<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/NCT03001440</url>
  </required_header>
  <id_info>
    <org_study_id>205913</org_study_id>
    <nct_id>NCT03001440</nct_id>
  </id_info>
  <brief_title>A 7-year Assessment on Subject Understanding of ZYBAN/ WELLBUTRIN Associated Risks</brief_title>
  <official_title>Subject Understanding of the Risks Associated With ZYBAN®, WELLBUTRIN®, WELLBUTRIN SR®, and WELLBUTRIN XL®</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>United Biosource Corporation (UBC)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Branded bupropion hydrochloride products including ZYBAN and WELLBUTRIN range are approved&#xD;
      for the treatment of smoking cessation and depressive disorders respectively. The Risk&#xD;
      Evaluation and Mitigation Strategy (REMS) for ZYBAN was initially approved in 2010 and&#xD;
      consists of a Medication Guide and a timetable for REMS assessments submission at 18 months,&#xD;
      3 years and 7 years from the date of initial approval of REMS. The present study is a 7-year&#xD;
      REMS assessment to evaluate subjects' understanding of the potential serious risk of&#xD;
      neuropsychiatric adverse events associated with the use of ZYBAN, WELLBUTRIN, WELLBUTRIN SR,&#xD;
      and WELLBUTRIN XL. The assessment will be a 20-minutes Knowledge, Attitudes and Behavior&#xD;
      (KAB) survey and will be conducted among approximately 125 subjects currently using or who&#xD;
      have filled a prescription for a branded bupropion product for smoking cessation within the 6&#xD;
      months prior to survey administration. ZYBAN, WELLBUTRIN, WELLBUTRIN SR, and WELLBUTRIN XL&#xD;
      are registered trade marks of the GSK group of companies.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 7, 2016</start_date>
  <completion_date type="Actual">December 28, 2016</completion_date>
  <primary_completion_date type="Actual">December 28, 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number (No.) of subjects correctly responding to individual survey questions</measure>
    <time_frame>7 years</time_frame>
    <description>The proportion of correct answers to survey questions concerning the risks associated with branded bupropion hydrochloride products will be summarized by use of formulation of ZYBAN or WELLBUTRIN. Smoking behavior, demographic information, information related to the receipt and reading of the Medication Guides and how the branded bupropion hydrochloride product is normally received will also be reported. Point estimates for the proportion with correct responses will be calculated for each question about the risks of branded bupropion products. In the case of multiple choice questions, the number and proportion of subjects reporting each response will also be provided.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1</enrollment>
  <condition>Depressive Disorder, Major</condition>
  <arm_group>
    <arm_group_label>ZYBAN/WELLBUTRIN users</arm_group_label>
    <description>Subjects who currently use or who have filled a prescription for ZYBAN, WELLBUTRIN, WELLBUTRIN SR, or WELLBUTRIN XL for smoking cessation within the previous 6 months will be included in the study. Subjects will be required to complete the KAB survey either online or through a telephone interview.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>KAB survey</intervention_name>
    <description>The KAB survey will be conducted among study population to evaluate their understanding of the potential serious risk with the use of ZYBAN. The 20 minutes survey can be completed either online or through a telephone interview.</description>
    <arm_group_label>ZYBAN/WELLBUTRIN users</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects of age 18 years or older who are currently using or who have filled a prescription&#xD;
        for branded bupropion hydrochloride products including ZYBAN, WELLBUTRIN, WELLBUTRIN SR,&#xD;
        WELLBUTRIN XL within the 6 months prior to survey administration for smoking cessation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects who currently use or who have filled a prescription for ZYBAN, WELLBUTRIN,&#xD;
             WELLBUTRIN SR, or WELLBUTRIN XL for smoking cessation within the previous 6 months.&#xD;
             (Note: Branded bupropion hydrochloride product use will be confirmed through a series&#xD;
             of questions within the screener concerning manufacturer information detailed on the&#xD;
             product label [label on medication container] and following a review of photographs of&#xD;
             generic bupropion, ZYBAN, WELLBUTRIN, WELLBUTRIN SR or WELLBUTRIN XL tablet types&#xD;
             online or via a paper copy sent with the invitation letter for those who choose to&#xD;
             participate via phone)&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  Fluent English speaker (for telephone)&#xD;
&#xD;
          -  Consent to take the online survey or have the survey administered via a telephone&#xD;
             interview&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects taking generic bupropion&#xD;
&#xD;
          -  Subjects who currently use or who have filled a prescription for a branded bupropion&#xD;
             product for depression alone&#xD;
&#xD;
          -  Under 18 years of age&#xD;
&#xD;
          -  Previous participation in a branded bupropion hydrochloride survey, which will be&#xD;
             determined via self-report in the survey&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>GlaxoSmithKline</affiliation>
  </overall_official>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>December 20, 2016</study_first_submitted>
  <study_first_submitted_qc>December 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 23, 2016</study_first_posted>
  <last_update_submitted>February 9, 2018</last_update_submitted>
  <last_update_submitted_qc>February 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 13, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>REMS</keyword>
  <keyword>Smoking cessation</keyword>
  <keyword>WELLBUTRIN</keyword>
  <keyword>ZYBAN</keyword>
  <keyword>Neuropsychiatric adverse events</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Depressive Disorder, Major</mesh_term>
  </condition_browse>
  <!-- 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/NCT03001440
org study id: 205913
nct id: NCT03001440
lead sponsor: 
collaborator: 
has dmc: No
Branded bupropion hydrochloride products including ZYBAN and WELLBUTRIN range are approved
      for the treatment of smoking cessation and depressive disorders respectively. The Risk
      Evaluation and Mitigation Strategy (REMS) for ZYBAN was initially approved in 2010 and
      consists of a Medication Guide and a timetable for REMS assessments submission at 18 months,
      3 years and 7 years from the date of initial approval of REMS. The present study is a 7-year
      REMS assessment to evaluate subjects' understanding of the potential serious risk of
      neuropsychiatric adverse events associated with the use of ZYBAN, WELLBUTRIN, WELLBUTRIN SR,
      and WELLBUTRIN XL. The assessment will be a 20-minutes Knowledge, Attitudes and Behavior
      (KAB) survey and will be conducted among approximately 125 subjects currently using or who
      have filled a prescription for a branded bupropion product for smoking cessation within the 6
      months prior to survey administration. ZYBAN, WELLBUTRIN, WELLBUTRIN SR, and WELLBUTRIN XL
      are registered trade marks of the GSK group of companies.
observational model: Cohort
time perspective: Cross-Sectional
measure: Number (No.) of subjects correctly responding to individual survey questions
time frame: 7 years
description: The proportion of correct answers to survey questions concerning the risks associated with branded bupropion hydrochloride products will be summarized by use of formulation of ZYBAN or WELLBUTRIN. Smoking behavior, demographic information, information related to the receipt and reading of the Medication Guides and how the branded bupropion hydrochloride product is normally received will also be reported. Point estimates for the proportion with correct responses will be calculated for each question about the risks of branded bupropion products. In the case of multiple choice questions, the number and proportion of subjects reporting each response will also be provided.
arm group label: ZYBAN/WELLBUTRIN users
description: Subjects who currently use or who have filled a prescription for ZYBAN, WELLBUTRIN, WELLBUTRIN SR, or WELLBUTRIN XL for smoking cessation within the previous 6 months will be included in the study. Subjects will be required to complete the KAB survey either online or through a telephone interview.
intervention type: Other
intervention name: KAB survey
description: The KAB survey will be conducted among study population to evaluate their understanding of the potential serious risk with the use of ZYBAN. The 20 minutes survey can be completed either online or through a telephone interview.
arm group label: ZYBAN/WELLBUTRIN users
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
responsible party type: Sponsor
mesh term: Depressive Disorder
mesh term: Depressive Disorder, Major