<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/NCT03277495</url>
  </required_header>
  <id_info>
    <org_study_id>2017-0948</org_study_id>
    <secondary_id>1U01DA045524-01</secondary_id>
    <nct_id>NCT03277495</nct_id>
  </id_info>
  <brief_title>Predictors and Consequences of Combustible Cigarette Smokers' Switch to Standardized Research E-Cigarettes</brief_title>
  <official_title>Predictors and Consequences of Combustible Cigarette Smokers' Switch to Standardized Research E-Cigarettes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Illinois at Chicago</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Drug Abuse (NIDA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Chicago</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Illinois at Chicago</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary goal of this study is to examine whether cigarette smokers can reduce their use&#xD;
      of conventional, combustible cigarettes by switching to a Standardized Research E-Cigarette&#xD;
      (SREC); whether participants can maintain these reductions and use of SRECs over a 12-week&#xD;
      period; and whether there are changes in subjective and objective measures of health, appeal&#xD;
      and acceptability of the products used during this time frame.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will enroll 120 conventional cigarette smokers who report smoking at least&#xD;
      3 cigarettes/day. Following completion of baseline questionnaires and a week of ecological&#xD;
      momentary assessments (EMA) tracking participants usual smoking behavior, participants will&#xD;
      be stratified (by sex) and randomly assigned with a 1:1 allocation ratio to one of two&#xD;
      conditions: 1) to receive SREC pods in their usual flavor (N = 60); and 2) to receive SREC&#xD;
      pods in their choice of flavor (N = 60). The SREC pods used in this study come in tobacco,&#xD;
      menthol, blueberry, and watermelon flavors. No other flavors will be available to use with&#xD;
      the SREC.&#xD;
&#xD;
      Counseling at Week 2. Participants in both conditions will receive brief behavioral&#xD;
      counseling on reducing their combustible cigarette use by substitution with SREC. Staff will&#xD;
      work with participants to set individual goals for reduction during this first week, with the&#xD;
      goal of achieving at least 75% reduction in the number of combustible cigarettes smoked by&#xD;
      the end of the week, and all are encouraged to reduce further. Participants will also be told&#xD;
      not to use any other combustible tobacco products. During the week, participants will&#xD;
      complete a daily text or web report on number of cigarettes smoked and SREC pods used.&#xD;
&#xD;
      Week 3 Visit. Participants will bring back all used and unused pods for adherence counts,&#xD;
      complete a brief questionnaire about subjective reactions and potential adverse effects, and&#xD;
      provide breath CO. Participants will meet with study staff to review their progress with&#xD;
      switching to SREC and receive continued behavioral counseling to substitute SREC for&#xD;
      cigarettes. Participants will receive SREC refill pods and will start a second 7-day EMA&#xD;
      protocol.&#xD;
&#xD;
      Week 4 Visit. EMA debriefing to check for compliance and any problem reports; return of used&#xD;
      and unused pods, complete assessments; review of progress with switching to SREC.&#xD;
      Participants will receive a 2 week supply of SREC pods.&#xD;
&#xD;
      Weeks 5-13. Participants return to the study office every 2 weeks to return pods, receive a&#xD;
      new supply, and provide breath CO. During the week, participants will continue daily use&#xD;
      reports via web/text.&#xD;
&#xD;
      Week 14 (End-of-Treatment). Participants return to the study office to complete a full&#xD;
      assessment battery. They will be encouraged to continue to stay off/reduce all combustible&#xD;
      cigarettes, but will not receive additional SREC refills from the study.&#xD;
&#xD;
      Week 18 (One Month Follow-up). Participants complete a final survey.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 12, 2023</start_date>
  <completion_date type="Anticipated">August 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">April 1, 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>Parallel Assignment</intervention_model>
    <intervention_model_description>Participants will be stratified by sex and randomly assigned with a 1:1 allocation ratio to one of two conditions: 1) to receive SREC pods in their usual flavor (N = 60); and 2) to receive SREC pods in their choice of flavor (N = 60).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Combustible cigarette use</measure>
    <time_frame>12-weeks (end of treatment)</time_frame>
    <description>number of cigarettes smoked per week</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Abstinence</measure>
    <time_frame>12-weeks (end of treatment)</time_frame>
    <description>The proportion of participants who achieve total abstinence from combustible cigarettes (defined as no cigarette smoking in the past 7 days)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of cigarettes smoked</measure>
    <time_frame>18-weeks (end of trial)</time_frame>
    <description>The total number of cigarettes smoked in the 7 days prior to the last assessment</description>
  </secondary_outcome>
  <other_outcome>
    <measure>CO level</measure>
    <time_frame>12-weeks</time_frame>
    <description>in ppm</description>
  </other_outcome>
  <other_outcome>
    <measure>Blood Pressure</measure>
    <time_frame>12-weeks</time_frame>
    <description>systolic blood pressure and diastolic blood pressure in mm hg</description>
  </other_outcome>
  <other_outcome>
    <measure>Heart Rate</measure>
    <time_frame>12-weeks</time_frame>
    <description>beats per minute</description>
  </other_outcome>
  <other_outcome>
    <measure>Weight</measure>
    <time_frame>12-weeks</time_frame>
    <description>in pounds</description>
  </other_outcome>
  <other_outcome>
    <measure>self-report of respiratory symptoms</measure>
    <time_frame>12-weeks</time_frame>
    <description>The St. George's Respiratory Questionnaire (SGRQ)</description>
  </other_outcome>
  <other_outcome>
    <measure>nicotine dependence</measure>
    <time_frame>12-weeks</time_frame>
    <description>Fagerstrom Test for Nicotine Dependence</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Tobacco Use</condition>
  <arm_group>
    <arm_group_label>Usual SREC pods Flavor</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The liquid in the e-cigarette refills contains nicotine and comes in the following flavors: tobacco, menthol, blueberry, and watermelon. The participant will receive SREC pods in their usual flavor.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Choice of SREC pods Flavors</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The liquid in the e-cigarette refills contains nicotine and comes in the following flavors: tobacco, menthol, blueberry, and watermelon. The participant will receive SREC pods in their choice of flavor.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Brief behavioral counseling</intervention_name>
    <description>Staff will engage in behavioral counseling to identify strategies for reducing combustible cigarette use. All participants in the trial receive this intervention</description>
    <arm_group_label>Choice of SREC pods Flavors</arm_group_label>
    <arm_group_label>Usual SREC pods Flavor</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. men and women 21 years of age or older;&#xD;
&#xD;
          2. daily smoking rate of 3 cigarettes/day or greater for at least one year;&#xD;
&#xD;
          3. interested in reducing cigarette use;&#xD;
&#xD;
          4. willing to try e-cigarettes;&#xD;
&#xD;
          5. able to attend in-person assessments over the next 5 months;&#xD;
&#xD;
          6. English speaking; and&#xD;
&#xD;
          7. breath CO of 3ppm or greater (assessed at baseline visit). Women who are of&#xD;
             child-bearing age cannot be pregnant and must agree to use an approved form of birth&#xD;
             control during the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. current use of any smoking cessation medication or participation in a smoking&#xD;
             cessation program or study;&#xD;
&#xD;
          2. current daily ENDS user;&#xD;
&#xD;
          3. pregnancy if female; and&#xD;
&#xD;
          4. no two members of the same household may participate in this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robin Mermelstein, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Illinois at Chicago</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kathleen Diviak, PhD</last_name>
    <phone>312-996-2327</phone>
    <email>kdiviak@uic.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Institute for Health Research and Policy</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60608</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kathleen Diviak, PhD</last_name>
      <phone>312-996-2327</phone>
      <email>kdiviak@uic.edu</email>
    </contact>
    <investigator>
      <last_name>Robin Mermelstein, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>September 7, 2017</study_first_submitted>
  <study_first_submitted_qc>September 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</study_first_posted>
  <last_update_submitted>August 2, 2023</last_update_submitted>
  <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Illinois at Chicago</investigator_affiliation>
    <investigator_full_name>Robin Mermelstein</investigator_full_name>
    <investigator_title>Distinguished Professor and Director</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Within two years after the final data collection is completed, the investigators will create a completely de-identified data set will that obfuscate any variable that might potentially be used to identify an individual study participant. Data collection instruments, codebooks, and other data documentation will be made available in conjunction with this dataset in a standard format that is readable across a variety of applications and operating system platforms.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Data will become available no later than two years after the final data collection is completed. There is no time frame identified for stopping the sharing of the data.</ipd_time_frame>
    <ipd_access_criteria>A data sharing agreement will be required for release of any data. Individuals requesting a copy of study data will need to submit a detailed research plan that includes the purpose of the proposed research, the variables required, the duration of the analysis phase, IRB approval with FWA information, investigator training in human subjects and other approvals specific to the individual datasets. They will also be required to submit a Data Protection Plan or Institutional Privacy Policy, describing the computing environment in which data will be managed and analyzed and how physical access to computing equipment will be controlled. Data will only be released once all IRB approvals and Human Subjects concerns have been addressed.</ipd_access_criteria>
  </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/NCT03277495
org study id: 2017-0948
secondary id: 1U01DA045524-01
nct id: NCT03277495
lead sponsor: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The primary goal of this study is to examine whether cigarette smokers can reduce their use
      of conventional, combustible cigarettes by switching to a Standardized Research E-Cigarette
      (SREC); whether participants can maintain these reductions and use of SRECs over a 12-week
      period; and whether there are changes in subjective and objective measures of health, appeal
      and acceptability of the products used during this time frame.
The investigators will enroll 120 conventional cigarette smokers who report smoking at least
      3 cigarettes/day. Following completion of baseline questionnaires and a week of ecological
      momentary assessments (EMA) tracking participants usual smoking behavior, participants will
      be stratified (by sex) and randomly assigned with a 1:1 allocation ratio to one of two
      conditions: 1) to receive SREC pods in their usual flavor (N = 60); and 2) to receive SREC
      pods in their choice of flavor (N = 60). The SREC pods used in this study come in tobacco,
      menthol, blueberry, and watermelon flavors. No other flavors will be available to use with
      the SREC.

      Counseling at Week 2. Participants in both conditions will receive brief behavioral
      counseling on reducing their combustible cigarette use by substitution with SREC. Staff will
      work with participants to set individual goals for reduction during this first week, with the
      goal of achieving at least 75% reduction in the number of combustible cigarettes smoked by
      the end of the week, and all are encouraged to reduce further. Participants will also be told
      not to use any other combustible tobacco products. During the week, participants will
      complete a daily text or web report on number of cigarettes smoked and SREC pods used.

      Week 3 Visit. Participants will bring back all used and unused pods for adherence counts,
      complete a brief questionnaire about subjective reactions and potential adverse effects, and
      provide breath CO. Participants will meet with study staff to review their progress with
      switching to SREC and receive continued behavioral counseling to substitute SREC for
      cigarettes. Participants will receive SREC refill pods and will start a second 7-day EMA
      protocol.

      Week 4 Visit. EMA debriefing to check for compliance and any problem reports; return of used
      and unused pods, complete assessments; review of progress with switching to SREC.
      Participants will receive a 2 week supply of SREC pods.

      Weeks 5-13. Participants return to the study office every 2 weeks to return pods, receive a
      new supply, and provide breath CO. During the week, participants will continue daily use
      reports via web/text.

      Week 14 (End-of-Treatment). Participants return to the study office to complete a full
      assessment battery. They will be encouraged to continue to stay off/reduce all combustible
      cigarettes, but will not receive additional SREC refills from the study.

      Week 18 (One Month Follow-up). Participants complete a final survey.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants will be stratified by sex and randomly assigned with a 1:1 allocation ratio to one of two conditions: 1) to receive SREC pods in their usual flavor (N = 60); and 2) to receive SREC pods in their choice of flavor (N = 60).
primary purpose: Treatment
masking: None (Open Label)
measure: Combustible cigarette use
time frame: 12-weeks (end of treatment)
description: number of cigarettes smoked per week
measure: Abstinence
time frame: 12-weeks (end of treatment)
description: The proportion of participants who achieve total abstinence from combustible cigarettes (defined as no cigarette smoking in the past 7 days)
measure: Number of cigarettes smoked
time frame: 18-weeks (end of trial)
description: The total number of cigarettes smoked in the 7 days prior to the last assessment
measure: CO level
time frame: 12-weeks
description: in ppm
measure: Blood Pressure
time frame: 12-weeks
description: systolic blood pressure and diastolic blood pressure in mm hg
measure: Heart Rate
time frame: 12-weeks
description: beats per minute
measure: Weight
time frame: 12-weeks
description: in pounds
measure: self-report of respiratory symptoms
time frame: 12-weeks
description: The St. George's Respiratory Questionnaire (SGRQ)
measure: nicotine dependence
time frame: 12-weeks
description: Fagerstrom Test for Nicotine Dependence
arm group label: Usual SREC pods Flavor
arm group type: Active Comparator
description: The liquid in the e-cigarette refills contains nicotine and comes in the following flavors: tobacco, menthol, blueberry, and watermelon. The participant will receive SREC pods in their usual flavor.
arm group label: Choice of SREC pods Flavors
arm group type: Active Comparator
description: The liquid in the e-cigarette refills contains nicotine and comes in the following flavors: tobacco, menthol, blueberry, and watermelon. The participant will receive SREC pods in their choice of flavor.
intervention type: Behavioral
intervention name: Brief behavioral counseling
description: Staff will engage in behavioral counseling to identify strategies for reducing combustible cigarette use. All participants in the trial receive this intervention
arm group label: Choice of SREC pods Flavors
arm group label: Usual SREC pods Flavor
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Robin Mermelstein, PhD
role: Principal Investigator
affiliation: University of Illinois at Chicago
last name: Kathleen Diviak, PhD
phone: 312-996-2327
email: kdiviak@uic.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Illinois at Chicago
investigator full name: Robin Mermelstein
investigator title: Distinguished Professor and Director
sharing ipd: Yes
ipd description: Within two years after the final data collection is completed, the investigators will create a completely de-identified data set will that obfuscate any variable that might potentially be used to identify an individual study participant. Data collection instruments, codebooks, and other data documentation will be made available in conjunction with this dataset in a standard format that is readable across a variety of applications and operating system platforms.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: Data will become available no later than two years after the final data collection is completed. There is no time frame identified for stopping the sharing of the data.
ipd access criteria: A data sharing agreement will be required for release of any data. Individuals requesting a copy of study data will need to submit a detailed research plan that includes the purpose of the proposed research, the variables required, the duration of the analysis phase, IRB approval with FWA information, investigator training in human subjects and other approvals specific to the individual datasets. They will also be required to submit a Data Protection Plan or Institutional Privacy Policy, describing the computing environment in which data will be managed and analyzed and how physical access to computing equipment will be controlled. Data will only be released once all IRB approvals and Human Subjects concerns have been addressed.