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

Depressive Disorder, Major Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03001440
• Other study ID #: 205913
• Status: Completed
• Phase: N/A
• First received: December 20, 2016
• Last updated: February 9, 2018
• Start date: October 7, 2016
• Est. completion date: December 28, 2016

Study information

• Verified date: February 2018
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: December 28, 2016
• Est. primary completion date: December 28, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
GlaxoSmithKline	United Biosource Corporation (UBC)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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