drugset / Trial / NCT01303861

Concurrent Bupropion / Varenicline for Smoking Cessation

NCT01303861

RandomizedParallel-groupDouble-blindTreatment

Summary

This study focuses on the first step in developing an algorithm for maximizing quit-smoking success based on an adaptive approach, which changes treatment from the initial nicotine replacement therapy (NRT) when that treatment alone may not be sufficient. These NRT "non-responders" are switched (in double-blind fashion) before the quit date to receive either varenicline alone or varenicline paired with bupropion. Some participants who would otherwise have failed at their quit smoking attempt could be "rescued" by switching to alternative pharmacotherapies. The proposed study will evaluate the combination treatment against varenicline alone in an adaptive trial design

Timeline

Start
2011-03
Primary completion
2013-03
Completion
2013-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bupropion Small molecule 150 mg
Comparator Nicotine Unknown 21 mg Topical
Comparator Nicotine Unknown 42 mg Topical
Comparator Nicotine Unknown Inhaled
Comparator Varenicline Small molecule 1 mg

Indications