<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/NCT04465318</url>
  </required_header>
  <id_info>
    <org_study_id>20-00839</org_study_id>
    <nct_id>NCT04465318</nct_id>
  </id_info>
  <brief_title>Electronic Cigarettes as a Harm Reduction Strategy Among Patients With COPD</brief_title>
  <official_title>Electronic Cigarettes as a Harm Reduction Strategy Among Patients With COPD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NYU Langone 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 study team proposes a two-arm pilot study randomizing participants with COPD who smoke&#xD;
      combustible cigarettes (CC) to counseling + NRT (standard of care) or counseling +&#xD;
      e-cigarettes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Globally, chronic obstructive pulmonary disease (COPD) is projected to be the third largest&#xD;
      cause of death by 2030 and in the US over 16 million people have COPD. Smokers are four and a&#xD;
      half times more likely to develop COPD than non-smokers, with the likelihood of COPD&#xD;
      increasing progressively with the duration and intensity of smoking. Among those with COPD,&#xD;
      smoking cessation is the most effective means of slowing the decline of lung function and&#xD;
      overall disease progression. Patients at all stages of COPD benefit from quitting smoking.&#xD;
      Over 90% of COPD deaths occur in current smokers, however 47.1% of people with COPD continue&#xD;
      to smoke. Electronic cigarettes (E-cigarettes) could help people reduce the harm of&#xD;
      combustible cigarettes (CC) through reductions in number of Cigarettes per Day (CPD) or&#xD;
      quitting CC completely by addressing both nicotine and behavioral dependence. Although there&#xD;
      are associated health risks, all available evidence indicates that E-cigarettes are safer&#xD;
      than CC. Unlike CC, e-cigarettes are not associated with coronary heart disease or myocardial&#xD;
      infarction. The purpose of this mixed methods study is to identify barriers and facilitators,&#xD;
      as well as to assess preliminary effectiveness of e-cigarettes as a harm reduction strategy&#xD;
      among people with COPD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 9, 2020</start_date>
  <completion_date type="Actual">March 9, 2023</completion_date>
  <primary_completion_date type="Actual">March 8, 2023</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants who achieve 50% reduction in Cigarettes Per Day (CPD)</measure>
    <time_frame>12 weeks</time_frame>
    <description>Smoking reduction will be measured by a self-report.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Average change in score on the mMRC Dyspnea Scale</measure>
    <time_frame>Baseline, 12 weeks</time_frame>
    <description>The mMRC Dyspnea Scale is a self-rating tool that quantifies disability attributable to breathlessness. The score ranges from 0 to 4. The higher the score, the higher the disability of breathlessness poses on day-to-day activities.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants who reported satisfaction with use of e-cigarettes</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants who reported additional use of tobacco products and/or marijuana</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in score of COPD Assessment Test (CAT)</measure>
    <time_frame>Baseline, 12 weeks</time_frame>
    <description>CAT consists of 8 statements, each scored between 0-5 for a total score range of 0-40. The higher the score, the worse the COPD symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in score of Clinical COPD Questionnaire (CCQ)</measure>
    <time_frame>Baseline, 12 weeks</time_frame>
    <description>CCQ consists of 10 questions, each scored between 0-6 for a total score range of 0-60. The higher the score, the worse the COPD symptoms and more limitations due to the COPD symptoms.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">146</enrollment>
  <condition>COPD</condition>
  <arm_group>
    <arm_group_label>E-cigarettes (EC)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>EC + Counseling</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nicotine Replacement Therapy (NRT)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>NRT + Counseling</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>E-cigarette (EC)</intervention_name>
    <description>NJOY Daily E-cigarettes are self-contained and non-refillable. Each DAILY provides approximately 300 puffs, comparable to a full pack of cigarettes.</description>
    <arm_group_label>E-cigarettes (EC)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Nicotine Replacement Therapy (NRT)</intervention_name>
    <description>Participants in the NRT arm will receive 21 mg nicotine patch (for those with CPD &gt;= 20) or 14 mg nicotine patch (for those with CPD &lt; 20) + 4 mg nicotine gum. CPD stands for Cigarettes Per Day.</description>
    <arm_group_label>Nicotine Replacement Therapy (NRT)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Smoking Harm Reduction Counseling Sessions</intervention_name>
    <description>Counseling will cover health education, social support issues, and motivational enhancement to improve self-efficacy while addressing other aspects know to contribute to smoking among people with COPD (e.g., tips on dealing with depression)</description>
    <arm_group_label>E-cigarettes (EC)</arm_group_label>
    <arm_group_label>Nicotine Replacement Therapy (NRT)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. an ambulatory ICD-10 code for COPD in the last 12 months and a COPD Assessment Tool&#xD;
             (CAT) score on the screening ≥10.&#xD;
&#xD;
          2. ages 21-75 (the legal age for purchasing e-cigarettes is 21)&#xD;
&#xD;
          3. current CC smokers (more than 5 packs in a lifetime; smokes 4 or more days/week)&#xD;
&#xD;
          4. smokes at least 10 cigarettes per day on days they smoke CC&#xD;
&#xD;
          5. motivated to quit smoking (at least a 5 on a 10-point Likert scale)&#xD;
&#xD;
          6. Participants must be able to provide consent, agree to be randomized and followed-up&#xD;
             with, a working telephone number and/or a system with teleconferencing capabilities&#xD;
             (e.g. smartphone or computer), a phone with text messaging capabilities, and be&#xD;
             willing to use an e-cigarette or NRT for 12 weeks. To reduce attrition, participants&#xD;
             will be asked to provide one additional contact as a backup for follow up on&#xD;
             appointments.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. A CAT score &gt;30 representing severe COPD&#xD;
&#xD;
          2. are pregnant (as determined by urine pregnancy test for women under age 52) or&#xD;
             breastfeeding (self-reported). Women of childbearing age must also be willing to use&#xD;
             an approved form of birth control during the course of the study if not practicing&#xD;
             abstinence. Approved birth control methods include: hormonal birth control (e.g. &quot;the&#xD;
             pill&quot;), barrier methods (e.g. condoms, diaphragm), and intrauterine devices (IUDs).&#xD;
&#xD;
          3. diagnosis of any medical condition (unstable angina/heart disease) or psychiatric&#xD;
             condition precluding use of nicotine patch or gum as determined by the MD of this&#xD;
             study, Dr. Scott Sherman (NYS license #171632), or by the subject's primary care&#xD;
             doctor.&#xD;
&#xD;
          4. reporting using NRTs or e-cigarettes within the last 30 days&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Scott E. Sherman, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>NYU Langone Health</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Elizabeth Stevens, PhD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>NYU Langone Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NYU Langone Health</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>June 14, 2023</last_update_submitted>
  <last_update_submitted_qc>June 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>E-cigarettes</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nicotine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.</ipd_time_frame>
    <ipd_access_criteria>The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to scott.sherman@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.</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/NCT04465318
org study id: 20-00839
nct id: NCT04465318
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study team proposes a two-arm pilot study randomizing participants with COPD who smoke
      combustible cigarettes (CC) to counseling + NRT (standard of care) or counseling +
      e-cigarettes.
Globally, chronic obstructive pulmonary disease (COPD) is projected to be the third largest
      cause of death by 2030 and in the US over 16 million people have COPD. Smokers are four and a
      half times more likely to develop COPD than non-smokers, with the likelihood of COPD
      increasing progressively with the duration and intensity of smoking. Among those with COPD,
      smoking cessation is the most effective means of slowing the decline of lung function and
      overall disease progression. Patients at all stages of COPD benefit from quitting smoking.
      Over 90% of COPD deaths occur in current smokers, however 47.1% of people with COPD continue
      to smoke. Electronic cigarettes (E-cigarettes) could help people reduce the harm of
      combustible cigarettes (CC) through reductions in number of Cigarettes per Day (CPD) or
      quitting CC completely by addressing both nicotine and behavioral dependence. Although there
      are associated health risks, all available evidence indicates that E-cigarettes are safer
      than CC. Unlike CC, e-cigarettes are not associated with coronary heart disease or myocardial
      infarction. The purpose of this mixed methods study is to identify barriers and facilitators,
      as well as to assess preliminary effectiveness of e-cigarettes as a harm reduction strategy
      among people with COPD.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Number of participants who achieve 50% reduction in Cigarettes Per Day (CPD)
time frame: 12 weeks
description: Smoking reduction will be measured by a self-report.
measure: Average change in score on the mMRC Dyspnea Scale
time frame: Baseline, 12 weeks
description: The mMRC Dyspnea Scale is a self-rating tool that quantifies disability attributable to breathlessness. The score ranges from 0 to 4. The higher the score, the higher the disability of breathlessness poses on day-to-day activities.
measure: Number of participants who reported satisfaction with use of e-cigarettes
time frame: 12 weeks
measure: Number of participants who reported additional use of tobacco products and/or marijuana
time frame: 12 weeks
measure: Change in score of COPD Assessment Test (CAT)
time frame: Baseline, 12 weeks
description: CAT consists of 8 statements, each scored between 0-5 for a total score range of 0-40. The higher the score, the worse the COPD symptoms.
measure: Change in score of Clinical COPD Questionnaire (CCQ)
time frame: Baseline, 12 weeks
description: CCQ consists of 10 questions, each scored between 0-6 for a total score range of 0-60. The higher the score, the worse the COPD symptoms and more limitations due to the COPD symptoms.
arm group label: E-cigarettes (EC)
arm group type: Experimental
description: EC + Counseling
arm group label: Nicotine Replacement Therapy (NRT)
arm group type: Active Comparator
description: NRT + Counseling
intervention type: Other
intervention name: E-cigarette (EC)
description: NJOY Daily E-cigarettes are self-contained and non-refillable. Each DAILY provides approximately 300 puffs, comparable to a full pack of cigarettes.
arm group label: E-cigarettes (EC)
intervention type: Other
intervention name: Nicotine Replacement Therapy (NRT)
description: Participants in the NRT arm will receive 21 mg nicotine patch (for those with CPD >= 20) or 14 mg nicotine patch (for those with CPD < 20) + 4 mg nicotine gum. CPD stands for Cigarettes Per Day.
arm group label: Nicotine Replacement Therapy (NRT)
intervention type: Behavioral
intervention name: Smoking Harm Reduction Counseling Sessions
description: Counseling will cover health education, social support issues, and motivational enhancement to improve self-efficacy while addressing other aspects know to contribute to smoking among people with COPD (e.g., tips on dealing with depression)
arm group label: E-cigarettes (EC)
arm group label: Nicotine Replacement Therapy (NRT)
criteria: 
gender: All
minimum age: 21 Years
maximum age: 75 Years
healthy volunteers: No
last name: Scott E. Sherman, MD, MPH
role: Principal Investigator
affiliation: NYU Langone Health
last name: Elizabeth Stevens, PhD, MPH
role: Principal Investigator
affiliation: NYU Langone Health
facility: 
country: United States
responsible party type: Sponsor
mesh term: Nicotine
sharing ipd: Yes
ipd description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
ipd access criteria: The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to scott.sherman@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.