drugset / Trial / NCT02271919
Varenicline and Combined NRT for Smoking Cessation
RandomizedParallel-groupDouble-blindTreatment
Summary
This randomized pilot phase IV trial studies the side effects and how well varenicline works compared to nicotine replacement therapy in helping patients that smoke to quit. Varenicline is a drug that acts the same way as nicotine in the brain but is not habit-forming. Nicotine replacement therapy consists of nicotine patches and lozenges. It is not yet known if varenicline is more effective than nicotine replacement therapy in helping patients quit smoking.
Timeline
- Start
- 2015-05-14
- Primary completion
- 2025-06-30
- Completion
- 2026-04-01
Publications
- Cinciripini PM, Green CE, Shete S, Minnix JA, Robinson JD, Cui Y, Kim S, Kypriotakis G, Beneventi D, Blalock JA, Versace F, Karam-Hage M. Smoking Cessation After Initial Treatment Failure With Varenicline or Nicotine Replacement: A Randomized Clinical Trial. JAMA. 2024 May 28;331(20):1722-1731. doi: 10.1001/jama.2024.4183.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nicotine | Unknown | 2 mg | Oral |
| Subject | Nicotine Patch | Unknown | 21 mg | Other |
| Subject | Nicotine Patch | Unknown | 42 mg | Other |
| Subject | Varenicline | Small molecule | 2 mg | Oral |
| Subject | Varenicline | Small molecule | 3 mg | Oral |