UW Quitting Using Intensive Treatment Study (QUITS)
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
Outcome
Missed primary endpoint
registry analysis (superiority test); Varenicline + Patch Standard Duration vs Varenicline Only Standard Duration; p = .66; Odds Ratio (OR) 0.9 (95% CI 0.6 to 1.3); Regression, Logistic NCT03176784 ↗
paper For the primary outcome, there was no significant interaction between the 2 treatment factors of medication type and medication duration (odds ratio (OR), 1.03 [95% CI, 0.91 to 1.17]; P = .66). PMID 34665204 ↗
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 | — |