A 7-year Assessment on Subject Understanding of ZYBAN/ WELLBUTRIN Associated Risks

Subject Understanding of the Risks Associated With ZYBAN®, WELLBUTRIN®, WELLBUTRIN SR®, and WELLBUTRIN XL®

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.

Study Overview

• Status: Completed
• Conditions: Depressive Disorder, Major
• Intervention / Treatment: Other: KAB survey

• Study Type: Observational
• Enrollment (Actual): 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ZYBAN/WELLBUTRIN users; 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.	Other: KAB survey; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number (No.) of subjects correctly responding to individual survey questions	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.	7 years

Collaborators and Investigators

• Sponsor: GlaxoSmithKline
• Collaborators: United Biosource Corporation (UBC)

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2016
• Primary Completion (Actual): December 28, 2016
• Study Completion (Actual): December 28, 2016

Study Registration Dates

• First Submitted: December 20, 2016
• First Submitted That Met QC Criteria: December 20, 2016
• First Posted (Estimate): December 23, 2016

Study Record Updates

• Last Update Posted (Actual): February 13, 2018
• Last Update Submitted That Met QC Criteria: February 9, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Smoking cessation; WELLBUTRIN; REMS; ZYBAN; Neuropsychiatric adverse events
• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: 205913