drugset / Trial / NCT01303861
Concurrent Bupropion / Varenicline for Smoking Cessation
Phase 3
Completed
702 enrolled
Duke University
National Institute on Drug Abuse (NIDA) · collabPhilip Morris USA · collab
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
Publications
- Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.
- Hartmann-Boyce J, Theodoulou A, Farley A, Hajek P, Lycett D, Jones LL, Kudlek L, Heath L, Hajizadeh A, Schenkels M, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2021 Oct 6;10(10):CD006219. doi: 10.1002/14651858.CD006219.pub4.
- Rose JE, Behm FM. Combination treatment with varenicline and bupropion in an adaptive smoking cessation paradigm. Am J Psychiatry. 2014 Nov 1;171(11):1199-205. doi: 10.1176/appi.ajp.2014.13050595.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — |