<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/NCT03249428</url>
  </required_header>
  <id_info>
    <org_study_id>E-Cigarette Inner City RCT 001</org_study_id>
    <nct_id>NCT03249428</nct_id>
  </id_info>
  <brief_title>E-Cigarette Inner City RCT</brief_title>
  <official_title>A Community-Based Participatory Action Pragmatic Randomized Controlled Trial Using Electronic-Cigarette for Tobacco Dependence in the Inner City Population With a Holistic Approach</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ottawa Hospital Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ottawa Hospital Research Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Tobacco is the most preventable cause of disease and death in Canada. Although the tobacco&#xD;
      use rate has substantially gone down in the general population, significant differences exist&#xD;
      between sub-populations in Canada, for example Ottawa's highly vulnerable homeless or at-risk&#xD;
      for homelessness population has an almost 100% tobacco smoking rate relative to 9-18% in the&#xD;
      rest of the Canadian general population. This stark inequity in tobacco use translates into&#xD;
      devastating healthcare outcomes such as a disproportionate amount of cancer, stroke, heart&#xD;
      disease and death. Canadians who are homeless or at-risk for homelessness die 25 years&#xD;
      earlier than housed Canadians, mostly due to tobacco. In order to tackle this tobacco use&#xD;
      related inequity - a novel approach is urgently needed. Despite commonly held dogma that&#xD;
      People Who Use Drugs (PWUD) don't want to quit smoking, many studies have demonstrated that&#xD;
      in fact they are very interested in quitting. Moreover, the investigators pragmatic peer-led&#xD;
      community-based action approach used in their PROMPT project has demonstrated that tobacco&#xD;
      dependence strategies can be implemented with great success in this population. The majority&#xD;
      of PROMPT participants reduced or quit tobacco use, in addition to reducing or quitting all&#xD;
      other drug use. Importantly, the investigators have demonstrated that it is possible to gain&#xD;
      the trust and engagement of marginalized populations and that researchers can create a&#xD;
      community space that is low-threshold, safe and non-judgmental. The investigators aim to&#xD;
      compare two tobacco dependence management strategies in the homeless (or at-risk for&#xD;
      homelessness) multi-drug use population in Ottawa and Toronto. They will use the same&#xD;
      peer-led approach in PROMPT with community peer researchers with lived experience; with the&#xD;
      hope that the cost-effective community based framework derived from this trial will serve as&#xD;
      a template for interventions and treatments in community settings for chronic diseases such&#xD;
      as obesity and diabetes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aim: A 3-yr multi-centre, pragmatic Randomized Controlled Trial (RCT) to compare&#xD;
      effectiveness of nicotine e-cigarettes (e-cigs) (with counseling) with peer-led PROMPT&#xD;
      strategy (nicotine replacement therapy (NRT) and counseling) for tobacco dependence in the&#xD;
      inner city population.&#xD;
&#xD;
      Background: Homelessness/at-risk for homelessness populations in Canada carry&#xD;
      disproportionate burden of many diseases, mostly due to tobacco. With smoking rates at ~100%&#xD;
      in some subpopulations as compared to 9-18% in the general population, tobacco inequity is&#xD;
      translated into unequal morbidity and mortality (COPD, cancers, heart diseases). Tobacco use&#xD;
      costs the Ontario economy ~$1.6 billion/yr in healthcare costs. Smoking attributable&#xD;
      hospitalization costs ~$38.2 million/yr in Ottawa alone from 2008-10. The inner city&#xD;
      population in Canada dies ~25 yrs earlier than housed Canadians, largely due to tobacco. With&#xD;
      negligible quit rates using conventional strategies, novel approaches to address tobacco&#xD;
      inequity are urgently needed.&#xD;
&#xD;
      Study Population: 200 Toronto and Ottawa inner city homeless/ at-risk for homelessness&#xD;
      participants using poly-substances.&#xD;
&#xD;
      Primary Patient-Oriented Outcome: To assess impact of two tobacco dependence strategies on&#xD;
      quality of life (QOL) measured by questionnaire (EQ-5D-5L scores) at 26 wks; Secondary: i) To&#xD;
      assess effectiveness of these two strategies with biochemically validated 7-day point&#xD;
      prevalence smoking abstinence at 12, 26 and 52 wks; ii) To assess effectiveness of these two&#xD;
      strategies on cigarette use reduction and cessation at 12, 26 and 52 wks; iii) To assess&#xD;
      self-reported reduction and cessation of other illicit drug use; and; iv) To describe the&#xD;
      safety/tolerability of nicotine e-cigs serious adverse events (SAEs), adverse events (AEs),&#xD;
      drop-outs due to side effects, and therapy adherence over 52 wks; and, v) To compare the lung&#xD;
      function (spirometry/oscillometry), 6-min walk and self-efficacy at baseline, 26 and 52 wks;&#xD;
      Tertiary: i) To assess the cost-effectiveness of the pragmatic tobacco dependence strategies.&#xD;
&#xD;
      Study Design: A multi-centre pragmatic RCT trial comparing e-cigs (with nicotine) with&#xD;
      counseling or NRT with counseling for a 26 wks treatment period and 52 wks follow up. Similar&#xD;
      to the real world all participants will be given an opportunity to choose either strategy at&#xD;
      26 wks. The primary analysis will be change in QOL measured with EQ-5D-5L at 26 wks between&#xD;
      participants.&#xD;
&#xD;
      Setting: 1) The Bridge Engagement Centre, Ottawa, adjacent to the largest homeless shelter&#xD;
      downtown; and 2) Nicotine Dependence Clinic, Center for Addiction and Mental Health, catering&#xD;
      Toronto's inner city population downtown.&#xD;
&#xD;
      Expertise: Both PIs are well versed in community-based research and Dr. Pakhale led the&#xD;
      PROMPT project, a community based smoking cessation project engaging the same target&#xD;
      population. Together the team is very experienced in tobacco dependence and the target&#xD;
      population. The investigators collective expertise with links to the target community will&#xD;
      support the implementation of the trial.&#xD;
&#xD;
      Outcomes: Pragmatic community-based participatory and peer-led research holds a tremendous&#xD;
      potential in investigating solutions 'for the people, by and with the people'. Outcomes of&#xD;
      this trial will aid policy makers in implementing effective programs to treat tobacco&#xD;
      dependence in marginalized population. The cost-effective community based framework of this&#xD;
      trial can be used as a template for intervention in other chronic diseases (e.g. obesity or&#xD;
      diabetes).&#xD;
&#xD;
      Timeline: The trial will require 3 yrs to complete.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 2019</start_date>
  <completion_date type="Anticipated">September 2021</completion_date>
  <primary_completion_date type="Anticipated">September 2021</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>3-yr multi-centre pragmatic Randomized Controlled Trial (RCT) to compare effectiveness of nicotine e-cigarettes (e-cigs) (with counseling) with peer-led PROMPT strategy (nicotine replacement therapy (NRT) and counseling) for tobacco dependence in the inner city population.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>Research staff analyzing the data and members of the data and safety monitoring committee will be blinded to the treatment. allotment.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Quality of Life</measure>
    <time_frame>26 weeks</time_frame>
    <description>To assess impact of two tobacco dependence strategies on quality of life (QOL) measured by questionnaire (EQ-5D-5L scores) at 26 weeks</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Smoking Prevalence</measure>
    <time_frame>52 weeks</time_frame>
    <description>To assess effectiveness of these two strategies with biochemically validated 7-day point prevalence smoking abstinence at 12, 26 and 52 weeks</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Tobacco Dependence</condition>
  <condition>COPD Asthma</condition>
  <condition>Mental Illness</condition>
  <condition>Substance Use</condition>
  <arm_group>
    <arm_group_label>Nicotine Replacement Therapy &amp; One-on-One Counseling</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard NRT such as the nicotine patch, gum, inhaler, and/or lozenge as per participant liking and clinical indication deemed necessary by the expert smoking cessation nurse. Counseling will include a number of approaches such as reviewing smoking history, development and revision of a reduced or quit plan, encouragement of self-monitoring, review of triggers and challenges, and coping skills.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Electronic Nicotine Delivery Systems &amp; One-on-One Counseling</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Electronic Nicotine Delivery Systems with nicotine. Counseling will include a number of approaches such as reviewing smoking history, development and revision of a reduced or quit plan, encouragement of self-monitoring, review of triggers and challenges, and coping skills.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Improved Quality of Life of low-income Canadians that smoke tobacco and other substances</intervention_name>
    <description>Assess effectiveness, safety and tolerability of electronic-cigarettes (e-cigs) with nicotine or Nicotine Replacement Therapy (NRT) with individual counseling for tobacco cessation.</description>
    <arm_group_label>Electronic Nicotine Delivery Systems &amp; One-on-One Counseling</arm_group_label>
    <arm_group_label>Nicotine Replacement Therapy &amp; One-on-One Counseling</arm_group_label>
    <other_name>NJOY Recharge BOLD</other_name>
    <other_name>Nicotine Replacement Therapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  16 years or older&#xD;
&#xD;
          -  Living in Ottawa or Toronto over the past 3 months&#xD;
&#xD;
          -  Using poly-substances within the past year, excluding marijuana or alcohol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Consent declined (refusal from participant or decision maker)&#xD;
&#xD;
          -  Any person who is in or planning on accessing addictions treatment (in-patient drug&#xD;
             rehabilitation) in Ottawa or Toronto and hence will be unavailable for follow up&#xD;
&#xD;
          -  Currently or recently (in the past 30 days) enrolled in any other smoking cessation&#xD;
             program or have used/is using any e-cigs (nicotine or non-nicotine) in the past 60&#xD;
             days&#xD;
&#xD;
          -  Terminal illness with a life expectancy of less than 3 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Smita Pakhale, MD</last_name>
    <phone>613-737-8899</phone>
    <phone_ext>79979</phone_ext>
    <email>spakhale@ohri.ca</email>
  </overall_contact>
  <location>
    <facility>
      <name>The Bridge Engagement Centre</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1G 5T2</zip>
        <country>Canada</country>
      </address>
    </facility>
    <contact>
      <last_name>Smita Pakhale, MD, MSc</last_name>
      <phone>613-737-8899</phone>
      <phone_ext>79428</phone_ext>
    </contact>
    <contact_backup>
      <last_name>Sadia Jama, MSc</last_name>
      <phone>613-518-7172</phone>
      <email>sajama@ohri.ca</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>August 10, 2017</study_first_submitted>
  <study_first_submitted_qc>August 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <last_update_submitted>March 19, 2019</last_update_submitted>
  <last_update_submitted_qc>March 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 21, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Substance-Related Disorders</mesh_term>
    <mesh_term>Tobacco Use Disorder</mesh_term>
    <mesh_term>Mental Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nicotine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03249428
org study id: E-Cigarette Inner City RCT 001
nct id: NCT03249428
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
Tobacco is the most preventable cause of disease and death in Canada. Although the tobacco
      use rate has substantially gone down in the general population, significant differences exist
      between sub-populations in Canada, for example Ottawa's highly vulnerable homeless or at-risk
      for homelessness population has an almost 100% tobacco smoking rate relative to 9-18% in the
      rest of the Canadian general population. This stark inequity in tobacco use translates into
      devastating healthcare outcomes such as a disproportionate amount of cancer, stroke, heart
      disease and death. Canadians who are homeless or at-risk for homelessness die 25 years
      earlier than housed Canadians, mostly due to tobacco. In order to tackle this tobacco use
      related inequity - a novel approach is urgently needed. Despite commonly held dogma that
      People Who Use Drugs (PWUD) don't want to quit smoking, many studies have demonstrated that
      in fact they are very interested in quitting. Moreover, the investigators pragmatic peer-led
      community-based action approach used in their PROMPT project has demonstrated that tobacco
      dependence strategies can be implemented with great success in this population. The majority
      of PROMPT participants reduced or quit tobacco use, in addition to reducing or quitting all
      other drug use. Importantly, the investigators have demonstrated that it is possible to gain
      the trust and engagement of marginalized populations and that researchers can create a
      community space that is low-threshold, safe and non-judgmental. The investigators aim to
      compare two tobacco dependence management strategies in the homeless (or at-risk for
      homelessness) multi-drug use population in Ottawa and Toronto. They will use the same
      peer-led approach in PROMPT with community peer researchers with lived experience; with the
      hope that the cost-effective community based framework derived from this trial will serve as
      a template for interventions and treatments in community settings for chronic diseases such
      as obesity and diabetes.
Aim: A 3-yr multi-centre, pragmatic Randomized Controlled Trial (RCT) to compare
      effectiveness of nicotine e-cigarettes (e-cigs) (with counseling) with peer-led PROMPT
      strategy (nicotine replacement therapy (NRT) and counseling) for tobacco dependence in the
      inner city population.

      Background: Homelessness/at-risk for homelessness populations in Canada carry
      disproportionate burden of many diseases, mostly due to tobacco. With smoking rates at ~100%
      in some subpopulations as compared to 9-18% in the general population, tobacco inequity is
      translated into unequal morbidity and mortality (COPD, cancers, heart diseases). Tobacco use
      costs the Ontario economy ~$1.6 billion/yr in healthcare costs. Smoking attributable
      hospitalization costs ~$38.2 million/yr in Ottawa alone from 2008-10. The inner city
      population in Canada dies ~25 yrs earlier than housed Canadians, largely due to tobacco. With
      negligible quit rates using conventional strategies, novel approaches to address tobacco
      inequity are urgently needed.

      Study Population: 200 Toronto and Ottawa inner city homeless/ at-risk for homelessness
      participants using poly-substances.

      Primary Patient-Oriented Outcome: To assess impact of two tobacco dependence strategies on
      quality of life (QOL) measured by questionnaire (EQ-5D-5L scores) at 26 wks; Secondary: i) To
      assess effectiveness of these two strategies with biochemically validated 7-day point
      prevalence smoking abstinence at 12, 26 and 52 wks; ii) To assess effectiveness of these two
      strategies on cigarette use reduction and cessation at 12, 26 and 52 wks; iii) To assess
      self-reported reduction and cessation of other illicit drug use; and; iv) To describe the
      safety/tolerability of nicotine e-cigs serious adverse events (SAEs), adverse events (AEs),
      drop-outs due to side effects, and therapy adherence over 52 wks; and, v) To compare the lung
      function (spirometry/oscillometry), 6-min walk and self-efficacy at baseline, 26 and 52 wks;
      Tertiary: i) To assess the cost-effectiveness of the pragmatic tobacco dependence strategies.

      Study Design: A multi-centre pragmatic RCT trial comparing e-cigs (with nicotine) with
      counseling or NRT with counseling for a 26 wks treatment period and 52 wks follow up. Similar
      to the real world all participants will be given an opportunity to choose either strategy at
      26 wks. The primary analysis will be change in QOL measured with EQ-5D-5L at 26 wks between
      participants.

      Setting: 1) The Bridge Engagement Centre, Ottawa, adjacent to the largest homeless shelter
      downtown; and 2) Nicotine Dependence Clinic, Center for Addiction and Mental Health, catering
      Toronto's inner city population downtown.

      Expertise: Both PIs are well versed in community-based research and Dr. Pakhale led the
      PROMPT project, a community based smoking cessation project engaging the same target
      population. Together the team is very experienced in tobacco dependence and the target
      population. The investigators collective expertise with links to the target community will
      support the implementation of the trial.

      Outcomes: Pragmatic community-based participatory and peer-led research holds a tremendous
      potential in investigating solutions 'for the people, by and with the people'. Outcomes of
      this trial will aid policy makers in implementing effective programs to treat tobacco
      dependence in marginalized population. The cost-effective community based framework of this
      trial can be used as a template for intervention in other chronic diseases (e.g. obesity or
      diabetes).

      Timeline: The trial will require 3 yrs to complete.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: 3-yr multi-centre pragmatic Randomized Controlled Trial (RCT) to compare effectiveness of nicotine e-cigarettes (e-cigs) (with counseling) with peer-led PROMPT strategy (nicotine replacement therapy (NRT) and counseling) for tobacco dependence in the inner city population.
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
masking description: Research staff analyzing the data and members of the data and safety monitoring committee will be blinded to the treatment. allotment.
measure: Overall Quality of Life
time frame: 26 weeks
description: To assess impact of two tobacco dependence strategies on quality of life (QOL) measured by questionnaire (EQ-5D-5L scores) at 26 weeks
measure: Smoking Prevalence
time frame: 52 weeks
description: To assess effectiveness of these two strategies with biochemically validated 7-day point prevalence smoking abstinence at 12, 26 and 52 weeks
arm group label: Nicotine Replacement Therapy & One-on-One Counseling
arm group type: Active Comparator
description: Standard NRT such as the nicotine patch, gum, inhaler, and/or lozenge as per participant liking and clinical indication deemed necessary by the expert smoking cessation nurse. Counseling will include a number of approaches such as reviewing smoking history, development and revision of a reduced or quit plan, encouragement of self-monitoring, review of triggers and challenges, and coping skills.
arm group label: Electronic Nicotine Delivery Systems & One-on-One Counseling
arm group type: Active Comparator
description: Electronic Nicotine Delivery Systems with nicotine. Counseling will include a number of approaches such as reviewing smoking history, development and revision of a reduced or quit plan, encouragement of self-monitoring, review of triggers and challenges, and coping skills.
intervention type: Device
intervention name: Improved Quality of Life of low-income Canadians that smoke tobacco and other substances
description: Assess effectiveness, safety and tolerability of electronic-cigarettes (e-cigs) with nicotine or Nicotine Replacement Therapy (NRT) with individual counseling for tobacco cessation.
arm group label: Electronic Nicotine Delivery Systems & One-on-One Counseling
arm group label: Nicotine Replacement Therapy & One-on-One Counseling
other name: NJOY Recharge BOLD
other name: Nicotine Replacement Therapy
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Smita Pakhale, MD
phone: 613-737-8899
phone ext: 79979
email: spakhale@ohri.ca
facility: 
contact: 
contact backup: 
country: Canada
responsible party type: Sponsor
mesh term: Substance-Related Disorders
mesh term: Tobacco Use Disorder
mesh term: Mental Disorders
mesh term: Nicotine
sharing ipd: No