Clinical trial NCT03001440: A 7-year Assessment on Subject Understanding of ZYBAN/ WELLBUTRIN Associated Risks
Official title: Subject Understanding of the Risks Associated With ZYBAN®, WELLBUTRIN®, WELLBUTRIN SR®, and WELLBUTRIN XL®
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depressive Disorder, Major
Keywords: REMS
Smoking cessation
WELLBUTRIN
ZYBAN
Neuropsychiatric adverse events
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: United Biosource Corporation (UBC)
First posted: 2016-12-23
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects of age 18 years or older who are currently using or who have filled a prescription for branded bupropion hydrochloride products including ZYBAN, WELLBUTRIN, WELLBUTRIN SR, WELLBUTRIN XL within the 6 months prior to survey administration for smoking cessation.

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Number (No.) of subjects correctly responding to individual survey questions
timeFrame: 7 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: