<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/NCT04487470</url>
  </required_header>
  <id_info>
    <org_study_id>19-202-2</org_study_id>
    <secondary_id>K01DA048494</secondary_id>
    <nct_id>NCT04487470</nct_id>
  </id_info>
  <brief_title>Impact of Cigar Flavor in Dual Users</brief_title>
  <official_title>Impact of Cigar Flavor on Tobacco Use Behaviors and Addiction in Dual Users</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>UConn Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Drug Abuse (NIDA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>UConn Health</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this remote study is to understand addiction to filtered cigars (FCs) compared&#xD;
      to cigarettes in young adults who are dual users of cigarettes and cigars, if flavor, such as&#xD;
      fruit or menthol, makes FCs more addictive, and if there are differences for men and women.&#xD;
      The first hypothesis is that the potential for FCs to cause addiction will be lower than that&#xD;
      of cigarettes, but will increase as cigarette cost increases. Second, flavored FCs will be&#xD;
      more addictive than unflavored FCs, and that the effect of flavored FCs on addiction will be&#xD;
      greater in women than men. Last, participants will smoke more FCs and fewer cigarettes when&#xD;
      given flavored compared to unflavored FCs. Prior to conducting the study, we will conduct a&#xD;
      pilot phase to test baseline procedures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this remote study is to understand addiction to filtered cigars (FCs) compared&#xD;
      to cigarettes in young adults who are dual users of cigarettes and cigars, if flavor, such as&#xD;
      fruit or menthol, makes FCs more addictive, and if there are differences for men and women.&#xD;
      The first hypothesis is that the potential for FCs to cause addiction will be lower than that&#xD;
      of cigarettes, but will increase as cigarette cost increases. Second, flavored FCs will be&#xD;
      more addictive than unflavored FCs, and that the effect of flavored FCs on addiction will be&#xD;
      greater in women than men. Last, participants will smoke more FCs and fewer cigarettes when&#xD;
      given flavored compared to unflavored FCs. This study employs a crossover design (controlled&#xD;
      for menthol status) in which 145 young adult dual users will be assigned a flavored or&#xD;
      unflavored FC and then switched to the other type after 1 week. We will utilize the Cigarette&#xD;
      Purchase Task, other standardized measures of dependence, and ecological momentary&#xD;
      assessments to study the relationship between dependence indicators and smoking in the&#xD;
      natural environment. All procedures will be conducted remotely by phone, computer, and mail.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 24, 2020</start_date>
  <completion_date type="Anticipated">May 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">May 31, 2024</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>Crossover Assignment</intervention_model>
    <intervention_model_description>Randomized cross-over study</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in demand elasticity for preferred flavored filtered cigars</measure>
    <time_frame>3-4 weeks</time_frame>
    <description>It is measured by the Cigarette Purchase Task, which will be adapted to assess these products. It is the hypothetical consumption of flavored cigars at increasing prices.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in demand elasticity for preferred unflavored filtered cigars</measure>
    <time_frame>3-4 weeks</time_frame>
    <description>It is measured by the Cigarette Purchase Task, which will be adapted to assess these products. It is the hypothetical consumption of unflavored cigars at increasing prices.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in cross price elasticity for filtered cigars and cigarettes</measure>
    <time_frame>3-4 weeks</time_frame>
    <description>It is measured by the Cross-Price Purchase Task. It is the hypothetical consumption of flavored and unflavored filtered cigars as cigarette prices increase.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in exhaled breath carbon monoxide (CO) level</measure>
    <time_frame>3-4 weeks</time_frame>
    <description>Daily exhaled breath CO measured over the course of the study period</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in saliva cotinine levels</measure>
    <time_frame>3-4 weeks</time_frame>
    <description>Saliva samples will be analyzed for cotinine levels</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in number of flavored cigars, unflavored cigars, and cigarettes smoked per day</measure>
    <time_frame>3-4 weeks</time_frame>
    <description>Participants will record tobacco use daily on their mobile phones using an app.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">145</enrollment>
  <condition>Tobacco Use Disorder</condition>
  <arm_group>
    <arm_group_label>Flavored Filtered Cigars</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Half of the group will be randomized to start with flavored filtered cigars (FCs) at the second visit and cross over to unflavored FCs at the third visit. FCs will be Cheyenne filtered cigars.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Unflavored Filtered Cigars</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Half of the group will be randomized to start with unflavored FCs at the second visit and cross over to flavored FCs at the third visit. FCs will be Cheyenne filtered cigars.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Flavored filtered cigars</intervention_name>
    <description>Flavored and unflavored Cheyenne filtered cigars that are currently available in the marketplace for purchase</description>
    <arm_group_label>Flavored Filtered Cigars</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Unflavored filtered cigars</intervention_name>
    <description>Flavored and unflavored Cheyenne filtered cigars that are currently available in the marketplace for purchase</description>
    <arm_group_label>Unflavored Filtered Cigars</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Current regular dual uses of filtered cigars and cigarillos (FCs) and cigarettes&#xD;
             defined as; (a) report smoking cigarettes at least weekly in the past 30 days, (b)&#xD;
             report smoking unaltered FC (without marijuana) at least weekly in the past 30 days;&#xD;
             and (c)report cigarette and cigar use at their current rate (or more frequently) for ≥&#xD;
             3 months.&#xD;
&#xD;
          -  Able to read, speak, and understand English&#xD;
&#xD;
          -  Age 18-34 years&#xD;
&#xD;
          -  Stable residence (does not intend to move during the study period)&#xD;
&#xD;
          -  Not intending to quit smoking during the study period&#xD;
&#xD;
          -  Has a smart phone with a data plan (this study is being done remotely)&#xD;
&#xD;
          -  Saliva cotinine level &gt;30 ng/mL&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Self-reported current pregnancy, currently trying to become pregnant, or&#xD;
             breast-feeding&#xD;
&#xD;
          -  Current use of nicotine replacement products or cessation products (e.g., bupropion)&#xD;
             or plans to use in the next 3 weeks for the purposes of cessation&#xD;
&#xD;
          -  Diagnosed with or being treated for COPD, emphysema, and/or uncontrolled asthma as&#xD;
             determined by research screening&#xD;
&#xD;
          -  Currently taking anti-hypertensive medications&#xD;
&#xD;
          -  Currently has pneumonia, bronchitis, or COVID symptoms that has not yet resolved, or&#xD;
             was hospitalized or visited the ER in the past 4 weeks for a respiratory-related&#xD;
             illness that has not yet resolved (can be re-screened once resolved)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>34 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Erin Mead, PhD,MHS</last_name>
    <role>Principal Investigator</role>
    <affiliation>UConn Health</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Catherine Jahne, RN,BSN,RA 3</last_name>
    <phone>(860)305-3061</phone>
    <email>jahne@uchc.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Erin Mead, PhD,MHS</last_name>
    <phone>(860)679-2456</phone>
    <email>mead@uchc.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>UConn Health</name>
      <address>
        <city>Farmington</city>
        <state>Connecticut</state>
        <zip>06030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Catherine A Jahne, BSN</last_name>
      <phone>860-679-1138</phone>
      <email>jahne@uchc.edu</email>
    </contact>
    <contact_backup>
      <last_name>Erin L Mead, PhD,MHS</last_name>
      <phone>860-679-2456</phone>
      <email>mead@uchc.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>May 12, 2022</last_update_submitted>
  <last_update_submitted_qc>May 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 13, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>UConn Health</investigator_affiliation>
    <investigator_full_name>Erin Mead-Morse</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Dual Tobacco Use</keyword>
  <keyword>Smoking</keyword>
  <keyword>Cigar Smoking</keyword>
  <keyword>Cigarette Smoking</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tobacco Use Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>A verified database will be available once the main findings from the final dataset have been reported and accepted for publication. Information that does result from our analysis of the urine samples will be available after publication of the findings. De-identified dataset will contain the data merged from all study visits. We will include with the data file proper documentation of all data (including definitions of variables and derived variables, frequencies, details about codes, etc.), and procedures used to collect the data, to ensure others can use the dataset and to prevent misuse, misinterpretation, and/or confusion. The database intended for public distribution will be free of identifiers that would permit linkages to individual research participants and variables that could lead to deductive disclosure of the identity of individual subjects.</ipd_description>
    <ipd_time_frame>In the final year of the Award after the dataset is finalized we will prepare a file in Excel and Stata that contains all study variables intended for use in presentations and publications.</ipd_time_frame>
  </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/NCT04487470
org study id: 19-202-2
secondary id: K01DA048494
nct id: NCT04487470
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this remote study is to understand addiction to filtered cigars (FCs) compared
      to cigarettes in young adults who are dual users of cigarettes and cigars, if flavor, such as
      fruit or menthol, makes FCs more addictive, and if there are differences for men and women.
      The first hypothesis is that the potential for FCs to cause addiction will be lower than that
      of cigarettes, but will increase as cigarette cost increases. Second, flavored FCs will be
      more addictive than unflavored FCs, and that the effect of flavored FCs on addiction will be
      greater in women than men. Last, participants will smoke more FCs and fewer cigarettes when
      given flavored compared to unflavored FCs. Prior to conducting the study, we will conduct a
      pilot phase to test baseline procedures.
The purpose of this remote study is to understand addiction to filtered cigars (FCs) compared
      to cigarettes in young adults who are dual users of cigarettes and cigars, if flavor, such as
      fruit or menthol, makes FCs more addictive, and if there are differences for men and women.
      The first hypothesis is that the potential for FCs to cause addiction will be lower than that
      of cigarettes, but will increase as cigarette cost increases. Second, flavored FCs will be
      more addictive than unflavored FCs, and that the effect of flavored FCs on addiction will be
      greater in women than men. Last, participants will smoke more FCs and fewer cigarettes when
      given flavored compared to unflavored FCs. This study employs a crossover design (controlled
      for menthol status) in which 145 young adult dual users will be assigned a flavored or
      unflavored FC and then switched to the other type after 1 week. We will utilize the Cigarette
      Purchase Task, other standardized measures of dependence, and ecological momentary
      assessments to study the relationship between dependence indicators and smoking in the
      natural environment. All procedures will be conducted remotely by phone, computer, and mail.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Randomized cross-over study
primary purpose: Other
masking: None (Open Label)
measure: Change in demand elasticity for preferred flavored filtered cigars
time frame: 3-4 weeks
description: It is measured by the Cigarette Purchase Task, which will be adapted to assess these products. It is the hypothetical consumption of flavored cigars at increasing prices.
measure: Change in demand elasticity for preferred unflavored filtered cigars
time frame: 3-4 weeks
description: It is measured by the Cigarette Purchase Task, which will be adapted to assess these products. It is the hypothetical consumption of unflavored cigars at increasing prices.
measure: Change in cross price elasticity for filtered cigars and cigarettes
time frame: 3-4 weeks
description: It is measured by the Cross-Price Purchase Task. It is the hypothetical consumption of flavored and unflavored filtered cigars as cigarette prices increase.
measure: Change in exhaled breath carbon monoxide (CO) level
time frame: 3-4 weeks
description: Daily exhaled breath CO measured over the course of the study period
measure: Change in saliva cotinine levels
time frame: 3-4 weeks
description: Saliva samples will be analyzed for cotinine levels
measure: Change in number of flavored cigars, unflavored cigars, and cigarettes smoked per day
time frame: 3-4 weeks
description: Participants will record tobacco use daily on their mobile phones using an app.
arm group label: Flavored Filtered Cigars
arm group type: Experimental
description: Half of the group will be randomized to start with flavored filtered cigars (FCs) at the second visit and cross over to unflavored FCs at the third visit. FCs will be Cheyenne filtered cigars.
arm group label: Unflavored Filtered Cigars
arm group type: Experimental
description: Half of the group will be randomized to start with unflavored FCs at the second visit and cross over to flavored FCs at the third visit. FCs will be Cheyenne filtered cigars.
intervention type: Other
intervention name: Flavored filtered cigars
description: Flavored and unflavored Cheyenne filtered cigars that are currently available in the marketplace for purchase
arm group label: Flavored Filtered Cigars
intervention type: Other
intervention name: Unflavored filtered cigars
description: Flavored and unflavored Cheyenne filtered cigars that are currently available in the marketplace for purchase
arm group label: Unflavored Filtered Cigars
criteria: 
gender: All
minimum age: 18 Years
maximum age: 34 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Erin Mead, PhD,MHS
role: Principal Investigator
affiliation: UConn Health
last name: Catherine Jahne, RN,BSN,RA 3
phone: (860)305-3061
email: jahne@uchc.edu
last name: Erin Mead, PhD,MHS
phone: (860)679-2456
email: mead@uchc.edu
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: UConn Health
investigator full name: Erin Mead-Morse
investigator title: Assistant Professor
mesh term: Tobacco Use Disorder
sharing ipd: Yes
ipd description: A verified database will be available once the main findings from the final dataset have been reported and accepted for publication. Information that does result from our analysis of the urine samples will be available after publication of the findings. De-identified dataset will contain the data merged from all study visits. We will include with the data file proper documentation of all data (including definitions of variables and derived variables, frequencies, details about codes, etc.), and procedures used to collect the data, to ensure others can use the dataset and to prevent misuse, misinterpretation, and/or confusion. The database intended for public distribution will be free of identifiers that would permit linkages to individual research participants and variables that could lead to deductive disclosure of the identity of individual subjects.
ipd time frame: In the final year of the Award after the dataset is finalized we will prepare a file in Excel and Stata that contains all study variables intended for use in presentations and publications.