: Experimental
description: Participants will be asked to complete a set of surveys that should take about 30 minutes to finish. The surveys will ask questions about the participant, their health history, their desire to quit smoking, and their beliefs and attitudes. There will be 8 sessions over 4 week, each lasting between 1-2 hours. During these sessions, participants will learn about how to quit smoking by changing habits. Sessions may be audio or video taped.
The study team will use text messaging as a way to keep in contact with all participants. Participants will have the option of getting text-based support throughout the program no matter which session format they chose. Subjects will receive up to 8 weeks of nicotine replacement therapy.
arm group label: Individual Counseling
arm group type: Experimental
description: Participants will be asked to complete a set of surveys that should take about 30 minutes to finish. The surveys will ask questions about the participant, their health history, their desire to quit smoking, and their beliefs and attitudes. There will be 8 sessions over 4 week, each lasting between 30-45 minutes. During these sessions, participants will learn about how to quit smoking by changing habits. Sessions may be audio or video taped.
The study team will use text messaging as a way to keep in contact with all participants. Participants will have the option of getting text-based support throughout the program no matter which session format they chose. Subjects will receive up to 8 weeks of nicotine replacement therapy.
arm group label: Telephone Counseling
arm group type: Experimental
description: Participants will be asked to complete a set of surveys that should take about 30 minutes to finish. The surveys will ask questions about the participant, their health history, their desire to quit smoking, and their beliefs and attitudes. There will be 8 phone calls over 4 week, each lasting between 30-45 minutes. During these phone calls, participants will learn about how to quit smoking by changing habits. Sessions may be audio taped.
The study team will use text messaging as a way to keep in contact with all participants. Participants will have the option of getting text-based support throughout the program no matter which session format they chose. Subjects will receive up to 8 weeks of nicotine replacement therapy.
arm group label: Video Counseling
arm group type: Experimental
description: Participants will be asked to complete a set of surveys that should take about 30 minutes to finish. The surveys will ask questions about the participant, their health history, their desire to quit smoking, and their beliefs and attitudes. There will be 8 video calls over 4 week, each lasting between 30-45 minutes. During these video calls, participants will learn about how to quit smoking by changing habits. Sessions may be recorded.
The study team will use text messaging as a way to keep in contact with all participants. Participants will have the option of getting text-based support throughout the program no matter which session format they chose. Subjects will receive up to 8 weeks of nicotine replacement therapy.
intervention type: Behavioral
intervention name: Group Counseling
description: 8 sessions over 4 weeks. Lasting 1-2 hours each
arm group label: Group Counseling
intervention type: Behavioral
intervention name: Individual Counseling
description: 8 in person sessions over 4 weeks. Lasting 30-45 minutes each
arm group label: Individual Counseling
intervention type: Behavioral
intervention name: Phone Counseling
description: 8 phone sessions over 4 weeks. Lasting 30-45 minutes each
arm group label: Telephone Counseling
intervention type: Behavioral
intervention name: Video Counseling
description: 8 video call sessions over 4 weeks. Lasting 30-45 minutes each
arm group label: Video Counseling
intervention type: Behavioral
intervention name: Texting support
description: Texts with smoking cessation support throughout the program
arm group label: Group Counseling
arm group label: Individual Counseling
arm group label: Telephone Counseling
arm group label: Video Counseling
intervention type: Drug
intervention name: Nicotine Replacement Therapy
description: Participants will receive up to 8 weeks of over-the-counter nicotine replacement therapy
arm group label: Group Counseling
arm group label: Individual Counseling
arm group label: Telephone Counseling
arm group label: Video Counseling
other name: Nicotine Patch
other name: Nicotine Gum
other name: NRT
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Monica Webb Hooper, PhD
role: Principal Investigator
affiliation: Case Comprehensive Cancer Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Tobacco Use Disorder
mesh term: Nicotine