drugset / Trial / NCT02957786
Cytisine Versus Varenicline for Smoking Cessation
Phase 3
Completed
679 enrolled
University of Auckland, New Zealand
Brunel University · collabLakes District Health Board · collab
RandomizedParallel-groupSingle-blindTreatment
Summary
To evaluate the effectiveness, safety, and cost-effectiveness of cytisine plus behavioural support compared to varenicline plus behavioural support for smoking cessation, in indigenous Māori (or family of Māori) who smoke and are motivated to quit.
Timeline
- Start
- 2017-09-18
- Primary completion
- 2019-10-10
- Completion
- 2019-10-10
Outcome
Met primary endpoint
paper cytisine was at least as effective as varenicline at supporting smoking abstinence PMID 33761149 ↗
release “The published results indicate that cytisinicline met the pre-specified non-inferiority endpoint” achievelifesciences.com ↗
Publications
- Background Walker N, Smith B, Barnes J, Verbiest M, Kurdziel T, Parag V, Pokhrel S, Bullen C. Cytisine versus varenicline for smoking cessation for Maori (the indigenous people of New Zealand) and their extended family: protocol for a randomized non-inferiority trial. Addiction. 2019 Feb;114(2):344-352. doi: 10.1111/add.14449. Epub 2018 Nov 9.
- Results Walker N, Smith B, Barnes J, Verbiest M, Parag V, Pokhrel S, Wharakura MK, Lees T, Cubillos Gutierrez H, Jones B, Bullen C. Cytisine versus varenicline for smoking cessation in New Zealand indigenous Maori: a randomized controlled trial. Addiction. 2021 Oct;116(10):2847-2858. doi: 10.1111/add.15489. Epub 2021 May 4.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cytisine | Small molecule | 3 mg | — |
| Comparator | Varenicline | Small molecule | 2 mg | — |
Indications
No indication recorded.