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

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.

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Key information

Conditions

Depressive Disorder, Major Behavior Depressive Disorder Health Behavior Mental Disorders Mood Disorders Smoking Cessation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KAB survey

Other

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.

Primary outcomes

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

Time frame: 7 years

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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Collaborators

United Biosource Corporation (UBC)

Registry information

Official study title

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

Important dates

Study start: 2016
Primary completion: 2016
Study completion: 2016
First posted: Dec 23, 2016
Registry last updated: Feb 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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