drugset / Trial / NCT03176784
UW Quitting Using Intensive Treatment Study (QUITS)
Phase 4
Completed
1251 enrolled
University of Wisconsin, Madison
National Heart, Lung, and Blood Institute (NHLBI) · collabWashington University School of Medicine · collab
RandomizedFactorialDouble-blindTreatment
Summary
This research will determine whether two highly promising modifications to varenicline treatment (i.e. use of a nicotine patch adjuvant and extended 24-week duration) produce superior smoking outcomes when they are either used together or alone. Despite their promise, the proposed modifications have never been experimentally evaluated relative to standard varenicline pharmacotherapy. Thus, this innovative research will produce novel evidence regarding how best to help smokers quit, and thereby address the leading cause of preventable mortality and morbidity related to cardiovascular and pulmonary diseases.
Timeline
- Start
- 2017-11-11
- Primary completion
- 2020-07-09
- Completion
- 2020-07-09
Publications
- Background Baker TB, Piper ME, Stein JH, Smith SS, Bolt DM, Fraser DL, Fiore MC. Effects of Nicotine Patch vs Varenicline vs Combination Nicotine Replacement Therapy on Smoking Cessation at 26 Weeks: A Randomized Clinical Trial. JAMA. 2016 Jan 26;315(4):371-9. doi: 10.1001/jama.2015.19284.
- Baker TB, Piper ME, Smith SS, Bolt DM, Stein JH, Fiore MC. Effects of Combined Varenicline With Nicotine Patch and of Extended Treatment Duration on Smoking Cessation: A Randomized Clinical Trial. JAMA. 2021 Oct 19;326(15):1485-1493. doi: 10.1001/jama.2021.15333.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nicotine patch | Unknown | 14 mg | — |
| Subject | Varenicline | Small molecule | 1 mg | — |