<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/NCT03000387</url>
  </required_header>
  <id_info>
    <org_study_id>039/2015</org_study_id>
    <nct_id>NCT03000387</nct_id>
  </id_info>
  <brief_title>Personalized Dosing of Nicotine Replacement (NRT to Effect)</brief_title>
  <official_title>Personalized Dosing of Nicotine Replacement for Smoking Cessation: An Effectiveness Randomized Placebo-controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre for Addiction and Mental Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Canadian Cancer Society (CCS)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ottawa Heart Institute Research Corporation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre for Addiction and Mental 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>
      Medications for smoking cessation are currently only effective in helping a minority of&#xD;
      smokers quit. Drug development is slow and expensive, so there is much interest in optimizing&#xD;
      the effectiveness of existing treatments and medications. Current standard doses of nicotine&#xD;
      replacement therapy (NRT) are not effective for many smokers and in many cases provide less&#xD;
      nicotine compared to when a smoker is smoking their usual number of cigarettes. The proposed&#xD;
      study will test if a personalized dose of nicotine patch (up to 84mg) will improve quitting&#xD;
      success in those who do not respond to a standard dose of NRT (21mg).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A total of 500 smokers will be enrolled from two smoking cessation clinics to participate in&#xD;
      this study. After 2 weeks of usual treatment with 21mg patch, participants who fail to quit&#xD;
      smoking will be randomized to receive either escalating doses of active nicotine patches, or&#xD;
      placebo patches, for 10 weeks. Those who stop smoking during the first 2 weeks of usual&#xD;
      treatment will continue with 21mg patch treatment for 10 weeks as an additional comparison&#xD;
      group. In addition to the medication, participants in all groups will receive brief&#xD;
      behavioral counselling. Subjects will return to the clinic at weeks 26 and 52 to assess&#xD;
      whether or not they are still abstinent from smoking and self-reports of non-smoking will be&#xD;
      confirmed using a urine test for nicotine by-product (cotinine) levels. Exhaled carbon&#xD;
      monoxide (CO) will be recorded as an additional measure. Study follow-up visits can be&#xD;
      conducted virtually if needed.&#xD;
&#xD;
      The goal of the proposed study is to optimize the current gold standard smoking cessation&#xD;
      treatment (nicotine patch plus brief counseling) in order to further increase quit rates.&#xD;
      Evidence supporting the effectiveness of personalized doses of NRT could change current&#xD;
      practice in a wide variety of healthcare settings. Given the strong link between smoking and&#xD;
      cancer, and evidence that quitting smoking at any age diminishes this risk, even small&#xD;
      increases in absolute quit rates can have a substantial population-level impact on reducing&#xD;
      the incidence of smoking-related cancers, reducing mortality rates and associated healthcare&#xD;
      costs.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 23, 2018</start_date>
  <completion_date type="Anticipated">December 12, 2023</completion_date>
  <primary_completion_date type="Actual">February 27, 2023</primary_completion_date>
  <phase>Phase 4</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>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Short term continuous abstinence</measure>
    <time_frame>weeks 9 to 12</time_frame>
    <description>YES, If self-reported 4 weeks of abstinence without a single puff of a cigarette or any other tobacco product. Else, NO.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Long term continuous abstinence</measure>
    <time_frame>weeks 9-26</time_frame>
    <description>YES, if self-reported abstinence without a single puff of cigarette and urine cotinine less than 200ng/ml. Else, NO.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Long term continuous abstinence</measure>
    <time_frame>weeks 9-52</time_frame>
    <description>YES, if, self-reported abstinence without a single puff of cigarette and urine cotinine less than 200ng/ml. Else, NO.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">211</enrollment>
  <condition>Tobacco Use Disorder</condition>
  <condition>Nicotine Dependence</condition>
  <arm_group>
    <arm_group_label>Experimental Condition</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants unable to quit smoking after 2 weeks of treatment with 21mg nicotine patch will get 21mg nicotine patches plus additional active nicotine patches until achieving 7 consecutive days of abstinence over the next 5 weeks; maximum daily patch dose, 84mg/day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Condition</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participant unable to quit smoking after 2 weeks of treatment with 21mg nicotine patch will get 21mg nicotine patches plus placebo patches until 7 consecutive days of abstinence over the next 5 weeks; Maximum daily patch dose, 21mg active nicotine patch plus 3 placebo 21mg patches.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Quit condition</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants able to quit for 7 consecutive days during the first 2 weeks of treatment with 21mg nicotine patch will continue open label 21mg active nicotine patches for the remaining 10 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nicotine Patch</intervention_name>
    <description>Active nicotine patch of 21 mg, 14 mg and 7 mg</description>
    <arm_group_label>Experimental Condition</arm_group_label>
    <arm_group_label>Placebo Condition</arm_group_label>
    <arm_group_label>Quit condition</arm_group_label>
    <other_name>Nicoderm</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebos</intervention_name>
    <description>Matching placebo patches of 21 mg, 14 mg and 7 mg</description>
    <arm_group_label>Placebo Condition</arm_group_label>
    <other_name>Placebo patch</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Daily tobacco smoker of ≥10 cigarettes per day&#xD;
&#xD;
          2. Aged 18 to 75 years old&#xD;
&#xD;
          3. Interested in using tNRT as the only smoking cessation aid&#xD;
&#xD;
          4. Intending to quit smoking within the next 30 days&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. At least weekly use of tobacco products other than cigarettes and not willing to stop&#xD;
             for the duration of the study&#xD;
&#xD;
          2. Breast feeding, pregnancy or not using a reliable form of birth control&#xD;
&#xD;
          3. Any generalized skin disorders precluding the use of the patch&#xD;
&#xD;
          4. Any life threatening arrhythmias or severe/worsening angina pectoris or within two&#xD;
             weeks of experiencing a myocardial infarction or cerebral vascular accident&#xD;
&#xD;
          5. Currently using or has used NRT or other smoking cessation pharmacotherapy within the&#xD;
             past two weeks&#xD;
&#xD;
          6. Any known hypersensitivity or allergies to any of the components comprising the&#xD;
             nicotine patch&#xD;
&#xD;
          7. Current active substance dependence (excluding caffeine) which would compromise study&#xD;
             compliance&#xD;
&#xD;
          8. Current unstable psychiatric condition which would compromise study compliance&#xD;
&#xD;
          9. Diagnosis of terminal illness&#xD;
&#xD;
         10. Current regular use of e-cigarettes or other vaping devices containing nicotine and&#xD;
             not willing to stop for the duration of the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Laurie Zawertailo, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre for Addiction and Mental Health</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Peter Selby, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre for Addiction and Mental Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Ottawa Heart Institute</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1Y 4W7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre for Addiction and Mental Health</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M6J 1H4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>November 17, 2016</study_first_submitted>
  <study_first_submitted_qc>December 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 22, 2016</study_first_posted>
  <last_update_submitted>September 7, 2023</last_update_submitted>
  <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centre for Addiction and Mental Health</investigator_affiliation>
    <investigator_full_name>Laurie Zawertailo</investigator_full_name>
    <investigator_title>Senior Scientist</investigator_title>
  </responsible_party>
  <keyword>Nicotine Replacement Therapy</keyword>
  <keyword>Smoking Cessation</keyword>
  <keyword>Randomized Clinical Trial</keyword>
  <keyword>Nicotine Patch</keyword>
  <keyword>Abstinence</keyword>
  <keyword>Placebo</keyword>
  <keyword>Double blind</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>
  <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/NCT03000387
org study id: 039/2015
nct id: NCT03000387
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Medications for smoking cessation are currently only effective in helping a minority of
      smokers quit. Drug development is slow and expensive, so there is much interest in optimizing
      the effectiveness of existing treatments and medications. Current standard doses of nicotine
      replacement therapy (NRT) are not effective for many smokers and in many cases provide less
      nicotine compared to when a smoker is smoking their usual number of cigarettes. The proposed
      study will test if a personalized dose of nicotine patch (up to 84mg) will improve quitting
      success in those who do not respond to a standard dose of NRT (21mg).
A total of 500 smokers will be enrolled from two smoking cessation clinics to participate in
      this study. After 2 weeks of usual treatment with 21mg patch, participants who fail to quit
      smoking will be randomized to receive either escalating doses of active nicotine patches, or
      placebo patches, for 10 weeks. Those who stop smoking during the first 2 weeks of usual
      treatment will continue with 21mg patch treatment for 10 weeks as an additional comparison
      group. In addition to the medication, participants in all groups will receive brief
      behavioral counselling. Subjects will return to the clinic at weeks 26 and 52 to assess
      whether or not they are still abstinent from smoking and self-reports of non-smoking will be
      confirmed using a urine test for nicotine by-product (cotinine) levels. Exhaled carbon
      monoxide (CO) will be recorded as an additional measure. Study follow-up visits can be
      conducted virtually if needed.

      The goal of the proposed study is to optimize the current gold standard smoking cessation
      treatment (nicotine patch plus brief counseling) in order to further increase quit rates.
      Evidence supporting the effectiveness of personalized doses of NRT could change current
      practice in a wide variety of healthcare settings. Given the strong link between smoking and
      cancer, and evidence that quitting smoking at any age diminishes this risk, even small
      increases in absolute quit rates can have a substantial population-level impact on reducing
      the incidence of smoking-related cancers, reducing mortality rates and associated healthcare
      costs.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Short term continuous abstinence
time frame: weeks 9 to 12
description: YES, If self-reported 4 weeks of abstinence without a single puff of a cigarette or any other tobacco product. Else, NO.
measure: Long term continuous abstinence
time frame: weeks 9-26
description: YES, if self-reported abstinence without a single puff of cigarette and urine cotinine less than 200ng/ml. Else, NO.
measure: Long term continuous abstinence
time frame: weeks 9-52
description: YES, if, self-reported abstinence without a single puff of cigarette and urine cotinine less than 200ng/ml. Else, NO.
arm group label: Experimental Condition
arm group type: Experimental
description: Participants unable to quit smoking after 2 weeks of treatment with 21mg nicotine patch will get 21mg nicotine patches plus additional active nicotine patches until achieving 7 consecutive days of abstinence over the next 5 weeks; maximum daily patch dose, 84mg/day
arm group label: Placebo Condition
arm group type: Placebo Comparator
description: Participant unable to quit smoking after 2 weeks of treatment with 21mg nicotine patch will get 21mg nicotine patches plus placebo patches until 7 consecutive days of abstinence over the next 5 weeks; Maximum daily patch dose, 21mg active nicotine patch plus 3 placebo 21mg patches.
arm group label: Quit condition
arm group type: Active Comparator
description: Participants able to quit for 7 consecutive days during the first 2 weeks of treatment with 21mg nicotine patch will continue open label 21mg active nicotine patches for the remaining 10 weeks.
intervention type: Drug
intervention name: Nicotine Patch
description: Active nicotine patch of 21 mg, 14 mg and 7 mg
arm group label: Experimental Condition
arm group label: Placebo Condition
arm group label: Quit condition
other name: Nicoderm
intervention type: Drug
intervention name: Placebos
description: Matching placebo patches of 21 mg, 14 mg and 7 mg
arm group label: Placebo Condition
other name: Placebo patch
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Laurie Zawertailo, PhD
role: Principal Investigator
affiliation: Centre for Addiction and Mental Health
last name: Peter Selby, MBBS
role: Principal Investigator
affiliation: Centre for Addiction and Mental Health
facility: 
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Centre for Addiction and Mental Health
investigator full name: Laurie Zawertailo
investigator title: Senior Scientist
mesh term: Tobacco Use Disorder
mesh term: Nicotine
sharing ipd: No