Last updated: 07/21/2020 19:20:04

A 7-year assessment on subject understanding of ZYBAN/ WELLBUTRIN associated risks

GSK study ID
205913
See study documents
Clinicaltrials.gov ID
NCT03001440
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Subject Understanding of the Risks Associated with ZYBAN®, WELLBUTRIN®, WELLBUTRIN SR®, and WELLBUTRIN XL®
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number (No.) of subjects correctly responding to individual survey questions

Timeframe: 7 years

Secondary outcomes:
Not applicable
Interventions:
  • Other: KAB survey
    • Enrollment:
    1
    Primary completion date:
    2016-28-12
    Observational study model:
    Cohort
    Time perspective:
    Cross-Sectional
    Clinical publications:
    Ascher J, Stemhagen A, Stender M, Win B, Winter C.Patient Understanding of the Neuropsychiatric Risks Associated With Branded Bupropion Hydrochloride Products Used for Smoking Cessation.Drugs Reald World Outcomes.2018;5(3):181–191 DOI: 10.1007/s40801-018-0140-2 PMID: 30105744
    Medical condition
    Depressive Disorder, Major
    Product
    bupropion
    Collaborators
    United Biosource Corporation (UBC)
    Study date(s)
    October 2016 to December 2016
    Type
    Observational
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • 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. (Note: Branded bupropion hydrochloride product use will be confirmed through a series of questions within the screener concerning manufacturer information detailed on the product label [label on medication container] and following a review of photographs of generic bupropion, ZYBAN, WELLBUTRIN, WELLBUTRIN SR or WELLBUTRIN XL tablet types online or via a paper copy sent with the invitation letter for those who choose to participate via phone)
    • 18 years of age or older
    • Subjects taking generic bupropion
    • Subjects who currently use or who have filled a prescription for a branded bupropion product for depression alone
    Inclusion and exclusion criteria
    Inclusion criteria:
    • 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. (Note: Branded bupropion hydrochloride product use will be confirmed through a series of questions within the screener concerning manufacturer information detailed on the product label [label on medication container] and following a review of photographs of generic bupropion, ZYBAN, WELLBUTRIN, WELLBUTRIN SR or WELLBUTRIN XL tablet types online or via a paper copy sent with the invitation letter for those who choose to participate via phone)
    • 18 years of age or older
    • Fluent English speaker (for telephone)
    • Consent to take the online survey or have the survey administered via a telephone interview
    Exclusion criteria:
    • Subjects taking generic bupropion
    • Subjects who currently use or who have filled a prescription for a branded bupropion product for depression alone
    • Under 18 years of age
    • Previous participation in a branded bupropion hydrochloride survey, which will be determined via self-report in the survey

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Protocol
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    2016-28-12
    Actual study completion date
    2016-28-12

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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